In related discoveries with far-reaching implications for treating diabetes and understanding hypertension, University of
Utah researchers have learned why thiazolidinediones (TZDs), a major anti-diabetes drug, cause edema and also have found a
new pathway critical to fluid metabolism. Identification of this pathway may help understand fundamental mechanisms of blood
pressure control.
Using knockout-gene technology, the U of U School of Medicine researchers found that when TZD activates a nuclear receptor,
the peroxisome proliferator-activated receptor gamma, in the collecting duct in the kidney, it serves as a mechanism for
fluid retention, or edema. The researchers suggest that the distal nephron, for example the collecting duct, is crucial for
regulation of sodium balance and blood pressure. The research is published this week in the Proceedings of the National
Academy of Sciences online.
The discoveries may point the way to developing different drugs to treat Type II diabetes and open an entirely new area in
the study of hypertension, according to Tianxin Yang, M.D., Ph.D., the two-year study's principal investigator, associate
professor of internal medicine at the U medical school, and staff physician at the George E. Wahler Veterans Affairs Medical
Center in Salt Lake City.
An estimated 18 million Americans suffer from diabetes. TZD compounds have been shown to be highly effective in lowering
blood glucose and lipid levels and in controlling blood pressure.
"It's almost a perfect drug for diabetes," Yang said.
But many diabetics who use TZD eventually have to discontinue the drug because it causes edema. About 1 percent of people who
take TZD get pulmonary edema and chronic heart failure, both being potentially life-threatening conditions.
TZD works by activating PPAR-gamma, a receptor that helps sensitize the body to insulin. PPAR is found in muscle, fat,
kidney, and heart and controls fatty acid and lipid metabolism. In the kidney, PPAR is found in the collecting duct, a
critical site for the control of fluid metabolism.
To test the role of PPAR in edema, Yang created mice that specifically lacked PPAR-gamma in the collecting duct. He then
administered TZD to these mice, as well as to a control group that didn't lack PPAR-gamma.
The mice not lacking PPAR-gamma showed about a 10 percent average increase in body weight because of fluid retention. The
blood plasma volume of these mice increased by one-third, Yang said. But the mice bred without PPAR-gamma experienced no
increase in body weight in response to the drug, according to Yang.
"This tells us that the body weight gain is regulated by PPAR-gamma in the collecting duct," he said. "We also found this
drug decreased the sodium excretion in urine, so this could explain the fluid retention."
The mice without PPAR in the collecting ducts incurred no changes in sodium reabsorption, while those with PPAR excreted less
sodium through urination. Yang said that the distal nephron, which is usually subject to hormone regulation in the kidney,
serves as a key pathway for keeping an accurate amount of sodium in the body.
Hypertension affects one in four U.S. adults and long had been considered a cardiovascular disease. But research now also
focuses on the kidneys and the role of the distal nephron in retaining sodium opens a new area for study, he said.
University of Utah Health Sciences Center
50 N. Medical Dr.
Salt Lake City, UT 84132
United States
hsc.utah/uuhsc/news
суббота, 14 мая 2011 г.
Wound Management Technologies Expands Distribution Foot Print In Florida With The Addition Of Central Medical Systems
Wound Management Technologies, Inc. (OTC Bulletin Board: WNDM) announced that its subsidiary Wound Care Innovations, LLC has further expanded its rapidly growing coverage of the Florida wound care market with the addition of Central Medical Systems to its already extensive list of distributors and suppliers. "A company like CMSI is the ideal type of distributor; they have credibility and an established history in the market and understand the business of wound care especially for diabetic patients. I look forward to a very fruitful relationship," stated Ron Mathis, Sr. VP of Marketing and Sales for Wound Care Innovations, LLC.
Trent Harley, President of Central Medical Systems was quoted as saying, "We are excited to be a new distributor for Cellerate RX®. Over the past year, CMSI has observed the demand for Cellerate RX® outpacing the growth of other collagen-based wound care products being sold in the Florida market."
Central Medical Systems of Winter Park, Florida is a full service medical supply company, serving the wound care professional, and patients in need of wound care or diabetic supplies.
Safe Harbor Statement:
The statements in the press release that relate to the company's expectations with regard to the future impact on the company's results from new products in development and any other statements not constituting historical facts are "forward-looking statements," within the meaning of and subject to the safe harbor created by the Private Securities Litigation Reform Act of 1995. Since this information may contain statements that involve risk and uncertainties and are subject to change at any time, the company's actual results may differ materially from expected results. This document may contain forward-looking statements concerning the Company's operations, current and future performance and financial condition. These items involve risks, contingencies and uncertainties such as product demand, market and customer acceptance, the effect of economic conditions, competition, pricing, the ability to consummate and integrate acquisitions, and other risks, contingencies and uncertainties detailed in the Company's SEC filings, which could cause the company's actual operating results, performance or business plans or prospects to differ materially from those expressed in, or implied by these statements. The Company undertakes no obligation to revise any of these statements to reflect the future circumstances or the occurrence of unanticipated events.
Trent Harley, President of Central Medical Systems was quoted as saying, "We are excited to be a new distributor for Cellerate RX®. Over the past year, CMSI has observed the demand for Cellerate RX® outpacing the growth of other collagen-based wound care products being sold in the Florida market."
Central Medical Systems of Winter Park, Florida is a full service medical supply company, serving the wound care professional, and patients in need of wound care or diabetic supplies.
Safe Harbor Statement:
The statements in the press release that relate to the company's expectations with regard to the future impact on the company's results from new products in development and any other statements not constituting historical facts are "forward-looking statements," within the meaning of and subject to the safe harbor created by the Private Securities Litigation Reform Act of 1995. Since this information may contain statements that involve risk and uncertainties and are subject to change at any time, the company's actual results may differ materially from expected results. This document may contain forward-looking statements concerning the Company's operations, current and future performance and financial condition. These items involve risks, contingencies and uncertainties such as product demand, market and customer acceptance, the effect of economic conditions, competition, pricing, the ability to consummate and integrate acquisitions, and other risks, contingencies and uncertainties detailed in the Company's SEC filings, which could cause the company's actual operating results, performance or business plans or prospects to differ materially from those expressed in, or implied by these statements. The Company undertakes no obligation to revise any of these statements to reflect the future circumstances or the occurrence of unanticipated events.
Taking Control Of Your Diabetes Conference Returns To Raleigh To Bring Answers, Advocacy And Hope For People With Diabetes
Taking Control of Your Diabetes (TCOYD) conference and health fair will be held May 2, 2009 at the Raleigh Convention Center, bringing national and local medical experts in diabetes care to people with all types of diabetes, those at risk for diabetes, and their loved ones for a day of highly informative and motivational programs.
Leading specialists will discuss practical advice and developments in the treatment of diabetes, the complications of the disease, psychological barriers to controlling diabetes, prevention, nutritional issues, heart disease and much more. The Taking Control of Your Diabetes conference is a collaborative effort of health professionals from major institutions and clinics including the University of North Carolina Health Care, Duke University Medicine, and Raleigh Endocrine Associates. The American Diabetes Association and North Carolina Diabetes Prevention and Control, among many other agencies and organizations, have partnered with TCOYD to present the 8th Taking Control of Your Diabetes event in Raleigh.
TCOYD participants can hear lectures, participate in screenings, and speak one-on-one with diabetes specialists including physicians, pharmacists, dietitians, certified diabetes educators, dentists, ophthalmologists and podiatrists.
A health fair with 40 informational exhibits from national and local diabetes-related companies and organizations will be open throughout the day. A banquet lunch is included and will feature special guest speaker Urban Miyares, blinded Vietnam veteran. Presumed dead following an ambush on his platoon, Miyares was found in a diabetic coma in a body bag, and subsequently diagnosed with diabetes. Miyares has succeeded in his life and career as an entrepreneur, motivational speaker, mentor, television and film personality, and world-class athlete.
"Diabetes is demanding and people's daily decisions have an immediate impact on their health. At the same time, information about living with diabetes is complex. Education is critical to staying on top of this disease. We are delighted to have TCOYD back in Raleigh," said endocrinologist and Conference Co-Director John Buse, MD.
There will also be a post-conference Meet & Greet from 5 to 6:00 p.m. for women with diabetes, co-hosted by TCOYD and Diabetes Sisters.
TCOYD founder and director Steven Edelman, MD, an internationally recognized leader in diabetes treatment, research and education, who has lived with diabetes for 37 years, says, "One of the biggest differences between diabetes and other diseases is that diabetes control is in the hands of the patients, not the doctors. This TCOYD conference will give people an edge on the information and empowerment they need to live well with diabetes."
TCOYD is a California-based 501c3 diabetes education organization. This is the 105th in the national series of conferences that the not-for-profit has presented since 1995. 2,000 participants are expected at this one-of-a-kind event.
Leading specialists will discuss practical advice and developments in the treatment of diabetes, the complications of the disease, psychological barriers to controlling diabetes, prevention, nutritional issues, heart disease and much more. The Taking Control of Your Diabetes conference is a collaborative effort of health professionals from major institutions and clinics including the University of North Carolina Health Care, Duke University Medicine, and Raleigh Endocrine Associates. The American Diabetes Association and North Carolina Diabetes Prevention and Control, among many other agencies and organizations, have partnered with TCOYD to present the 8th Taking Control of Your Diabetes event in Raleigh.
TCOYD participants can hear lectures, participate in screenings, and speak one-on-one with diabetes specialists including physicians, pharmacists, dietitians, certified diabetes educators, dentists, ophthalmologists and podiatrists.
A health fair with 40 informational exhibits from national and local diabetes-related companies and organizations will be open throughout the day. A banquet lunch is included and will feature special guest speaker Urban Miyares, blinded Vietnam veteran. Presumed dead following an ambush on his platoon, Miyares was found in a diabetic coma in a body bag, and subsequently diagnosed with diabetes. Miyares has succeeded in his life and career as an entrepreneur, motivational speaker, mentor, television and film personality, and world-class athlete.
"Diabetes is demanding and people's daily decisions have an immediate impact on their health. At the same time, information about living with diabetes is complex. Education is critical to staying on top of this disease. We are delighted to have TCOYD back in Raleigh," said endocrinologist and Conference Co-Director John Buse, MD.
There will also be a post-conference Meet & Greet from 5 to 6:00 p.m. for women with diabetes, co-hosted by TCOYD and Diabetes Sisters.
TCOYD founder and director Steven Edelman, MD, an internationally recognized leader in diabetes treatment, research and education, who has lived with diabetes for 37 years, says, "One of the biggest differences between diabetes and other diseases is that diabetes control is in the hands of the patients, not the doctors. This TCOYD conference will give people an edge on the information and empowerment they need to live well with diabetes."
TCOYD is a California-based 501c3 diabetes education organization. This is the 105th in the national series of conferences that the not-for-profit has presented since 1995. 2,000 participants are expected at this one-of-a-kind event.
American Society Of Hypertension Updates Guidelines To Address 7-Fold Mortality Increase In Hypertensive Patients With Diabetes
Updated guidance published in the current issue of the American Society of Hypertension's (ASH) Journal of Clinical Hypertension addresses the urgent need for physicians to take a more integrated, individualized approach to treating hypertension (high blood pressure) in patients with diabetes by treating the intricacies of each patient profile, rather than focusing on the disease in isolation. Early initiation of medications that block the renin angiotension system (ACE inhibitors or ARBs) coupled with either thiazide-like diuretics or calcium antagonists are needed to maintain BP
"Diabetes is a complex disease in which blood pressure control is imperative, but it requires more than blood pressure control alone to be most effective," explained Henry Black, MD, president of the American Society of Hypertension. "Our medical organization is providing physicians with more up-to-date guidance on how to assess and treat hypertensive patients with diabetes and we are saying 'act globally' to improve cardiovascular health."
Current guidelines advise that patients start on a combination antihypertensive therapy, ideally in a single pill to improve patient adherence, if blood pressure is greater than 20/10 mmHg above recommended target levels. ASH's new guidance reinforces this concept and provides specific data demonstrating how to initiate treatment and follow up with patients to achieve target blood pressure goals.
About the American Society of Hypertension
The American Society of Hypertension (ASH) is the largest U.S. organization devoted exclusively to hypertension and related cardiovascular diseases. ASH is committed to alerting physicians, allied health professionals and the public about new medical options, facts, research findings and treatment choices designed to reduce the risk of cardiovascular disease. For more information, please visit ash-us.
The authors of The Journal of Clinical Hypertension Position Paper were George L. Bakris, MD and James R. Sowers, MD, on behalf of the Hypertension Writing Group.
About The Journal of Clinical Hypertension
The Journal of Clinical Hypertension (JCH), published by Wiley-Blackwell provides unbiased, peer-reviewed, clinically relevant information to a wide audience of practicing physicians treating hypertension and cardiovascular disease. It is distributed monthly to approximately 40,000 physicians in the United States, including cardiologists, family practitioners and internists, with the primary objective of bridging the "knowledge-practice gap" between researchers and practicing clinicians. The Journal of Clinical Hypertension became an official journal of the American Society of Hypertension in 2005 and is listed in the National Library of Medicine's Index Medicus.
American Society of Hypertension (ASH)
148 Madison Ave., 5th Fl.
New York, NY 10016
United States
ash-us
"Diabetes is a complex disease in which blood pressure control is imperative, but it requires more than blood pressure control alone to be most effective," explained Henry Black, MD, president of the American Society of Hypertension. "Our medical organization is providing physicians with more up-to-date guidance on how to assess and treat hypertensive patients with diabetes and we are saying 'act globally' to improve cardiovascular health."
Current guidelines advise that patients start on a combination antihypertensive therapy, ideally in a single pill to improve patient adherence, if blood pressure is greater than 20/10 mmHg above recommended target levels. ASH's new guidance reinforces this concept and provides specific data demonstrating how to initiate treatment and follow up with patients to achieve target blood pressure goals.
About the American Society of Hypertension
The American Society of Hypertension (ASH) is the largest U.S. organization devoted exclusively to hypertension and related cardiovascular diseases. ASH is committed to alerting physicians, allied health professionals and the public about new medical options, facts, research findings and treatment choices designed to reduce the risk of cardiovascular disease. For more information, please visit ash-us.
The authors of The Journal of Clinical Hypertension Position Paper were George L. Bakris, MD and James R. Sowers, MD, on behalf of the Hypertension Writing Group.
About The Journal of Clinical Hypertension
The Journal of Clinical Hypertension (JCH), published by Wiley-Blackwell provides unbiased, peer-reviewed, clinically relevant information to a wide audience of practicing physicians treating hypertension and cardiovascular disease. It is distributed monthly to approximately 40,000 physicians in the United States, including cardiologists, family practitioners and internists, with the primary objective of bridging the "knowledge-practice gap" between researchers and practicing clinicians. The Journal of Clinical Hypertension became an official journal of the American Society of Hypertension in 2005 and is listed in the National Library of Medicine's Index Medicus.
American Society of Hypertension (ASH)
148 Madison Ave., 5th Fl.
New York, NY 10016
United States
ash-us
How Mobile Technology Can Help Patients Manage Diabetes
The McKesson Foundation has announced the six recipients of $1.3 million in research grants as part of its Mobilizing for Healthsm initiative to improve the health of underserved populations with chronic diseases through the use of mobile-phone technology. The Mobilizing for Healthsm grants, of up to $250,000 each, will support studies on diabetes care and management at six esteemed U.S. institutions. The Mobilizing for Health grant program dedicates $1.5 million annually to research grants and field-building activities, such as mobile health conference support and other mHealth field building activities.
Mobile health, or "mHealth," is a term used for the practice of medicine that relies on wireless devices, such as mobile phones, PDAs and remote monitoring devices, to improve patient care.
The studies will examine a range of mobile-health technology options from sending simple SMS text messages to patients to remind them to take their medications to a comprehensive mobile phone-based software program that is integrated with patients' electronic medical records. Each study will be completed within one year, several will test bilingual (Spanish and English) messaging strategies, and all are designed around patient populations served by community health clinics.
"These studies are part of an ongoing Foundation effort to tie innovative technologies to low-cost, scalable health solutions in order to better help patients manage their chronic conditions," noted Carrie Varoquiers, president of the McKesson Foundation. "Through initiatives like Mobilizing for Healthsm, the McKesson Foundation is committed to increasing access to affordable, high-quality healthcare for all."
The first cycle of Mobilizing for Healthsm grant recipients are:
Joshua Cohen, M.D., and Neal Sikka, M.D., of George Washington University
SMS messaging to reduce emergency department visits for people with diabetes
Samir Patel M.D., of George Washington University
Enhancing diabetes and hypertension self-management: A randomized trial of a mobile phone strategy
Lawrence Cheskin, M.D., FACP, of Johns Hopkins Bloomberg School of Health
Tailored Rapid Interactive Mobile Messaging (TRIMM) for weight control among the underserved
Kevin Clauson, Pharm.D., of Nova Southeastern University
Pilot study to assess the impact of SMS/text messages on medication adherence for Type 2 diabetes
David Lindeman, MSW, Ph.D., of the Public Health Institute
Patient-centered mHealth: New horizons in diabetes care at Family Health Centers of San Diego
Sanjay Arora, M.D., Michael Menchine, M.D., and Anne Peters, M.D., at the University of Southern California
Improving diabetes care for low-income Latino patients in the Los Angeles County healthcare system
The Impact of Diabetes
Diabetes poses a serious and growing health risk in the United States. According to the American Diabetes Association:
25.8 million American children and adults have diabetes (8.3% of the population) 79 million people in the United States have pre-diabetes
$174 billion was spent in the United States in 2007 on direct medical costs and indirect costs, such as work loss and premature mortality
Minority populations disproportionately suffer from diabetes and diabetes-related complications
The McKesson Foundation pledged to put diabetes management at the forefront of its Mobilizing for Healthsm grant program when it launched the initiative in April 2010, and will continue to focus its funding priorities on diabetes management and research through March 2012.
Mobile health, or "mHealth," is a term used for the practice of medicine that relies on wireless devices, such as mobile phones, PDAs and remote monitoring devices, to improve patient care.
The studies will examine a range of mobile-health technology options from sending simple SMS text messages to patients to remind them to take their medications to a comprehensive mobile phone-based software program that is integrated with patients' electronic medical records. Each study will be completed within one year, several will test bilingual (Spanish and English) messaging strategies, and all are designed around patient populations served by community health clinics.
"These studies are part of an ongoing Foundation effort to tie innovative technologies to low-cost, scalable health solutions in order to better help patients manage their chronic conditions," noted Carrie Varoquiers, president of the McKesson Foundation. "Through initiatives like Mobilizing for Healthsm, the McKesson Foundation is committed to increasing access to affordable, high-quality healthcare for all."
The first cycle of Mobilizing for Healthsm grant recipients are:
Joshua Cohen, M.D., and Neal Sikka, M.D., of George Washington University
SMS messaging to reduce emergency department visits for people with diabetes
Samir Patel M.D., of George Washington University
Enhancing diabetes and hypertension self-management: A randomized trial of a mobile phone strategy
Lawrence Cheskin, M.D., FACP, of Johns Hopkins Bloomberg School of Health
Tailored Rapid Interactive Mobile Messaging (TRIMM) for weight control among the underserved
Kevin Clauson, Pharm.D., of Nova Southeastern University
Pilot study to assess the impact of SMS/text messages on medication adherence for Type 2 diabetes
David Lindeman, MSW, Ph.D., of the Public Health Institute
Patient-centered mHealth: New horizons in diabetes care at Family Health Centers of San Diego
Sanjay Arora, M.D., Michael Menchine, M.D., and Anne Peters, M.D., at the University of Southern California
Improving diabetes care for low-income Latino patients in the Los Angeles County healthcare system
The Impact of Diabetes
Diabetes poses a serious and growing health risk in the United States. According to the American Diabetes Association:
25.8 million American children and adults have diabetes (8.3% of the population) 79 million people in the United States have pre-diabetes
$174 billion was spent in the United States in 2007 on direct medical costs and indirect costs, such as work loss and premature mortality
Minority populations disproportionately suffer from diabetes and diabetes-related complications
The McKesson Foundation pledged to put diabetes management at the forefront of its Mobilizing for Healthsm grant program when it launched the initiative in April 2010, and will continue to focus its funding priorities on diabetes management and research through March 2012.
JDRF Clinical Panel Recommends Next Steps For Artificial Pancreas Clinical Testing
Diabetes experts at a meeting convened by the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) took the next step in advancing efforts toward the development of an artificial pancreas: putting forth clinical recommendations to ensure the safe and effective testing of artificial pancreas technology in real-life situations. We are pleased at today's meeting there was a strong consensus among leading clinicians, researchers and industry leaders regarding the path toward outpatient studies for both low-glucose suspend and artificial pancreas systems.
Even with treatments available today, tight blood sugar control remains a challenge and daily struggle for those living with type 1 diabetes. In fact, the majority of people living with the disease are not achieving recommended target levels. "An artificial pancreas, essentially a device that would both measure blood sugar and dispense appropriate amounts of insulin to keep levels in optimal range, would take much of the guesswork out of daily management of the disease," said Dr. Aaron Kowalski, Assistant Vice President of Treatment Therapies at JDRF. "In the long-run, controlled blood sugar levels will help to lessen or avert the devastating complications from type 1 diabetes."
To date, artificial pancreas devices have been successfully tested in controlled inpatient or hospital settings, demonstrating the potential for this technology to improve blood sugar control. Now it must be tested safely in real-world conditions. And clear and reasonable regulatory guidelines must be established to ensure that the upcoming studies advance the technology to reach patients as soon as possible.
"We believe a safe and effective first generation artificial pancreas system is possible with today's technology, even as we continue to encourage development of improved devices. Experts at today's FDA workshop outlined a clear path forward to safely speed the development and delivery of artificial pancreas systems to patients," said Jeffrey Brewer, President and CEO of JDRF.
To help advance these efforts, JDRF formed a Clinical Panel of internationally renowned leaders in the diabetes field to make recommendations to FDA on key clinical steps and issues critical to the advancement of studies of these systems outside of the hospital. Panel members speaking at today's workshop included David Nathan, Director, Clinical Research Center and Diabetes Center at Massachusetts General Hospital and Professor of Medicine, Harvard Medical School; and William Tamborlane, Professor and Chief of Pediatric Endocrinology and Diabetes, Yale University School of Medicine.
The panel developed a series of clinical recommendations that were shared at today's meeting. They were based on key areas addressed by the FDA, NIH, JDRF, clinicians and industry. First, the recommendations addressed questions on how should studies on artificial pancreas systems move safely from inpatient (hospital) settings to outpatient (real-world) testing. Second, the panel identified which subset of patients should be considered when testing artificial pancreas systems. The third area focused on how to ensure the safety of patients participating in the studies and eventually for everyday use. Lastly, the panel identified what outcomes should be measured in studies to demonstrate the safety and effectiveness of the device.
According to panel chair Robert Sherwin, M.D., Yale University, "The panel believes, with certain safeguards, artificial pancreas systems can be safely tested in real world settings."
"The incidence of type 1 diabetes is on the rise. Today's tools to manage the disease are insufficient. We have the technology at our disposal to make an artificial pancreas work. Now it's time to move forward quickly to define the regulatory pathway so final studies can be completed and better technologies can be made available to adults and children struggling with this difficult disease," added Mr. Brewer.
About JDRF's Artificial Pancreas Project
JDRF launched the Artificial Pancreas Project in 2005 to speed the development of automated diabetes management systems. A self-regulating system, the artificial pancreas would be able to sense sugar levels continuously and automatically release the right amount of insulin at the right times eliminating the need for multiple blood tests, insulin injections and therefore lifting the daily burden associated with managing diabetes.
Since that time, JDRF has supported a number of initiatives that have advanced progress toward the development of an artificial pancreas. This has included the formation of the Artificial Pancreas Consortium, a group of university-based mathematicians, engineers, and diabetes experts to develop the computer algorithms that are needed to connect the devices needed to form a closed-loop system.
In addition to the consortium, JDRF has collaborated with several industry partners to develop a first-generation artificial pancreas system, as well as better and faster-acting insulin products, a key component of developing a safe and effective artificial pancreas system.
Even with treatments available today, tight blood sugar control remains a challenge and daily struggle for those living with type 1 diabetes. In fact, the majority of people living with the disease are not achieving recommended target levels. "An artificial pancreas, essentially a device that would both measure blood sugar and dispense appropriate amounts of insulin to keep levels in optimal range, would take much of the guesswork out of daily management of the disease," said Dr. Aaron Kowalski, Assistant Vice President of Treatment Therapies at JDRF. "In the long-run, controlled blood sugar levels will help to lessen or avert the devastating complications from type 1 diabetes."
To date, artificial pancreas devices have been successfully tested in controlled inpatient or hospital settings, demonstrating the potential for this technology to improve blood sugar control. Now it must be tested safely in real-world conditions. And clear and reasonable regulatory guidelines must be established to ensure that the upcoming studies advance the technology to reach patients as soon as possible.
"We believe a safe and effective first generation artificial pancreas system is possible with today's technology, even as we continue to encourage development of improved devices. Experts at today's FDA workshop outlined a clear path forward to safely speed the development and delivery of artificial pancreas systems to patients," said Jeffrey Brewer, President and CEO of JDRF.
To help advance these efforts, JDRF formed a Clinical Panel of internationally renowned leaders in the diabetes field to make recommendations to FDA on key clinical steps and issues critical to the advancement of studies of these systems outside of the hospital. Panel members speaking at today's workshop included David Nathan, Director, Clinical Research Center and Diabetes Center at Massachusetts General Hospital and Professor of Medicine, Harvard Medical School; and William Tamborlane, Professor and Chief of Pediatric Endocrinology and Diabetes, Yale University School of Medicine.
The panel developed a series of clinical recommendations that were shared at today's meeting. They were based on key areas addressed by the FDA, NIH, JDRF, clinicians and industry. First, the recommendations addressed questions on how should studies on artificial pancreas systems move safely from inpatient (hospital) settings to outpatient (real-world) testing. Second, the panel identified which subset of patients should be considered when testing artificial pancreas systems. The third area focused on how to ensure the safety of patients participating in the studies and eventually for everyday use. Lastly, the panel identified what outcomes should be measured in studies to demonstrate the safety and effectiveness of the device.
According to panel chair Robert Sherwin, M.D., Yale University, "The panel believes, with certain safeguards, artificial pancreas systems can be safely tested in real world settings."
"The incidence of type 1 diabetes is on the rise. Today's tools to manage the disease are insufficient. We have the technology at our disposal to make an artificial pancreas work. Now it's time to move forward quickly to define the regulatory pathway so final studies can be completed and better technologies can be made available to adults and children struggling with this difficult disease," added Mr. Brewer.
About JDRF's Artificial Pancreas Project
JDRF launched the Artificial Pancreas Project in 2005 to speed the development of automated diabetes management systems. A self-regulating system, the artificial pancreas would be able to sense sugar levels continuously and automatically release the right amount of insulin at the right times eliminating the need for multiple blood tests, insulin injections and therefore lifting the daily burden associated with managing diabetes.
Since that time, JDRF has supported a number of initiatives that have advanced progress toward the development of an artificial pancreas. This has included the formation of the Artificial Pancreas Consortium, a group of university-based mathematicians, engineers, and diabetes experts to develop the computer algorithms that are needed to connect the devices needed to form a closed-loop system.
In addition to the consortium, JDRF has collaborated with several industry partners to develop a first-generation artificial pancreas system, as well as better and faster-acting insulin products, a key component of developing a safe and effective artificial pancreas system.
UC Davis Researchers Discover Novel Pathway To Increased Inflammation In Diabetes Patients
Researchers at UC Davis Health System have
discovered a novel pathway that results in increased inflammation of blood
vessels in patients with type 1 diabetes. Their findings suggest that,
with
good diabetes control, this inflammation may be reduced, possibly
resulting
in a reduction of cardiovascular disease as well.
In a study now available both in the online edition of the Journal of
Clinical Endocrinology & Metabolism as well on the National Institutes of
Health's PubMed, the researchers provide the first-ever demonstration of
increased expression and signaling in type 1 diabetics of two key
receptors
within the body's innate immune system. Called TLR2 and TLR4, they are
part
of a family of pattern recognition receptors known as Toll-like receptors
(TLRs), so-called because of their similarities to the well-defined Toll
gene found in much-studied fruit flies.
Type 1 diabetes is a pro-inflammatory state associated with increased
cardiovascular mortality. Inflammation plays a pivotal role in all stages
of atherosclerosis, the progressive narrowing and hardening of the
arteries
over time. The UC Davis study found that TLR2 and TLR4 expression and
signaling are increased in type 1 diabetes patients and contribute to the
pro-inflammatory state.
"It is not unreasonable to speculate that TLR2 and TLR4 promote
atherogenesis by contributing to the pro-inflammatory state in type 1
diabetes," said lead author Ishwarlal Jialal, director of the Laboratory
for Atherosclerosis and Metabolic Research and professor of internal
medicine at UC Davis. "Inflammation is central to heart disease, playing a
pivotal role in plaque formation and stroke. We may well find that a
serendipitous byproduct of controlling diabetes is the simultaneous
control
of this new pathway, leading to less inflammation and lower risk of heart
problems."
The study represents the first-ever demonstration of increased TLR2 and
TLR4 activity in type 1 diabetes monocytes, which are part of the body's
immune system, protecting against blood-borne pathogens by moving quickly
to sites of infection. The immune system comprises the cells and
mechanisms
that defend the host from infection by other organisms, accomplishing its
defense with the help of such pattern-recognition receptors as TLRs for
early detection of specific classes of pathogens.
"This finding provides us with a totally new insight into the causes of
inflammation in diabetics," adds Jialal, who holds the Robert E. Stowell
Endowed Chair in Experimental Pathology at UC Davis. "It's an exciting
development in the emerging area of TLR research that has potentially
wide-ranging implications."
Further studies will use mice to examine the molecular mechanisms for
increased TLR2 and TLR4 expression and determine their contribution to the
pro-inflammatory state of diabetes.
Co-authors were Sridevi Devaraj, Mohan Dasu and Jason Rockwood in the UC
Davis Laboratory for Atherosclerosis and Metabolic Research; Steven
Griffen, UC Davis assistant professor of endocrinology, clinical nutrition
and vascular medicine; and William Winter, professor of pathology,
immunology and laboratory medicine at the University of Florida.
The study was funded by grants from the Juvenile Diabetes Research
Foundation International and the National Institutes of Health.
UC Davis Health System is the leading tertiary care provider for a
33-county region of Northern California. Research strengths at UC Davis
Health System include clinical and translational science, stem cell
science, infectious diseases, vascular biology, neuroscience, cancer,
functional genomics and mouse biology, comparative medicine, combinatorial
chemistry and nutrition, among many others.
UC Davis Health System
discovered a novel pathway that results in increased inflammation of blood
vessels in patients with type 1 diabetes. Their findings suggest that,
with
good diabetes control, this inflammation may be reduced, possibly
resulting
in a reduction of cardiovascular disease as well.
In a study now available both in the online edition of the Journal of
Clinical Endocrinology & Metabolism as well on the National Institutes of
Health's PubMed, the researchers provide the first-ever demonstration of
increased expression and signaling in type 1 diabetics of two key
receptors
within the body's innate immune system. Called TLR2 and TLR4, they are
part
of a family of pattern recognition receptors known as Toll-like receptors
(TLRs), so-called because of their similarities to the well-defined Toll
gene found in much-studied fruit flies.
Type 1 diabetes is a pro-inflammatory state associated with increased
cardiovascular mortality. Inflammation plays a pivotal role in all stages
of atherosclerosis, the progressive narrowing and hardening of the
arteries
over time. The UC Davis study found that TLR2 and TLR4 expression and
signaling are increased in type 1 diabetes patients and contribute to the
pro-inflammatory state.
"It is not unreasonable to speculate that TLR2 and TLR4 promote
atherogenesis by contributing to the pro-inflammatory state in type 1
diabetes," said lead author Ishwarlal Jialal, director of the Laboratory
for Atherosclerosis and Metabolic Research and professor of internal
medicine at UC Davis. "Inflammation is central to heart disease, playing a
pivotal role in plaque formation and stroke. We may well find that a
serendipitous byproduct of controlling diabetes is the simultaneous
control
of this new pathway, leading to less inflammation and lower risk of heart
problems."
The study represents the first-ever demonstration of increased TLR2 and
TLR4 activity in type 1 diabetes monocytes, which are part of the body's
immune system, protecting against blood-borne pathogens by moving quickly
to sites of infection. The immune system comprises the cells and
mechanisms
that defend the host from infection by other organisms, accomplishing its
defense with the help of such pattern-recognition receptors as TLRs for
early detection of specific classes of pathogens.
"This finding provides us with a totally new insight into the causes of
inflammation in diabetics," adds Jialal, who holds the Robert E. Stowell
Endowed Chair in Experimental Pathology at UC Davis. "It's an exciting
development in the emerging area of TLR research that has potentially
wide-ranging implications."
Further studies will use mice to examine the molecular mechanisms for
increased TLR2 and TLR4 expression and determine their contribution to the
pro-inflammatory state of diabetes.
Co-authors were Sridevi Devaraj, Mohan Dasu and Jason Rockwood in the UC
Davis Laboratory for Atherosclerosis and Metabolic Research; Steven
Griffen, UC Davis assistant professor of endocrinology, clinical nutrition
and vascular medicine; and William Winter, professor of pathology,
immunology and laboratory medicine at the University of Florida.
The study was funded by grants from the Juvenile Diabetes Research
Foundation International and the National Institutes of Health.
UC Davis Health System is the leading tertiary care provider for a
33-county region of Northern California. Research strengths at UC Davis
Health System include clinical and translational science, stem cell
science, infectious diseases, vascular biology, neuroscience, cancer,
functional genomics and mouse biology, comparative medicine, combinatorial
chemistry and nutrition, among many others.
UC Davis Health System
63% Of Diabetics Risk Serious Foot Problems By Wearing The Wrong Sized Shoes
More than six out of ten people with diabetes are walking around in the wrong-sized shoes, exposing themselves to serious foot problems that could lead to amputation, according to research in the November issue of IJCP, the International Journal of Clinical Practice.
Published to coincide with World Diabetes Day (14 November) the study, by the University of Dundee, has been welcomed by an expert in podiatry. She says that ulceration can have serious implications for patients and health services, including impaired quality of life, increased amputation risk and even elevated death rates.
The United Nations, which passed a landmark resolution in December 2006 recognising diabetes as a chronic, debilitating and costly disease, has designated World Diabetes Day as an official United Nations Day for the first time in 2007.
And the World Health Organization has said that the number of people suffering from diabetes could double to 366 million by 2030 and that 80 per cent of diabetic foot amputations could be prevented.
A hundred patients aged 24 to 89 volunteered to take part in the shoe-size study carried out at a general diabetic clinic at Ninewells Hospital Medical School in Dundee, Scotland.
Patients who were also attending specialist foot clinics were excluded, as were patients who had problems standing or were wearing specially provided footwear.
"All the patients had their feet fully examined and measured while they were both sitting and standing" explains co-author Dr Graham Leese, a consultant at the clinic, which forms part of University of Dundee.
The team found that 63 per cent of the patients were wearing the wrong-sized shoes. For example, 45 per cent were wearing the wrong width fitting, with the majority being too narrow.
"When people stand up their feet change shape as the arch of the foot flattens and the foot becomes wider and longer" explains Dr Leese. "Taking both these sets of
measurements into account, only 37 per cent of the patients were actually wearing the right-sized shoes.
"Interestingly, patients who didn't have problems with lack of feeling in their feet a common problem with diabetes - were just as likely to wear badly fitting shoes as those who did.
"We also discovered that almost a third of the patients said they took a different shoe size to the one they were actually wearing. This isn't helped by the fact that shoe sizes vary from make to make."
45 per cent of the volunteers had experienced previous problems with their feet, including ulcers, callouses, bunions, corns or swelling. Despite this, 22 per cent never checked their own feet and only 29 per cent checked them daily.
Foot problems could be reduced by adults being offered foot-measuring services in shoe shops, say the researchers. They would also like to see manufacturers developing standardised shoe sizes and expanding the range of length and width fittings that they offer, especially for patients who have no feeling in their feet.
Podiatry expert Andrea Parnes, from the University of Ulster, agrees. She points out that, given the scale of the problem, it would make commercial sense for manufacturers to work with health professionals to expand their existing ranges.
In her accompanying editorial she calls for greater research into the problem, pointing out that the study also raises concerns about patients with conditions like rheumatoid arthritis.
The current issue of IJCP also includes a special supplement, which expresses support for the United Nation's resolution on diabetes and highlights practical examples that have been shown to improve diabetes care.
These range from raising government awareness worldwide to empowering patients at grassroots level.
BLACKWELL PUBLISHING LTD
9600 Garsington Road
Oxford OX4 2DQ
blackwellpublishing
Published to coincide with World Diabetes Day (14 November) the study, by the University of Dundee, has been welcomed by an expert in podiatry. She says that ulceration can have serious implications for patients and health services, including impaired quality of life, increased amputation risk and even elevated death rates.
The United Nations, which passed a landmark resolution in December 2006 recognising diabetes as a chronic, debilitating and costly disease, has designated World Diabetes Day as an official United Nations Day for the first time in 2007.
And the World Health Organization has said that the number of people suffering from diabetes could double to 366 million by 2030 and that 80 per cent of diabetic foot amputations could be prevented.
A hundred patients aged 24 to 89 volunteered to take part in the shoe-size study carried out at a general diabetic clinic at Ninewells Hospital Medical School in Dundee, Scotland.
Patients who were also attending specialist foot clinics were excluded, as were patients who had problems standing or were wearing specially provided footwear.
"All the patients had their feet fully examined and measured while they were both sitting and standing" explains co-author Dr Graham Leese, a consultant at the clinic, which forms part of University of Dundee.
The team found that 63 per cent of the patients were wearing the wrong-sized shoes. For example, 45 per cent were wearing the wrong width fitting, with the majority being too narrow.
"When people stand up their feet change shape as the arch of the foot flattens and the foot becomes wider and longer" explains Dr Leese. "Taking both these sets of
measurements into account, only 37 per cent of the patients were actually wearing the right-sized shoes.
"Interestingly, patients who didn't have problems with lack of feeling in their feet a common problem with diabetes - were just as likely to wear badly fitting shoes as those who did.
"We also discovered that almost a third of the patients said they took a different shoe size to the one they were actually wearing. This isn't helped by the fact that shoe sizes vary from make to make."
45 per cent of the volunteers had experienced previous problems with their feet, including ulcers, callouses, bunions, corns or swelling. Despite this, 22 per cent never checked their own feet and only 29 per cent checked them daily.
Foot problems could be reduced by adults being offered foot-measuring services in shoe shops, say the researchers. They would also like to see manufacturers developing standardised shoe sizes and expanding the range of length and width fittings that they offer, especially for patients who have no feeling in their feet.
Podiatry expert Andrea Parnes, from the University of Ulster, agrees. She points out that, given the scale of the problem, it would make commercial sense for manufacturers to work with health professionals to expand their existing ranges.
In her accompanying editorial she calls for greater research into the problem, pointing out that the study also raises concerns about patients with conditions like rheumatoid arthritis.
The current issue of IJCP also includes a special supplement, which expresses support for the United Nation's resolution on diabetes and highlights practical examples that have been shown to improve diabetes care.
These range from raising government awareness worldwide to empowering patients at grassroots level.
BLACKWELL PUBLISHING LTD
9600 Garsington Road
Oxford OX4 2DQ
blackwellpublishing
Stem Cell Panel Headed By Utah Ethicist
University of Utah medical ethics expert Jeffrey R. Botkin will chair a federal panel that will review scientists' requests to conduct government-funded research using embryonic stem cells left over from couples who used "test-tube fertilization" to have babies.
"Stem cells have the capability of developing into any tissue type in the human body," says Botkin, a pediatrician and associate vice president for research integrity at the University of Utah. "If scientists can better understand the development of stem cells into different body tissues, then it may be possible to use stem cells to treat a wide variety of diseases that are caused by tissue aging, damage or degeneration."
"For example, if stem cells can be coaxed into developing into pancreas cells, it may be possible to use them to treat diabetes," he adds. "This is a very exciting area of biomedical research that offers great promise down the road."
Expanded use of cells from embryos left over from in vitro fertilization is made possible by an executive order signed March 9 by President Barack Obama. The order loosened the more restrictive policy under former President George W. Bush.
National Institutes of Health Director Francis S. Collins announced Monday his agency now is accepting requests for lines of human embryonic stem cells to be approved for use in NIH-funded research. Collins also named a new nine-member Working Group for Human Embryonic Stem Cell Eligibility Review, with Botkin as its chair.
Botkin - who also is chief of the University of Utah School of Medicine's Division of Medical Ethics and Humanities - says he was picked as chair due to his background in research ethics, and his past service on federal advisory committees, including one dealing with the protection of human subjects in research.
"Also, the fact that the University of Utah does not have an active program using human embryonic stem cells was probably a factor because this eliminated any conflicts of interest in that respect," Botkin says.
NIH guidelines published on July 7 and the new panel "will address which embryonic stem cell lines will be eligible for use in research supported by federal funds," he says. "These stem cell lines are created by taking cells from the inner cell mass of early-stage embryos. The process of extracting the cells from the inner cell mass destroys the embryo, which is, of course, the reason for the ethical debates over these cells since they were first successfully created in 1998."
Botkin emphasizes that under both the Bush and Obama guidelines, "it is not possible to use federal funds for the actual destruction of the embryos to create the stem cell lines. Rather, the guidelines address whether federal funds can be used for research using stem cells that were originally created using non-federal sources of funding."
Existing law and regulation allows private companies to conduct research that creates and uses human embryonic stem cells. But, says Botkin, "given the large amount of research funding provided by the federal government, the new guidelines will permit a significant increase in the number of projects using embryonic stem cells."
Botkin says "it is unclear" how many requests for approval the NIH will receive, although many researchers are eager to move forward with stem cell work.
"Under the previous policy formulated by the Bush administration, research with a limited number of stem cell lines was supported by the NIH," he says. "Only lines that were created before Aug. 9, 2001 (the date of the Bush policy announcement) were eligible for funding because the embryos had been destroyed already and the policy sought not to foster additional destruction of human embryos. However, the small number of available lines did not support many investigators who want to pursue this research, and questions were raised about the biological quality of some existing lines."
"Current estimates suggest there are hundreds of thousands of embryos that remain in fertility clinics from couples who created them for reproductive purposes," Botkin says. "Many of these couples have fulfilled their reproductive goals, meaning the leftover embryos will ultimately be discarded."
He says that under the Obama administration, the new NIH guidelines state "that these 'spare' embryos can be used for stem cell research if the couple who produced the embryos has given their full informed consent."
"For stem cells created after July 7, 2009, the guidelines are clear about the nature of the informed consent from couples who have 'spare' embryos," Botkin says. "The committee will not review proposed cell lines created after that date, although they will be reviewed administratively at the NIH. However, for lines created before July 7, 2009, review of the consent forms and the process by which the stem cells were created will be the responsibility of the committee."
He says the panel will ask, "Can we be assured that the couple fully understood their options, including use of their embryos in research, and agreed to the donation without any element of coercion or manipulation?"
Embryonic stem cell lines created in other nations often don't meet U.S. standards for informed consent, but the panel will ask whether the consent and process used to obtain the cells adequately fulfill the ethical principles in NIH guidelines. "If so, lines created internationally may be eligible for research using federal funds," Botkin says.
NIH Guidelines for Human Stem Cell Research may be found at: stemcells.nih/policy/2009guidelines.htm
"Stem cells have the capability of developing into any tissue type in the human body," says Botkin, a pediatrician and associate vice president for research integrity at the University of Utah. "If scientists can better understand the development of stem cells into different body tissues, then it may be possible to use stem cells to treat a wide variety of diseases that are caused by tissue aging, damage or degeneration."
"For example, if stem cells can be coaxed into developing into pancreas cells, it may be possible to use them to treat diabetes," he adds. "This is a very exciting area of biomedical research that offers great promise down the road."
Expanded use of cells from embryos left over from in vitro fertilization is made possible by an executive order signed March 9 by President Barack Obama. The order loosened the more restrictive policy under former President George W. Bush.
National Institutes of Health Director Francis S. Collins announced Monday his agency now is accepting requests for lines of human embryonic stem cells to be approved for use in NIH-funded research. Collins also named a new nine-member Working Group for Human Embryonic Stem Cell Eligibility Review, with Botkin as its chair.
Botkin - who also is chief of the University of Utah School of Medicine's Division of Medical Ethics and Humanities - says he was picked as chair due to his background in research ethics, and his past service on federal advisory committees, including one dealing with the protection of human subjects in research.
"Also, the fact that the University of Utah does not have an active program using human embryonic stem cells was probably a factor because this eliminated any conflicts of interest in that respect," Botkin says.
NIH guidelines published on July 7 and the new panel "will address which embryonic stem cell lines will be eligible for use in research supported by federal funds," he says. "These stem cell lines are created by taking cells from the inner cell mass of early-stage embryos. The process of extracting the cells from the inner cell mass destroys the embryo, which is, of course, the reason for the ethical debates over these cells since they were first successfully created in 1998."
Botkin emphasizes that under both the Bush and Obama guidelines, "it is not possible to use federal funds for the actual destruction of the embryos to create the stem cell lines. Rather, the guidelines address whether federal funds can be used for research using stem cells that were originally created using non-federal sources of funding."
Existing law and regulation allows private companies to conduct research that creates and uses human embryonic stem cells. But, says Botkin, "given the large amount of research funding provided by the federal government, the new guidelines will permit a significant increase in the number of projects using embryonic stem cells."
Botkin says "it is unclear" how many requests for approval the NIH will receive, although many researchers are eager to move forward with stem cell work.
"Under the previous policy formulated by the Bush administration, research with a limited number of stem cell lines was supported by the NIH," he says. "Only lines that were created before Aug. 9, 2001 (the date of the Bush policy announcement) were eligible for funding because the embryos had been destroyed already and the policy sought not to foster additional destruction of human embryos. However, the small number of available lines did not support many investigators who want to pursue this research, and questions were raised about the biological quality of some existing lines."
"Current estimates suggest there are hundreds of thousands of embryos that remain in fertility clinics from couples who created them for reproductive purposes," Botkin says. "Many of these couples have fulfilled their reproductive goals, meaning the leftover embryos will ultimately be discarded."
He says that under the Obama administration, the new NIH guidelines state "that these 'spare' embryos can be used for stem cell research if the couple who produced the embryos has given their full informed consent."
"For stem cells created after July 7, 2009, the guidelines are clear about the nature of the informed consent from couples who have 'spare' embryos," Botkin says. "The committee will not review proposed cell lines created after that date, although they will be reviewed administratively at the NIH. However, for lines created before July 7, 2009, review of the consent forms and the process by which the stem cells were created will be the responsibility of the committee."
He says the panel will ask, "Can we be assured that the couple fully understood their options, including use of their embryos in research, and agreed to the donation without any element of coercion or manipulation?"
Embryonic stem cell lines created in other nations often don't meet U.S. standards for informed consent, but the panel will ask whether the consent and process used to obtain the cells adequately fulfill the ethical principles in NIH guidelines. "If so, lines created internationally may be eligible for research using federal funds," Botkin says.
NIH Guidelines for Human Stem Cell Research may be found at: stemcells.nih/policy/2009guidelines.htm
Pancreatic Cells' Destruction In Diabetes - New Clues
Researchers have found what appears to be a major culprit behind the loss of insulin-producing ?? cells from the pancreases of people with diabetes, a critical event in the progression of the disease.
The discovery could lead to new therapies for preventing the death of ?? cells or restoring those that have already been lost, Kathrin Maedler and colleagues report in the February 4th issue of Cell Metabolism, a Cell Press publication. The inflammatory factor they uncovered, which they call CXCL10, might also offer a warning sign of early or impending disease, they said.
" Previously, the idea was that insulin resistance makes one diabetic, but loss of ?? cells occurs in both type 1 and type 2 diabetes," Maedler said, noting that among those who are insulin resistant, only 10-20 percent will go on to develop type 2 diabetes due to a failure of ?? cells. "We've found an inflammatory marker for both types of diabetes. If we can protect cells from CXCL10 expression, we might prevent the decline in ?? cell mass and, with it, the disease."
Type 1 diabetes is usually diagnosed in children or young adults and stems from an inability to produce insulin. The more common type 2 diabetes generally arises later in life when the body fails to produce enough insulin or grows unresponsive to the hormone.
In type 1 diabetes, ?? cells are known to be destroyed by the immune system and its production of high concentrations of inflammatory signals. While scientists had floated many ideas, exactly what causes ?? cell loss in type 2 diabetes remains a matter of debate.
Maedler's team suspected that inflammatory factors might play a key role there as well. Indeed, inflammatory markers are found in obesity, insulin resistance and diabetes, they explained. Earlier studies also showed that low-grade inflammation and activation of the innate immune system - the body's first line of defense - can lead to beta cell failure in type II diabetes.
They've now found that the inflammatory factor CXCL10 (also known as Interferon-gamma-inducible Protein-10, or IP-10) is an important trigger for ?? cells' destruction. They found that hormone-producing cells isolated from patients with type 2 diabetes secrete CXCL10 and contain more than 30 times the amount of the CXCL10 message in the form of RNA than do cells from patients without diabetes.
Pancreatic sections taken from obese people without diabetes as well as those with type 1 or type 2 diabetes showed CXCL10 in the ?? cells, they found. Moreover, treatment of isolated human pancreatic cells with CXCL10 decreased ?? cell viability and impaired the production and secretion of insulin. They traced those effects of CXCL10 to a well-known pathway of the innate immune system involving a protein known as toll-like receptor 4 (TLR4).
The new data suggest a potential mechanism for the switch from ?? cells' proliferation to their programmed cell death, the researchers concluded. "To prevent such a progression using anti-inflammatory targets of the TLR4 signaling pathway will be of high importance to rescue the ?? cell from inflammation-induced self-destruction and [to] preserve ?? cell function and mass."
The researchers include Fabienne T. Schulthess, University of California, Los Angeles, Los Angeles, CA, University of Bremen, Bremen, Germany; Federico Paroni, University of Bremen, Bremen, Germany; Nadine S. Sauter, University of California, Los Angeles, Los Angeles, CA; Luan Shu, University of California, Los Angeles, Los Angeles, CA, University of Bremen, Bremen, Germany; Pascale Ribaux, University Medical Center, Geneva, Switzerland; Leena Haataja, University of California, Los Angeles, Los Angeles, CA, Robert M. Strieter, University of Virginia School of Medicine, Charlottesville, VA; Jose Oberholzer, University of Illinois at Chicago, Chicago, IL; Charles C. King, University of California, San Diego, La Jolla, CA; and Kathrin Maedler, University of California, Los Angeles, Los Angeles, CA, University of Bremen, Bremen, Germany.
The discovery could lead to new therapies for preventing the death of ?? cells or restoring those that have already been lost, Kathrin Maedler and colleagues report in the February 4th issue of Cell Metabolism, a Cell Press publication. The inflammatory factor they uncovered, which they call CXCL10, might also offer a warning sign of early or impending disease, they said.
" Previously, the idea was that insulin resistance makes one diabetic, but loss of ?? cells occurs in both type 1 and type 2 diabetes," Maedler said, noting that among those who are insulin resistant, only 10-20 percent will go on to develop type 2 diabetes due to a failure of ?? cells. "We've found an inflammatory marker for both types of diabetes. If we can protect cells from CXCL10 expression, we might prevent the decline in ?? cell mass and, with it, the disease."
Type 1 diabetes is usually diagnosed in children or young adults and stems from an inability to produce insulin. The more common type 2 diabetes generally arises later in life when the body fails to produce enough insulin or grows unresponsive to the hormone.
In type 1 diabetes, ?? cells are known to be destroyed by the immune system and its production of high concentrations of inflammatory signals. While scientists had floated many ideas, exactly what causes ?? cell loss in type 2 diabetes remains a matter of debate.
Maedler's team suspected that inflammatory factors might play a key role there as well. Indeed, inflammatory markers are found in obesity, insulin resistance and diabetes, they explained. Earlier studies also showed that low-grade inflammation and activation of the innate immune system - the body's first line of defense - can lead to beta cell failure in type II diabetes.
They've now found that the inflammatory factor CXCL10 (also known as Interferon-gamma-inducible Protein-10, or IP-10) is an important trigger for ?? cells' destruction. They found that hormone-producing cells isolated from patients with type 2 diabetes secrete CXCL10 and contain more than 30 times the amount of the CXCL10 message in the form of RNA than do cells from patients without diabetes.
Pancreatic sections taken from obese people without diabetes as well as those with type 1 or type 2 diabetes showed CXCL10 in the ?? cells, they found. Moreover, treatment of isolated human pancreatic cells with CXCL10 decreased ?? cell viability and impaired the production and secretion of insulin. They traced those effects of CXCL10 to a well-known pathway of the innate immune system involving a protein known as toll-like receptor 4 (TLR4).
The new data suggest a potential mechanism for the switch from ?? cells' proliferation to their programmed cell death, the researchers concluded. "To prevent such a progression using anti-inflammatory targets of the TLR4 signaling pathway will be of high importance to rescue the ?? cell from inflammation-induced self-destruction and [to] preserve ?? cell function and mass."
The researchers include Fabienne T. Schulthess, University of California, Los Angeles, Los Angeles, CA, University of Bremen, Bremen, Germany; Federico Paroni, University of Bremen, Bremen, Germany; Nadine S. Sauter, University of California, Los Angeles, Los Angeles, CA; Luan Shu, University of California, Los Angeles, Los Angeles, CA, University of Bremen, Bremen, Germany; Pascale Ribaux, University Medical Center, Geneva, Switzerland; Leena Haataja, University of California, Los Angeles, Los Angeles, CA, Robert M. Strieter, University of Virginia School of Medicine, Charlottesville, VA; Jose Oberholzer, University of Illinois at Chicago, Chicago, IL; Charles C. King, University of California, San Diego, La Jolla, CA; and Kathrin Maedler, University of California, Los Angeles, Los Angeles, CA, University of Bremen, Bremen, Germany.
African Americans Have 5 Times Higher Amputation Rate
The overall amputation rate in northern Illinois is declining due to improved care for diabetes and peripheral vascular disease, new research shows.
But not everyone is reaping the benefits.
A new study from Northwestern University's Feinberg School of Medicine has found people in African American communities on Chicago's South and West Side have a five times higher rate of lower limb amputations than people in the predominantly white suburbs and exurbs.
"Amputations are the canary in the coal mine for quality of care," said Joe Feinglass, lead author and research professor of medicine at the Feinberg School. "Many amputations are preventable. This means the primary care for minority people may not be very good. "
Feinglass said the high rate of amputations means people are not being closely monitored. "They come in with gangrene or a skin ulcer that comes to the attention of a doctor really late and nothing can be done," he said. "They have to take their leg off."
This is the first longitudinal study -- nationally or locally -- to examine amputation trends over nearly 20 years. Most studies of amputation rates look at one point in time.
The study will be published in the May issue of the Journal of Vascular Surgery.
The high amputation rate for minorities in Chicago likely reflects other racial disparities in healthcare, Feinglass said. "Diabetes is a condition that is highly susceptible to quality of care. Amputation rates give you a basic idea of how the system is performing."
It was known in the late 1990's that African Americans were more likely to have an amputation than whites. But as the national trend of amputations declined in the early 2000's, Feinglass wanted to see if the gap closed or at least narrowed.
The study examined hospital discharge data from the Illinois Department of Public Health for nine counties in northern Illinois encompassing more than eight million people. Feinglass then broke the statistics into three rings of the metropolitan area based on their zip codes.
He found that amputations in the suburban and exurban areas with a primarily white population dropped to 12 per 100,000 in 2004 from 14 in 1987. The largely African American area on the South and West Side actually increased to 63 amputations from 60. The inner suburbs and other areas of Chicago, with between 10 and 50 percent African American population and a large Hispanic population, held fairly steady at 20 amputations per 100,000.
About half of the people who have amputations are diabetic patients with decreased circulation to the feet. Almost all who have amputations are smokers, a habit that can cause hardening of the arteries and clots in the legs.
"These people get sores on their feet that don't heal," Feinglass said. "They develop an ulcer that can often turn into something worse if it's not treated right away."
The high amputation rate is linked to lack of access to primary care and specialty care for diabetic patients and patients with vascular disease. In addition, patients without diabetes may not get a screening for peripheral arterial disease, an inexpensive test to indicate risk factors for circulation problems.
To address these problems, Feinglass said communities need diabetes management programs with nurses to help people control their blood sugar.
"Those are the kinds of programs we know would pay off in the inner city. When blood sugar is lower, there is a lower amputation rate," Feinglass said. Vascular surgeons and podiatrists are also needed in these areas.
"An amputation is a horrible thing to have anybody go through," Feinglass said. "We have to do better at preventing these."
But not everyone is reaping the benefits.
A new study from Northwestern University's Feinberg School of Medicine has found people in African American communities on Chicago's South and West Side have a five times higher rate of lower limb amputations than people in the predominantly white suburbs and exurbs.
"Amputations are the canary in the coal mine for quality of care," said Joe Feinglass, lead author and research professor of medicine at the Feinberg School. "Many amputations are preventable. This means the primary care for minority people may not be very good. "
Feinglass said the high rate of amputations means people are not being closely monitored. "They come in with gangrene or a skin ulcer that comes to the attention of a doctor really late and nothing can be done," he said. "They have to take their leg off."
This is the first longitudinal study -- nationally or locally -- to examine amputation trends over nearly 20 years. Most studies of amputation rates look at one point in time.
The study will be published in the May issue of the Journal of Vascular Surgery.
The high amputation rate for minorities in Chicago likely reflects other racial disparities in healthcare, Feinglass said. "Diabetes is a condition that is highly susceptible to quality of care. Amputation rates give you a basic idea of how the system is performing."
It was known in the late 1990's that African Americans were more likely to have an amputation than whites. But as the national trend of amputations declined in the early 2000's, Feinglass wanted to see if the gap closed or at least narrowed.
The study examined hospital discharge data from the Illinois Department of Public Health for nine counties in northern Illinois encompassing more than eight million people. Feinglass then broke the statistics into three rings of the metropolitan area based on their zip codes.
He found that amputations in the suburban and exurban areas with a primarily white population dropped to 12 per 100,000 in 2004 from 14 in 1987. The largely African American area on the South and West Side actually increased to 63 amputations from 60. The inner suburbs and other areas of Chicago, with between 10 and 50 percent African American population and a large Hispanic population, held fairly steady at 20 amputations per 100,000.
About half of the people who have amputations are diabetic patients with decreased circulation to the feet. Almost all who have amputations are smokers, a habit that can cause hardening of the arteries and clots in the legs.
"These people get sores on their feet that don't heal," Feinglass said. "They develop an ulcer that can often turn into something worse if it's not treated right away."
The high amputation rate is linked to lack of access to primary care and specialty care for diabetic patients and patients with vascular disease. In addition, patients without diabetes may not get a screening for peripheral arterial disease, an inexpensive test to indicate risk factors for circulation problems.
To address these problems, Feinglass said communities need diabetes management programs with nurses to help people control their blood sugar.
"Those are the kinds of programs we know would pay off in the inner city. When blood sugar is lower, there is a lower amputation rate," Feinglass said. Vascular surgeons and podiatrists are also needed in these areas.
"An amputation is a horrible thing to have anybody go through," Feinglass said. "We have to do better at preventing these."
Lexicon Presents Data Describing LX4211 Positive Phase 2 Clinical Results And Novel Mechanism Of Action For Type 2 Diabetes
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, presented clinical data and analysis from its Phase 2a clinical trial of LX4211 for patients with type 2 diabetes mellitus at ENDO 2010 today. The results reported today included newly-obtained data showing a trend of increased total GLP-1 in both LX4211 treatment arms relative to placebo as measured in a post-trial analysis of blood samples.
The Phase 2a clinical trial demonstrated that administration of LX4211, a dual SGLT2 and SGLT1 inhibitor, produced rapid and significant improvement in multiple assessments of glycemic control as well as positive trends in cardiovascular and metabolic parameters after only 28 days of dosing in type 2 diabetes patients. Importantly, after only four weeks of dosing, average percent hemoglobin A1c (HbA1c), a measure of blood glucose levels over time, was significantly reduced by 1.15 in the 150 mg dose group (p=0.036) and by 1.25 in the 300 mg dose group (p=0.017), as compared with 0.49 in the placebo group. HbA1c levels were reduced to less than or equal to 7% for half the patients in both dose groups; baseline levels were 8.22%, 8.50% and 8.20% for the 150 mg, 300 mg and placebo groups, respectively. In addition, positive trends were observed in weight, blood pressure and triglyceride reduction.
"The increases observed in total GLP-1 levels among type 2 diabetes patients randomized to LX4211 are consistent with what might be expected from SGLT1 inhibition in the small intestine stimulating the endogenous incretin pathway," commented Brian Zambrowicz, Ph.D., Lexicon's executive vice president and chief scientific officer. "We believe the unique-in-class SGLT1 activity synergizes with SGLT2 inhibition to produce the rapid and robust glycemic control observed with this compound in our Phase 2a study."
LX4211 is an orally-delivered small molecule under development as a potential treatment for diabetes. LX4211 inhibits both sodium-glucose cotransporter type 2, or SGLT2, and sodium-glucose cotransporter type 1, or SGLT1. SGLT2 is a transporter responsible for most of the glucose reabsorption performed by the kidney. SGLT1 is a transporter responsible for glucose and galactose absorption in the gastrointestinal tract, and to a lesser extent than SGLT2, glucose reabsorption in the kidney.
About Lexicon
Lexicon is a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease. Lexicon currently has four drug candidates in mid-stage development for diabetes, irritable bowel syndrome, carcinoid syndrome and rheumatoid arthritis, all of which were discovered by Lexicon's research team. Lexicon has used its proprietary gene knockout technology to identify more than 100 promising drug targets. Lexicon has focused drug discovery efforts on these biologically-validated targets to create its extensive pipeline of clinical and preclinical programs.
Safe Harbor Statement
This press release contains "forward-looking statements," including statements relating to the characterization of the safety and efficacy profile of LX4211 observed in the Phase 2 clinical trial as positive or favorable, the characterization of the results of the Phase 2 clinical trial of LX4211 as demonstrating the potential for a therapeutic benefit for patients with type 2 diabetes, the mechanism of action of LX4211, and the potential therapeutic and commercial potential of LX4211 generally. This press release also contains forward-looking statements relating to Lexicon's growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Lexicon's ability to successfully conduct clinical development of LX4211 and preclinical and clinical development of its other potential drug candidates, advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Factors Affecting Forward-Looking Statements" and "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2009, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
The Phase 2a clinical trial demonstrated that administration of LX4211, a dual SGLT2 and SGLT1 inhibitor, produced rapid and significant improvement in multiple assessments of glycemic control as well as positive trends in cardiovascular and metabolic parameters after only 28 days of dosing in type 2 diabetes patients. Importantly, after only four weeks of dosing, average percent hemoglobin A1c (HbA1c), a measure of blood glucose levels over time, was significantly reduced by 1.15 in the 150 mg dose group (p=0.036) and by 1.25 in the 300 mg dose group (p=0.017), as compared with 0.49 in the placebo group. HbA1c levels were reduced to less than or equal to 7% for half the patients in both dose groups; baseline levels were 8.22%, 8.50% and 8.20% for the 150 mg, 300 mg and placebo groups, respectively. In addition, positive trends were observed in weight, blood pressure and triglyceride reduction.
"The increases observed in total GLP-1 levels among type 2 diabetes patients randomized to LX4211 are consistent with what might be expected from SGLT1 inhibition in the small intestine stimulating the endogenous incretin pathway," commented Brian Zambrowicz, Ph.D., Lexicon's executive vice president and chief scientific officer. "We believe the unique-in-class SGLT1 activity synergizes with SGLT2 inhibition to produce the rapid and robust glycemic control observed with this compound in our Phase 2a study."
LX4211 is an orally-delivered small molecule under development as a potential treatment for diabetes. LX4211 inhibits both sodium-glucose cotransporter type 2, or SGLT2, and sodium-glucose cotransporter type 1, or SGLT1. SGLT2 is a transporter responsible for most of the glucose reabsorption performed by the kidney. SGLT1 is a transporter responsible for glucose and galactose absorption in the gastrointestinal tract, and to a lesser extent than SGLT2, glucose reabsorption in the kidney.
About Lexicon
Lexicon is a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease. Lexicon currently has four drug candidates in mid-stage development for diabetes, irritable bowel syndrome, carcinoid syndrome and rheumatoid arthritis, all of which were discovered by Lexicon's research team. Lexicon has used its proprietary gene knockout technology to identify more than 100 promising drug targets. Lexicon has focused drug discovery efforts on these biologically-validated targets to create its extensive pipeline of clinical and preclinical programs.
Safe Harbor Statement
This press release contains "forward-looking statements," including statements relating to the characterization of the safety and efficacy profile of LX4211 observed in the Phase 2 clinical trial as positive or favorable, the characterization of the results of the Phase 2 clinical trial of LX4211 as demonstrating the potential for a therapeutic benefit for patients with type 2 diabetes, the mechanism of action of LX4211, and the potential therapeutic and commercial potential of LX4211 generally. This press release also contains forward-looking statements relating to Lexicon's growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Lexicon's ability to successfully conduct clinical development of LX4211 and preclinical and clinical development of its other potential drug candidates, advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Factors Affecting Forward-Looking Statements" and "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2009, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
Minority Groups Pick Up Worst European Eating Habits
Immigrant populations in Europe face an increased risk of diet-related diseases as they adjust to a 'Western' lifestyle, according to scientists at the University of Leeds.
A recent study shows that the dietary habits of immigrants change when they move to European countries. According to the research, immigrant populations replace the healthy components of their native diet with the worst aspects of western diets, such as processed and fast foods.
The risks are greater among younger generations of the immigrant groups, as they are more likely than their elders to eat less healthy foods found in their new country.
Dr Santosh Khokhar at the University of Leeds' School of Food Science and Nutrition examined changes to the diets of African-Caribbeans, Chinese, Mexicans, Moroccans, Surinamese, South Asians and Turks living in Europe.
They found ethnic groups with low incomes had the most restricted food choice, as the foods of their traditional diet had to be imported, so becoming more expensive. In comparison, the availability of the unhealthiest western food was very high and also low cost.
Dr Khokhar, Senior Lecturer in Food Biochemistry, said that elements of the traditional diets are being 'replaced' with less healthy alternatives'. She continued: "The inclusion of snack foods such as French fries, chips and cakes leads to ethnic populations having higher levels of fat, salt and sugar in their diet."
She added that groups in lower socioeconomic communities "often eat poorer quality foods, such as cheaper cuts of meat with more fat. They also tend to buy less fruits and vegetables and they consume more processed foods".
In the study Changing dietary habits of ethnic groups in Europe and implications for health, published in Nutrition Reviews, she proposed that the decline in the nutritional quality of the diet leads to ethnic groups becoming "more susceptible to diet-related health problems similar to those affecting the mainstream population in Europe, such as obesity, cardiovascular disease, and diabetes".
"The ethnic group that integrated most strongly with their host country rapidly adopted the disease patterns of the host," she said.
The study found that diets are affected by a variety of factors including income, a lack of nutritional knowledge, availability of certain foods and the religious customs of the ethnic group. Generation and age are also major factors; younger generations have a less traditional diet compared to their elders, who tend to be "more segregated from the mainstream population and thus continue eating traditional foods."
In related research published in the journal Food Chemistry, Dr Khokhar emphasised that to fully understand the impact of diet on health more information is needed on the composition of individual foods and of the diet as a whole. It is particularly important to produce data using agreed ['harmonised'] procedures so that comparisons can be made between countries and between populations.
Dr Khokhar's research was funded by the European Commission under the EU's 6th Framework Programme's Food Quality and Safety theme and was part of the EuroFIR consortium which is developing an international food composition information system.
P A Gilbert and S Khokhar, Changing dietary habits of ethnic groups in Europe and implications for health, Nutrition Reviews, 2008, 66 (4).
S Khokhar et al., Harmonised procedures for producing new data on the nutritional composition of ethnic foods, Food Chemistry, 2009, 113, 816-24
A recent study shows that the dietary habits of immigrants change when they move to European countries. According to the research, immigrant populations replace the healthy components of their native diet with the worst aspects of western diets, such as processed and fast foods.
The risks are greater among younger generations of the immigrant groups, as they are more likely than their elders to eat less healthy foods found in their new country.
Dr Santosh Khokhar at the University of Leeds' School of Food Science and Nutrition examined changes to the diets of African-Caribbeans, Chinese, Mexicans, Moroccans, Surinamese, South Asians and Turks living in Europe.
They found ethnic groups with low incomes had the most restricted food choice, as the foods of their traditional diet had to be imported, so becoming more expensive. In comparison, the availability of the unhealthiest western food was very high and also low cost.
Dr Khokhar, Senior Lecturer in Food Biochemistry, said that elements of the traditional diets are being 'replaced' with less healthy alternatives'. She continued: "The inclusion of snack foods such as French fries, chips and cakes leads to ethnic populations having higher levels of fat, salt and sugar in their diet."
She added that groups in lower socioeconomic communities "often eat poorer quality foods, such as cheaper cuts of meat with more fat. They also tend to buy less fruits and vegetables and they consume more processed foods".
In the study Changing dietary habits of ethnic groups in Europe and implications for health, published in Nutrition Reviews, she proposed that the decline in the nutritional quality of the diet leads to ethnic groups becoming "more susceptible to diet-related health problems similar to those affecting the mainstream population in Europe, such as obesity, cardiovascular disease, and diabetes".
"The ethnic group that integrated most strongly with their host country rapidly adopted the disease patterns of the host," she said.
The study found that diets are affected by a variety of factors including income, a lack of nutritional knowledge, availability of certain foods and the religious customs of the ethnic group. Generation and age are also major factors; younger generations have a less traditional diet compared to their elders, who tend to be "more segregated from the mainstream population and thus continue eating traditional foods."
In related research published in the journal Food Chemistry, Dr Khokhar emphasised that to fully understand the impact of diet on health more information is needed on the composition of individual foods and of the diet as a whole. It is particularly important to produce data using agreed ['harmonised'] procedures so that comparisons can be made between countries and between populations.
Dr Khokhar's research was funded by the European Commission under the EU's 6th Framework Programme's Food Quality and Safety theme and was part of the EuroFIR consortium which is developing an international food composition information system.
P A Gilbert and S Khokhar, Changing dietary habits of ethnic groups in Europe and implications for health, Nutrition Reviews, 2008, 66 (4).
S Khokhar et al., Harmonised procedures for producing new data on the nutritional composition of ethnic foods, Food Chemistry, 2009, 113, 816-24
Diabetes And Heart Disease: Risk Intertwined
What's the most common long-term complication of diabetes? Problems with the heart and blood vessels, according to the February issue of Mayo Clinic Women's HealthSource.
Cardiovascular diseases, including heart attack and stroke, account for 65 percent of all diabetes-related deaths. People with diabetes are two to four times more likely to have a heart attack than is someone without the disease. For a middle-aged person with type 2 diabetes, the risk of a future heart attack is the same as that of someone who's already had a heart attack. Also attention getting: when people with diabetes have heart attacks, they are more serious and more likely to result in death than in adults without diabetes.
People with diabetes are at higher risk of cardiovascular disease because too much blood sugar (glucose) can lead to damage inside blood vessel walls. This damage makes it easier for fatty deposits (plaques) to form in arteries and cause narrowing or blockages that can lead to heart attacks or strokes.
Having diabetes doesn't mean heart disease is inevitable. Optimal control over the ABCs of diabetes, as suggested by the American Diabetes Association, can reduce heart disease risk. The ABCs are:
A1C: The best way to measure blood glucose levels over time is the glycoslyated hemoglobin A1C test. This blood test, given by a physician, reflects average blood sugar control over three months. The ADA recommends maintaining the A1C level at less than 7 percent. New research has indicated that intensive measures required to get below 7 percent might not offer cardiovascular benefits. A physician can determine the best goal for the A1C level. The test is recommended at least twice a year.
Blood pressure: High blood pressure is a common partner to diabetes. For people with diabetes, an ideal reading is below 130/80 millimeters of mercury (mm Hg).
Cholesterol levels: The optimal target is less than 100 milligrams per deciliter (mg/dL) for low-density lipoprotein (LDL) cholesterol. For high-density lipoprotein (HDL) cholesterol, the recommended level is more than 50 mg/dL for women and more than 40 mg/dL for men.
A physician can help with a treatment plan to meet these guidelines. A healthy diet, regular physical activity, weight loss, smoking cessation and limited alcohol consumption all are beneficial. Medications also may be needed. For example, research has shown that most adults with high blood pressure and diabetes require multiple drug therapies to reach blood pressure goals.
The bottom line: Risks and complications from diabetes and heart disease are intertwined. People with diabetes who manage heart disease risks can help avoid life-threatening complications.
Mayo Clinic
200 First St. SW
Rochester
MN 55902
United States
mayoclinic
Cardiovascular diseases, including heart attack and stroke, account for 65 percent of all diabetes-related deaths. People with diabetes are two to four times more likely to have a heart attack than is someone without the disease. For a middle-aged person with type 2 diabetes, the risk of a future heart attack is the same as that of someone who's already had a heart attack. Also attention getting: when people with diabetes have heart attacks, they are more serious and more likely to result in death than in adults without diabetes.
People with diabetes are at higher risk of cardiovascular disease because too much blood sugar (glucose) can lead to damage inside blood vessel walls. This damage makes it easier for fatty deposits (plaques) to form in arteries and cause narrowing or blockages that can lead to heart attacks or strokes.
Having diabetes doesn't mean heart disease is inevitable. Optimal control over the ABCs of diabetes, as suggested by the American Diabetes Association, can reduce heart disease risk. The ABCs are:
A1C: The best way to measure blood glucose levels over time is the glycoslyated hemoglobin A1C test. This blood test, given by a physician, reflects average blood sugar control over three months. The ADA recommends maintaining the A1C level at less than 7 percent. New research has indicated that intensive measures required to get below 7 percent might not offer cardiovascular benefits. A physician can determine the best goal for the A1C level. The test is recommended at least twice a year.
Blood pressure: High blood pressure is a common partner to diabetes. For people with diabetes, an ideal reading is below 130/80 millimeters of mercury (mm Hg).
Cholesterol levels: The optimal target is less than 100 milligrams per deciliter (mg/dL) for low-density lipoprotein (LDL) cholesterol. For high-density lipoprotein (HDL) cholesterol, the recommended level is more than 50 mg/dL for women and more than 40 mg/dL for men.
A physician can help with a treatment plan to meet these guidelines. A healthy diet, regular physical activity, weight loss, smoking cessation and limited alcohol consumption all are beneficial. Medications also may be needed. For example, research has shown that most adults with high blood pressure and diabetes require multiple drug therapies to reach blood pressure goals.
The bottom line: Risks and complications from diabetes and heart disease are intertwined. People with diabetes who manage heart disease risks can help avoid life-threatening complications.
Mayo Clinic
200 First St. SW
Rochester
MN 55902
United States
mayoclinic
Women With Type 1 Diabetes Receive No Heart Benefit From Omega-3
Consuming higher amounts of omega-3 fatty acids does not appear to lower heart disease risk for women with type 1 diabetes, according to a University of Pittsburgh Graduate School of Public Health study presented at the 70th Scientific Sessions of the American Diabetes Association.
The study, abstract number 1757-P, included 601 men and women enrolled in the Pittsburgh Epidemiology of Diabetes Complications Study, a long-term prospective examination of childhood onset type 1 diabetes that began in 1986. Participants were diagnosed with type 1 diabetes between 1950 and 1980.
Omega-3 fatty acids, primarily found in fish, promote heart health by preventing the buildup of cholesterol in the arteries. Little is known about the effect of consuming omega-3 in people with type 1 diabetes, who are at much greater risk for heart disease.
During the course of the study, 166 participants (27.6 percent) were diagnosed with cardiovascular disease. Generally, omega-3 intake among participants was low. The incidence of heart disease was lowest in men who consumed the highest quantities of omega-3 - more than 0.2 grams per day. Women who consumed similar amounts of omega-3 did not have lower rates of heart disease.
"Although omega-3 is typically associated with decreased risk for cardiovascular disease, this may not be the case for women who have type 1 diabetes," said Tina Costacou, Ph.D., lead author of the study and assistant professor of epidemiology, University of Pittsburgh Graduate School of Public Health. "Importantly, our study suggests we shouldn't assume men and women with type 1 diabetes are the same."
Study co-authors include Cathy E. Lloyd, Ph.D., and Trevor Orchard, M.D., of the University of Pittsburgh. The study was funded by the National Institutes of Health.
The study, abstract number 1757-P, included 601 men and women enrolled in the Pittsburgh Epidemiology of Diabetes Complications Study, a long-term prospective examination of childhood onset type 1 diabetes that began in 1986. Participants were diagnosed with type 1 diabetes between 1950 and 1980.
Omega-3 fatty acids, primarily found in fish, promote heart health by preventing the buildup of cholesterol in the arteries. Little is known about the effect of consuming omega-3 in people with type 1 diabetes, who are at much greater risk for heart disease.
During the course of the study, 166 participants (27.6 percent) were diagnosed with cardiovascular disease. Generally, omega-3 intake among participants was low. The incidence of heart disease was lowest in men who consumed the highest quantities of omega-3 - more than 0.2 grams per day. Women who consumed similar amounts of omega-3 did not have lower rates of heart disease.
"Although omega-3 is typically associated with decreased risk for cardiovascular disease, this may not be the case for women who have type 1 diabetes," said Tina Costacou, Ph.D., lead author of the study and assistant professor of epidemiology, University of Pittsburgh Graduate School of Public Health. "Importantly, our study suggests we shouldn't assume men and women with type 1 diabetes are the same."
Study co-authors include Cathy E. Lloyd, Ph.D., and Trevor Orchard, M.D., of the University of Pittsburgh. The study was funded by the National Institutes of Health.
FDA Approves Freestyle Connect(R) Blood Glucose Monitoring System, Abbott
Abbott Diabetes Care, a division of Abbott, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its FreeStyle Connect(R) blood glucose monitoring system in the point-of-care setting (hospitals and medical clinics).
FreeStyle Connect measures glucose levels using a very small blood sample size (0.3 micro liter), the smallest sample size required of any point-of-care blood glucose monitoring product on the market. It is the also the fastest point-of-care blood glucose monitoring system available, providing results within an average of 15 seconds. The advanced technology employed by FreeStyle Connect ensures reliable results under real-world conditions, with accuracy independent of blood oxygen levels. Further, results are not affected by many common substances such as aspirin, acetaminophen, gentisic acid, uric acid, vitamins, and many over-the-counter drugs. FreeStyle Connect is also designed to seamlessly interface with any open point-of-care data management system.
"Studies have demonstrated that FreeStyle Connect provides accurate results using a very small sample size which may offer advantages with challenging arterial and neonatal samples. In addition, it may save nursing time, which is a key benefit in a busy hospital," said George Cembrowski, M.D., Ph.D, Associate Professor, Laboratory Medicine and Pathology, University of Alberta, Edmonton, Alberta.
FreeStyle Connect uses a technology exclusive to all FreeStyle(R) meters based on coulometric measurement. This unique, patented, electrochemical technology measures virtually all of the available glucose in the blood sample, making it ideal for measuring a small sample size. Coulometric technology has already been used by people with diabetes worldwide in more than two billion blood glucose tests using FreeStyle(R) blood glucose strips.
"FreeStyle Connect is an exciting advance for blood glucose monitoring in the point-of-care setting, offering outstanding accuracy. FreeStyle Connect also provides improved convenience and ease-of-use for clinicians and hospital staff," said Ed Fiorentino, President, Abbott Diabetes Care.
The accuracy of the FreeStyle Connect blood glucose monitoring system has been tested in three clinical studies1,2,3. Two studies conducted at Duke University Medical Center and Hartford Hospital, examined nearly 300 arterial blood samples comparing FreeStyle Connect to three laboratory analyzers. The Duke study found that FreeStyle Connect provided accurate, rapid results on a very small volume of blood in the point-of-care setting. The Hartford researchers concluded that FreeStyle Connect results were consistent with laboratory assays and were not affected by hemoglobin and oxygen in the arterial blood samples.1,2
The third study, conducted at Washington University School of Medicine, evaluated the accuracy of FreeStyle Connect in 194 blood samples from neonates less than 10 days old. The results demonstrated accuracy as compared to the laboratory method. The researchers also found this monitoring system useful in neonates due to the very small blood sample required for testing.3
FreeStyle Connect blood glucose monitoring systems will be available in August, 2005.
About Abbott Diabetes Care
Abbott Diabetes Care, based in Alameda, California, is a leader in developing, manufacturing and marketing glucose monitoring systems designed to help patients better manage their diabetes. Abbott Diabetes Care is committed to developing products to reduce the discomfort and inconvenience of blood glucose monitoring and introducing systems that are easier to use, require smaller blood samples and provide faster results.
Abbott Diabetes Care manufactures and markets several leading-edge glucose monitoring systems and test strips in the United States for use in both home and hospital settings; leading brands include FreeStyle,(R) FreeStyle Flash(R), and Precision Xtra.(R) Additional information about Abbott Diabetes Care can be found at abbottdiabetescare.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 60,000 people and markets its products in more than 130 countries.
1 Toffaletti, J, McDonnell E. Evaluation of a coulometric hand-held blood glucose monitoring device. Duke University Medical Center.
2 Wu A, Smith A. Arterial blood testing using the FreeStyle Blood Glucose Monitoring System. Hartford Hospital.
3 Dietzen, DJ, Wilhite TR, Accuracy of near-patient glucose analysis using coulometry in neonates. Department of Pediatrics, Washington University School of Medicine, St. Louis Children's Hospital.
abbottdiabetescare
FreeStyle Connect measures glucose levels using a very small blood sample size (0.3 micro liter), the smallest sample size required of any point-of-care blood glucose monitoring product on the market. It is the also the fastest point-of-care blood glucose monitoring system available, providing results within an average of 15 seconds. The advanced technology employed by FreeStyle Connect ensures reliable results under real-world conditions, with accuracy independent of blood oxygen levels. Further, results are not affected by many common substances such as aspirin, acetaminophen, gentisic acid, uric acid, vitamins, and many over-the-counter drugs. FreeStyle Connect is also designed to seamlessly interface with any open point-of-care data management system.
"Studies have demonstrated that FreeStyle Connect provides accurate results using a very small sample size which may offer advantages with challenging arterial and neonatal samples. In addition, it may save nursing time, which is a key benefit in a busy hospital," said George Cembrowski, M.D., Ph.D, Associate Professor, Laboratory Medicine and Pathology, University of Alberta, Edmonton, Alberta.
FreeStyle Connect uses a technology exclusive to all FreeStyle(R) meters based on coulometric measurement. This unique, patented, electrochemical technology measures virtually all of the available glucose in the blood sample, making it ideal for measuring a small sample size. Coulometric technology has already been used by people with diabetes worldwide in more than two billion blood glucose tests using FreeStyle(R) blood glucose strips.
"FreeStyle Connect is an exciting advance for blood glucose monitoring in the point-of-care setting, offering outstanding accuracy. FreeStyle Connect also provides improved convenience and ease-of-use for clinicians and hospital staff," said Ed Fiorentino, President, Abbott Diabetes Care.
The accuracy of the FreeStyle Connect blood glucose monitoring system has been tested in three clinical studies1,2,3. Two studies conducted at Duke University Medical Center and Hartford Hospital, examined nearly 300 arterial blood samples comparing FreeStyle Connect to three laboratory analyzers. The Duke study found that FreeStyle Connect provided accurate, rapid results on a very small volume of blood in the point-of-care setting. The Hartford researchers concluded that FreeStyle Connect results were consistent with laboratory assays and were not affected by hemoglobin and oxygen in the arterial blood samples.1,2
The third study, conducted at Washington University School of Medicine, evaluated the accuracy of FreeStyle Connect in 194 blood samples from neonates less than 10 days old. The results demonstrated accuracy as compared to the laboratory method. The researchers also found this monitoring system useful in neonates due to the very small blood sample required for testing.3
FreeStyle Connect blood glucose monitoring systems will be available in August, 2005.
About Abbott Diabetes Care
Abbott Diabetes Care, based in Alameda, California, is a leader in developing, manufacturing and marketing glucose monitoring systems designed to help patients better manage their diabetes. Abbott Diabetes Care is committed to developing products to reduce the discomfort and inconvenience of blood glucose monitoring and introducing systems that are easier to use, require smaller blood samples and provide faster results.
Abbott Diabetes Care manufactures and markets several leading-edge glucose monitoring systems and test strips in the United States for use in both home and hospital settings; leading brands include FreeStyle,(R) FreeStyle Flash(R), and Precision Xtra.(R) Additional information about Abbott Diabetes Care can be found at abbottdiabetescare.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 60,000 people and markets its products in more than 130 countries.
1 Toffaletti, J, McDonnell E. Evaluation of a coulometric hand-held blood glucose monitoring device. Duke University Medical Center.
2 Wu A, Smith A. Arterial blood testing using the FreeStyle Blood Glucose Monitoring System. Hartford Hospital.
3 Dietzen, DJ, Wilhite TR, Accuracy of near-patient glucose analysis using coulometry in neonates. Department of Pediatrics, Washington University School of Medicine, St. Louis Children's Hospital.
abbottdiabetescare
Protein Has Pivotal Role In Obesity, Metabolic Syndrome
A protein known to play a role in development and the formation of organs is also an important factor in the control of obesity and diabetes, said researchers from Baylor College of Medicine in a report that appears in the current issue of the journal Cell Metabolism.
Drs. Ming-Jer and Sophia Tsai, professors of molecular and cellular biology at BCM, have studied COUP-TFII (Chicken Ovalbumin Upstream Promoter Transcription Factor II) for decades, but only when they bred mice that had only one gene copy for the factor did they find that the animals had smaller fat cells and increased energy metabolism as well as enhanced response to insulin.
"If a mouse loses one copy of the gene, the animal becomes lean," said Ming-Jer Tsai. "It is more sensitive to the effects of insulin and resistant to obesity from a high fat diet."
Their studies raise the likely possibility that one can use COUP-TFII as a potential drug target for diabetes and obesity treatment.
Identifying a drug that could reduce the effect of COUP-TFII activity has become a future focus for their research, said Sophia Tsai.
"We don't need to inhibit it totally," she said. "Partial inhibition will do the trick as when you lose one copy of the gene, your fat cells are already much smaller and the animal is lean."
The animals not only have less fat, they also have more muscle and burn more energy, said Ming-Jer Tsai.
Drs. Luoping Li and Xin Xie, postdoctoral associates in Dr. Tsai's laboratory were major contributors to the work. Others who took part include Jun Qin, George S. Jeha, Pradip K. Saha, Jun Yan, Claire Menoza Haueter and Lawrence Chan, all of BCM.
Funding for this research came from the National Institutes of Health and the Baylor Diabetes and Endocrinology Research Center funded by the National Institute of Diabetes and Digestive and Kidney Diseases at BCM.
This report will be available at cell/cell-metabolism/home.
For more basic science from Baylor College of Medicine, please go to bcm/fromthelab.
Drs. Ming-Jer and Sophia Tsai, professors of molecular and cellular biology at BCM, have studied COUP-TFII (Chicken Ovalbumin Upstream Promoter Transcription Factor II) for decades, but only when they bred mice that had only one gene copy for the factor did they find that the animals had smaller fat cells and increased energy metabolism as well as enhanced response to insulin.
"If a mouse loses one copy of the gene, the animal becomes lean," said Ming-Jer Tsai. "It is more sensitive to the effects of insulin and resistant to obesity from a high fat diet."
Their studies raise the likely possibility that one can use COUP-TFII as a potential drug target for diabetes and obesity treatment.
Identifying a drug that could reduce the effect of COUP-TFII activity has become a future focus for their research, said Sophia Tsai.
"We don't need to inhibit it totally," she said. "Partial inhibition will do the trick as when you lose one copy of the gene, your fat cells are already much smaller and the animal is lean."
The animals not only have less fat, they also have more muscle and burn more energy, said Ming-Jer Tsai.
Drs. Luoping Li and Xin Xie, postdoctoral associates in Dr. Tsai's laboratory were major contributors to the work. Others who took part include Jun Qin, George S. Jeha, Pradip K. Saha, Jun Yan, Claire Menoza Haueter and Lawrence Chan, all of BCM.
Funding for this research came from the National Institutes of Health and the Baylor Diabetes and Endocrinology Research Center funded by the National Institute of Diabetes and Digestive and Kidney Diseases at BCM.
This report will be available at cell/cell-metabolism/home.
For more basic science from Baylor College of Medicine, please go to bcm/fromthelab.
Campaign Against Chronic Diseases Set For The Caribbean
A major new campaign to fight chronic disease in the Caribbean is getting underway in an effort to stem "the worst epidemic of chronic diseases like heart disease, stroke, cancer, diabetes and chronic respiratory disease in the Americas," with the participation of heads of government.
Government leaders want to work together to reduce risk factors such as obesity, unhealthy food choices, physical inactivity, high cholesterol and tobacco use, which contribute to making chronic diseases the leading causes of death in Caribbean countries, according to the Pan American Health Organization's Dr. James Hospedales.
PAHO and the Caribbean Community organized a historic summit, "Stemming the Tide of Non-communicable Diseases in the Caribbean, hosted by the Prime Minister of Trinidad & Tobago, the Hon. Patrick Manning, to launch the watershed regional campaign against chronic diseases.
Government leaders including the Chairman of CARICOM, Hon. Owen Arthur, Prime Minister of Barbados, Dr. Denzil Douglas, Prime Minister of St Kitts & Nevis, and Secretary General of CARICOM Edwin Carrington, along with the chairman of the Caribbean Commission on Health and Development, Dr. George Alleyne, are calling for regional unity to stop the epidemic of chronic "lifestyle" diseases, which account for more than half the incidence of death and disease in the CARICOM region.
"That we are meeting as Heads of Government on this matter indicates the priority that CARICOM has placed on the topic," Prime Minister Manning said, noting that tobacco taxes were a good initial step but that a comprehensive public education program on lifestyle management, in partnership with the media, is also needed.
Dr. Alleyne also said the Caribbean summit focus on individual responsibility for the reduction of chronic diseases must be coupled with the need for policy makers to create an enabling environment which that empowers individuals to manage their own lifestyle, and with a regional public education program to inform people about the magnitude of chronic diseases and how to help reduce risk factors for them.
Both in the Caribbean and in Latin America, chronic diseases are now the leading cause of premature mortality, accounting for nearly half the deaths of persons under 70, and for two out of three deaths overall. In the current decade, cardiovascular diseases are expected to claim 20.7 million lives in the Americas, and predictions for the next 20 years include a tripling of heart disease and stroke mortality in Latin America.
Dr Edward Greene, Assistant Secretary General of the CARICOM Secretariat, said critical concerns also include measures on food importation, production and pricing to help ensure that people can afford to buy healthy foods. The assault on chronic diseases comes in the wake of the recommendations of the Commission on Health and Development, which reasserted the need for better food choices and greater physical activity on the part of Caribbean populations and advocated public policy measures by Caribbean Governments to modulate the environment.
The Caribbean summit Sept. 15 was organized by CARICOM and PAHO, with heads of government, other decision and policy makers, and regional and international organizations to curtail lifestyle-related diseases such as obesity, high blood pressure, diabetes, stroke, heart attack and cancer.
The Pan American Health Organization, regional office for the Americas of the World Health Organization, works with all the countries of the Americas to improve the health and raise living standards of their peoples.
Pan American Health Organization
View drug information on Carrington patch.
Government leaders want to work together to reduce risk factors such as obesity, unhealthy food choices, physical inactivity, high cholesterol and tobacco use, which contribute to making chronic diseases the leading causes of death in Caribbean countries, according to the Pan American Health Organization's Dr. James Hospedales.
PAHO and the Caribbean Community organized a historic summit, "Stemming the Tide of Non-communicable Diseases in the Caribbean, hosted by the Prime Minister of Trinidad & Tobago, the Hon. Patrick Manning, to launch the watershed regional campaign against chronic diseases.
Government leaders including the Chairman of CARICOM, Hon. Owen Arthur, Prime Minister of Barbados, Dr. Denzil Douglas, Prime Minister of St Kitts & Nevis, and Secretary General of CARICOM Edwin Carrington, along with the chairman of the Caribbean Commission on Health and Development, Dr. George Alleyne, are calling for regional unity to stop the epidemic of chronic "lifestyle" diseases, which account for more than half the incidence of death and disease in the CARICOM region.
"That we are meeting as Heads of Government on this matter indicates the priority that CARICOM has placed on the topic," Prime Minister Manning said, noting that tobacco taxes were a good initial step but that a comprehensive public education program on lifestyle management, in partnership with the media, is also needed.
Dr. Alleyne also said the Caribbean summit focus on individual responsibility for the reduction of chronic diseases must be coupled with the need for policy makers to create an enabling environment which that empowers individuals to manage their own lifestyle, and with a regional public education program to inform people about the magnitude of chronic diseases and how to help reduce risk factors for them.
Both in the Caribbean and in Latin America, chronic diseases are now the leading cause of premature mortality, accounting for nearly half the deaths of persons under 70, and for two out of three deaths overall. In the current decade, cardiovascular diseases are expected to claim 20.7 million lives in the Americas, and predictions for the next 20 years include a tripling of heart disease and stroke mortality in Latin America.
Dr Edward Greene, Assistant Secretary General of the CARICOM Secretariat, said critical concerns also include measures on food importation, production and pricing to help ensure that people can afford to buy healthy foods. The assault on chronic diseases comes in the wake of the recommendations of the Commission on Health and Development, which reasserted the need for better food choices and greater physical activity on the part of Caribbean populations and advocated public policy measures by Caribbean Governments to modulate the environment.
The Caribbean summit Sept. 15 was organized by CARICOM and PAHO, with heads of government, other decision and policy makers, and regional and international organizations to curtail lifestyle-related diseases such as obesity, high blood pressure, diabetes, stroke, heart attack and cancer.
The Pan American Health Organization, regional office for the Americas of the World Health Organization, works with all the countries of the Americas to improve the health and raise living standards of their peoples.
Pan American Health Organization
View drug information on Carrington patch.
Epidemic Of Unneeded Amputations - Physicians Too Quick To Amputate Despite Medical Advances
Non-traumatic amputations - those caused by arterial blockages related to diabetes, smoking, obesity and vascular system complications - are occurring at an alarming rate. Yet physicians may be too quick to amputate as 85 percent of them may be preventable, according to the International Diabetes Foundation.
Amputations are not only disfiguring and life-threatening, but are more dangerous and more expensive than revascularization, which is the reestablishment of blood supply. Diabetics are especially at risk for non-traumatic amputations, accounting for 82,000 non-traumatic lower extremity amputations (LEAs) in the U.S. yearly, according to the American Diabetes Association. The Centers for Disease Control (CDC) reports more than 60 percent of LEAs occur in diabetics.
These statistics are telling, and have one of the country's leading clinical investigators and cardiologists astounded. "It is shocking that in this day and age, there is an epidemic of unnecessary amputations. Amputation is a drastic procedure that takes a great physical and emotional toll on patients and their families. But physicians often jump too quickly to amputation rather than exploring medical advances that can prevent limb loss," said Dr. Craig Walker, of the Cardiovascular Institute of the South, in Houma, La.
Walker is a pioneer in a medical procedure to combat these trends: Cool Laser Revascularization for Peripheral Artery Therapy, or "CLiRpath."
"In the U.S. alone, there are approximately 1.8 million people living with limb loss," Walker said, citing National Limb Loss Amputation Center statistics. "A good portion of these individuals could have salvaged their limbs. This is tragic." Of note:
--The number of diabetes-related LEA hospital discharges increased by 240 percent between 1980 (33,000) to 2002 (82,000), according to the CDC. --The CDC says the five-year survival rate for all lower extremity amputees is less than 50 percent. For diabetic amputees, the rate is less than 40 percent. --In a five-year study in medical journal Diabetes Care, 40 percent of diabetics and 29.8 percent of non-diabetics had a second amputation to the same or opposite limb at an average of 16.2 and 12.3 months, respectively, after the first amputation.
In advanced stages of peripheral vascular disease (PVD), common in diabetics, plaque blocks arteries, resulting in rest pain, development of foot ulcers and onset of limb loss. The CLiRpath procedure, using a "cool" excimer laser and catheter system developed by Spectranetics Corp. (NASDAQ: SPNC), vaporizes arterial blockages, restores blood flow, and this surgery promotes wound healing, often enabling patients to leave the hospital the next day. CLiRpath has been the subject of rigorous clinical trials, with limb salvage observed in 95 percent of patients surviving to six months(1). The procedure is now available in more than 300 hospitals across the U.S.
Amputation decisions greatly impact lives of many people, like Michael Sevante, of Houma, La. In 2002, Sevante had recurring leg cramps and was diagnosed with PVD. He developed a non-healing infection and underwent an amputation below his left knee. As a result, Sevante had to walk his daughter down the aisle on her wedding day with a walker and a prosthetic limb.
Six months after his first amputation, he experienced similar symptoms in his right leg and decided to aggressively pursue amputation alternatives to avoid having to live in a wheelchair. He was referred to Dr. Walker, who was able to save Sevante's leg with CLiRpath. Today, Sevante is virtually pain free.
"After my first amputation, I would have done anything to avoid a second," said Sevante. "Had I not asked for an alternative, I fear I was on track for the loss of another limb. This would have meant the beginning of the end for me."
About Spectranetics Corp.
For more information about CLiRpath, visit clirpath. Spectranetics is a medical device company that develops, manufactures and markets single-use medical devices used in minimally invasive surgical procedures within the cardiovascular system in conjunction with its proprietary excimer laser system. Its CVX-300(R) excimer laser is the only system approved by the FDA for multiple cardiovascular procedures, including coronary atherectomy, and the removal of problematic pacemaker and defibrillator leads. Nearly all of our FDA-approved and investigational applications have received Communautes Europeennes (CE) mark registration for marketing within Europe. In April 2004, the Company obtained 510(k) clearance from the FDA for the laser-based treatment of patients suffering from total occlusions (blockages) in their leg arteries that are not crossable with a guidewire. For more information, visit spectranetics.
(1) Limb salvage for patients surviving to six months (40/42) in LACI CTRO Registry. Limb salvage by intent to treat analysis at six months was 85 percent (40/47 patients).
Ken Hunter
kenpraco
PRACO
praco
Amputations are not only disfiguring and life-threatening, but are more dangerous and more expensive than revascularization, which is the reestablishment of blood supply. Diabetics are especially at risk for non-traumatic amputations, accounting for 82,000 non-traumatic lower extremity amputations (LEAs) in the U.S. yearly, according to the American Diabetes Association. The Centers for Disease Control (CDC) reports more than 60 percent of LEAs occur in diabetics.
These statistics are telling, and have one of the country's leading clinical investigators and cardiologists astounded. "It is shocking that in this day and age, there is an epidemic of unnecessary amputations. Amputation is a drastic procedure that takes a great physical and emotional toll on patients and their families. But physicians often jump too quickly to amputation rather than exploring medical advances that can prevent limb loss," said Dr. Craig Walker, of the Cardiovascular Institute of the South, in Houma, La.
Walker is a pioneer in a medical procedure to combat these trends: Cool Laser Revascularization for Peripheral Artery Therapy, or "CLiRpath."
"In the U.S. alone, there are approximately 1.8 million people living with limb loss," Walker said, citing National Limb Loss Amputation Center statistics. "A good portion of these individuals could have salvaged their limbs. This is tragic." Of note:
--The number of diabetes-related LEA hospital discharges increased by 240 percent between 1980 (33,000) to 2002 (82,000), according to the CDC. --The CDC says the five-year survival rate for all lower extremity amputees is less than 50 percent. For diabetic amputees, the rate is less than 40 percent. --In a five-year study in medical journal Diabetes Care, 40 percent of diabetics and 29.8 percent of non-diabetics had a second amputation to the same or opposite limb at an average of 16.2 and 12.3 months, respectively, after the first amputation.
In advanced stages of peripheral vascular disease (PVD), common in diabetics, plaque blocks arteries, resulting in rest pain, development of foot ulcers and onset of limb loss. The CLiRpath procedure, using a "cool" excimer laser and catheter system developed by Spectranetics Corp. (NASDAQ: SPNC), vaporizes arterial blockages, restores blood flow, and this surgery promotes wound healing, often enabling patients to leave the hospital the next day. CLiRpath has been the subject of rigorous clinical trials, with limb salvage observed in 95 percent of patients surviving to six months(1). The procedure is now available in more than 300 hospitals across the U.S.
Amputation decisions greatly impact lives of many people, like Michael Sevante, of Houma, La. In 2002, Sevante had recurring leg cramps and was diagnosed with PVD. He developed a non-healing infection and underwent an amputation below his left knee. As a result, Sevante had to walk his daughter down the aisle on her wedding day with a walker and a prosthetic limb.
Six months after his first amputation, he experienced similar symptoms in his right leg and decided to aggressively pursue amputation alternatives to avoid having to live in a wheelchair. He was referred to Dr. Walker, who was able to save Sevante's leg with CLiRpath. Today, Sevante is virtually pain free.
"After my first amputation, I would have done anything to avoid a second," said Sevante. "Had I not asked for an alternative, I fear I was on track for the loss of another limb. This would have meant the beginning of the end for me."
About Spectranetics Corp.
For more information about CLiRpath, visit clirpath. Spectranetics is a medical device company that develops, manufactures and markets single-use medical devices used in minimally invasive surgical procedures within the cardiovascular system in conjunction with its proprietary excimer laser system. Its CVX-300(R) excimer laser is the only system approved by the FDA for multiple cardiovascular procedures, including coronary atherectomy, and the removal of problematic pacemaker and defibrillator leads. Nearly all of our FDA-approved and investigational applications have received Communautes Europeennes (CE) mark registration for marketing within Europe. In April 2004, the Company obtained 510(k) clearance from the FDA for the laser-based treatment of patients suffering from total occlusions (blockages) in their leg arteries that are not crossable with a guidewire. For more information, visit spectranetics.
(1) Limb salvage for patients surviving to six months (40/42) in LACI CTRO Registry. Limb salvage by intent to treat analysis at six months was 85 percent (40/47 patients).
Ken Hunter
kenpraco
PRACO
praco
Half Of Americans Have Gene That Affects How Body Burns Sugar
A recent study by a Saint Louis University researcher confirms findings that about half of the U.S. population has a version of a gene that causes them to metabolize food differently, putting them at greater risk of developing diabetes.
Edward Weiss, Ph.D., assistant professor of nutrition and dietetics at Doisy College of Health Sciences at Saint Louis University, looked at a relatively common version of a gene called FABP2, which is involved in the absorption of fat from food.
Those people with the variant gene processed fat differently than those who don't have it. They burned more fat, which may have hindered their ability to remove sugar from the blood stream and burn it. Diabetes is characterized by too much sugar in the blood.
"This study adds to what was previously known about this gene variant by showing that after consuming a very rich milkshake, people with the variant gene process the fat from the drink differently than other people," Weiss says.
That is not to say that half of U.S. residents are destined to get diabetes, he adds.
"While the variation of the gene appears to contribute to the diabetes risk, it does not cause diabetes by itself," Weiss says.
"Many other genes, some known and some unknown, are involved in a person's overall risk of developing diabetes. Those are things a person can't control. But there are risk factors for diabetes that a person can change -- lifestyle factors, such as diet and exercise."
The study was published in the January issue of the American Journal of Clinical Nutrition.
Contact: Nancy Solomon
Saint Louis University
Edward Weiss, Ph.D., assistant professor of nutrition and dietetics at Doisy College of Health Sciences at Saint Louis University, looked at a relatively common version of a gene called FABP2, which is involved in the absorption of fat from food.
Those people with the variant gene processed fat differently than those who don't have it. They burned more fat, which may have hindered their ability to remove sugar from the blood stream and burn it. Diabetes is characterized by too much sugar in the blood.
"This study adds to what was previously known about this gene variant by showing that after consuming a very rich milkshake, people with the variant gene process the fat from the drink differently than other people," Weiss says.
That is not to say that half of U.S. residents are destined to get diabetes, he adds.
"While the variation of the gene appears to contribute to the diabetes risk, it does not cause diabetes by itself," Weiss says.
"Many other genes, some known and some unknown, are involved in a person's overall risk of developing diabetes. Those are things a person can't control. But there are risk factors for diabetes that a person can change -- lifestyle factors, such as diet and exercise."
The study was published in the January issue of the American Journal of Clinical Nutrition.
Contact: Nancy Solomon
Saint Louis University
Brummie Girls With Type 1 Diabetes More At Risk Of Complications, UK
Girls in Birmingham with Type 1 diabetes have poorer blood glucose control than Brummie boys, according to new research presented at Diabetes UK's Annual Professional Conference.
This could be putting them at greater risk of short-term diabetes complications such as diabetic ketoacidosis (DKA), which occurs when blood glucose levels are consistently high.
In the long term, poor diabetes management can lead to complications such as heart disease, stroke, blindness and kidney failure.
Gender difference
The study, based on data submitted to the National Diabetes Audit, looked at 369 children with Type 1 diabetes at the Diabetes Unit at Birmingham Children's Hospital between May 2006 and April 2007.
It revealed that 23.8 per cent of boys up to the age of 18 achieved the recommended blood glucose targets (HbA1c) of less than 7.5 per cent compared to only 11.8 per cent of girls.
The research found the five to 11 age range showed the biggest disparity between boys and girls, with only 6.3 per cent of girls achieving the recommended blood glucose targets compared to 27.6 per cent of boys.
It also found that more girls up to the age of 18 (9.2 per cent) than boys (6.5 per cent) experienced episodes of DKA.
More research would be welcomed
"This study shows a significant and startling difference between boys and girls with Type 1 diabetes achieving their blood glucose level targets in Birmingham," said Peter Shorrick, Regional Manager for Diabetes UK West Midlands.
"We look forward to seeing more research to determine why this difference has occurred and to find ways of helping girls with Type 1 diabetes attain better diabetes control."
Conducting more research to pinpoint causes
Dr Timothy Barrett from Birmingham Children's Unit, who carried out the research, said: "It is interesting that boys of school age are better at controlling their diabetes than girls of the same age, especially as we expected the result to be the other way around. We are not sure exactly why this is the case but we are conducting more research to pinpoint any causes.
Good management linked to weight?
"One possibility is that good diabetes management is linked to weight, and that the more overweight a child, the worse their blood glucose level control. It is thought that obesity affects girls more than boys so this could very well be an important factor, although we did not detect obvious weight differences in this group."
Type 1 diabetes in under-15s in the UK
In the UK there are about 20,000 children with Type 1 diabetes under the age of 15, with roughly an equal split between boys and girls.
Diabetes UK
This could be putting them at greater risk of short-term diabetes complications such as diabetic ketoacidosis (DKA), which occurs when blood glucose levels are consistently high.
In the long term, poor diabetes management can lead to complications such as heart disease, stroke, blindness and kidney failure.
Gender difference
The study, based on data submitted to the National Diabetes Audit, looked at 369 children with Type 1 diabetes at the Diabetes Unit at Birmingham Children's Hospital between May 2006 and April 2007.
It revealed that 23.8 per cent of boys up to the age of 18 achieved the recommended blood glucose targets (HbA1c) of less than 7.5 per cent compared to only 11.8 per cent of girls.
The research found the five to 11 age range showed the biggest disparity between boys and girls, with only 6.3 per cent of girls achieving the recommended blood glucose targets compared to 27.6 per cent of boys.
It also found that more girls up to the age of 18 (9.2 per cent) than boys (6.5 per cent) experienced episodes of DKA.
More research would be welcomed
"This study shows a significant and startling difference between boys and girls with Type 1 diabetes achieving their blood glucose level targets in Birmingham," said Peter Shorrick, Regional Manager for Diabetes UK West Midlands.
"We look forward to seeing more research to determine why this difference has occurred and to find ways of helping girls with Type 1 diabetes attain better diabetes control."
Conducting more research to pinpoint causes
Dr Timothy Barrett from Birmingham Children's Unit, who carried out the research, said: "It is interesting that boys of school age are better at controlling their diabetes than girls of the same age, especially as we expected the result to be the other way around. We are not sure exactly why this is the case but we are conducting more research to pinpoint any causes.
Good management linked to weight?
"One possibility is that good diabetes management is linked to weight, and that the more overweight a child, the worse their blood glucose level control. It is thought that obesity affects girls more than boys so this could very well be an important factor, although we did not detect obvious weight differences in this group."
Type 1 diabetes in under-15s in the UK
In the UK there are about 20,000 children with Type 1 diabetes under the age of 15, with roughly an equal split between boys and girls.
Diabetes UK
GlaxoSmithKline Updates Prescribing Information For Avandia
GlaxoSmithKline (NYSE:
GSK) today announced that the US Food and Drug Administration (FDA) has
approved updated US prescribing information for the thiazolidinediones
(TZD) class of medicines used in the treatment of Type 2 diabetes. This
approval allows GSK to implement changes in the label for Avandia(R)
(rosiglitazone maleate) as previously committed.
The label will contain a boxed warning, which increases the prominence
of an already existing warning for all medicines in the TZD class on the
risk of congestive heart failure (CHF), a well known and well characterized
risk in this class of medicine. The boxed warning also will note that TZDs
are not recommended in patients with symptomatic heart failure, and that
initiation of TZDs in patients with established NYHA Class III or IV heart
failure is contraindicated. The Contraindications have also been updated
regarding initiation of Avandia in patients with NYHA Class III or IV heart
failure.
Information about CHF has been included in the prescribing information
for Avandia since 1999, when the medicine was first approved by the US Food
and Drug Administration. Since 2001, US prescribing information for Avandia
has included a warning for "Cardiac Failure and Other Cardiac Effects" with
a recommendation that use of Avandia be discontinued in patients if their
cardiac status worsened.
The changes related to CHF are being implemented on the labels of all
rosiglitazone-containing products: Avandia, Avandamet(R) (rosiglitazone
maleate and metformin hydrochloride) and Avandaryl(TM) (rosiglitazone
maleate and glimepiride).
More than 4.5 million Americans suffer from CHF, which also is one of
the most common complications of type 2 diabetes. CHF is a condition in
which the heart cannot pump enough blood to the body's other organs, which
can result in fluid retention, or edema. It is also well known that TZDs
can cause some fluid retention, which can lead to or worsen CHF.
The change in CHF labeling is not related to the FDA's review of
additional data on the risk of myocardial ischemic events, which include
heart attack. The FDA held an Advisory Committee meeting on July 30th to
review that data.
Important Safety Information for Avandia(R) (rosiglitazone maleate)
Avandia, along with diet and exercise, helps improve blood sugar
control. It may be taken alone or with other diabetes medicines. For some
people taking Avandia, possible side effects include heart failure or other
heart problems. Further information regarding potential heart-related risks
is currently under review by the FDA. Talk to your doctor as FDA has made
information on potential heart-related risks available to physicians on its
website at fda. Tell your doctor if you have heart problems or heart failure. Avandia can cause your body to keep extra fluid, which
leads to swelling and weight gain. Extra body fluid can make some heart
problems worse or lead to heart failure. If you have swelling or fluid
retention, shortness of breath or trouble breathing, an unusually rapid
increase in weight, or unusual tiredness while taking Avandia, call your
doctor right away. You should not take Avandia if you have liver problems.
Blood tests should be used to check for liver problems before starting and
while taking Avandia. Tell your doctor if you have liver disease, or if you
experience unexplained tiredness, stomach problems, dark urine or yellowing
of skin while taking Avandia. Tell your doctor about all of the medicines
you are taking. If you are taking Avandia with another diabetes medicine
that lowers blood sugar, you may be at increased risk for low blood sugar.
Ask your doctor whether you need to lower the dose of your other diabetes
medicine. Avandia may increase your risk of pregnancy. Talk to your doctor
before taking Avandia if you could become pregnant or if you are pregnant.
If you are nursing, you should not take Avandia. Talk to your doctor for
advice on how to keep your bones healthy. More fractures, usually in the
upper arm, hand, or foot, have been seen in women taking Avandia. Your
doctor should check your eyes regularly. Very rarely, some people have
experienced vision
GlaxoSmithKline -- one of the world's leading research-based
pharmaceutical and healthcare companies -- is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. For company information, visit GlaxoSmithKline on the World Wide
Web at gsk.
GlaxoSmithKline
gsk
View drug information on Avandia.
GSK) today announced that the US Food and Drug Administration (FDA) has
approved updated US prescribing information for the thiazolidinediones
(TZD) class of medicines used in the treatment of Type 2 diabetes. This
approval allows GSK to implement changes in the label for Avandia(R)
(rosiglitazone maleate) as previously committed.
The label will contain a boxed warning, which increases the prominence
of an already existing warning for all medicines in the TZD class on the
risk of congestive heart failure (CHF), a well known and well characterized
risk in this class of medicine. The boxed warning also will note that TZDs
are not recommended in patients with symptomatic heart failure, and that
initiation of TZDs in patients with established NYHA Class III or IV heart
failure is contraindicated. The Contraindications have also been updated
regarding initiation of Avandia in patients with NYHA Class III or IV heart
failure.
Information about CHF has been included in the prescribing information
for Avandia since 1999, when the medicine was first approved by the US Food
and Drug Administration. Since 2001, US prescribing information for Avandia
has included a warning for "Cardiac Failure and Other Cardiac Effects" with
a recommendation that use of Avandia be discontinued in patients if their
cardiac status worsened.
The changes related to CHF are being implemented on the labels of all
rosiglitazone-containing products: Avandia, Avandamet(R) (rosiglitazone
maleate and metformin hydrochloride) and Avandaryl(TM) (rosiglitazone
maleate and glimepiride).
More than 4.5 million Americans suffer from CHF, which also is one of
the most common complications of type 2 diabetes. CHF is a condition in
which the heart cannot pump enough blood to the body's other organs, which
can result in fluid retention, or edema. It is also well known that TZDs
can cause some fluid retention, which can lead to or worsen CHF.
The change in CHF labeling is not related to the FDA's review of
additional data on the risk of myocardial ischemic events, which include
heart attack. The FDA held an Advisory Committee meeting on July 30th to
review that data.
Important Safety Information for Avandia(R) (rosiglitazone maleate)
Avandia, along with diet and exercise, helps improve blood sugar
control. It may be taken alone or with other diabetes medicines. For some
people taking Avandia, possible side effects include heart failure or other
heart problems. Further information regarding potential heart-related risks
is currently under review by the FDA. Talk to your doctor as FDA has made
information on potential heart-related risks available to physicians on its
website at fda. Tell your doctor if you have heart problems or heart failure. Avandia can cause your body to keep extra fluid, which
leads to swelling and weight gain. Extra body fluid can make some heart
problems worse or lead to heart failure. If you have swelling or fluid
retention, shortness of breath or trouble breathing, an unusually rapid
increase in weight, or unusual tiredness while taking Avandia, call your
doctor right away. You should not take Avandia if you have liver problems.
Blood tests should be used to check for liver problems before starting and
while taking Avandia. Tell your doctor if you have liver disease, or if you
experience unexplained tiredness, stomach problems, dark urine or yellowing
of skin while taking Avandia. Tell your doctor about all of the medicines
you are taking. If you are taking Avandia with another diabetes medicine
that lowers blood sugar, you may be at increased risk for low blood sugar.
Ask your doctor whether you need to lower the dose of your other diabetes
medicine. Avandia may increase your risk of pregnancy. Talk to your doctor
before taking Avandia if you could become pregnant or if you are pregnant.
If you are nursing, you should not take Avandia. Talk to your doctor for
advice on how to keep your bones healthy. More fractures, usually in the
upper arm, hand, or foot, have been seen in women taking Avandia. Your
doctor should check your eyes regularly. Very rarely, some people have
experienced vision
GlaxoSmithKline -- one of the world's leading research-based
pharmaceutical and healthcare companies -- is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. For company information, visit GlaxoSmithKline on the World Wide
Web at gsk.
GlaxoSmithKline
gsk
View drug information on Avandia.
Accurately And Efficiently Monitor The Performance Of HbA1c Assays
The American Diabetes Association, International Diabetes Federation and European Association for the Study of Diabetes consider HbA1c a more reliable indicator of long term diabetic control than blood glucose.
In order to have confidence in the patient results reported good quality control is essential. A good control should be consistent over repeated analysis; have a good working stability and a long shelf life Randox can provide just this.
The new HbA1c control from Randox is made from 100% human whole blood and is designed to accurately and efficiently monitor the performance of HbA1c assays.
Accurately assigned % HbA1c target values and ranges with corresponding Total Haemoglobin and HbA1c concentration values are provided for all major systems and methods including HPLC.
Our HbA1c controls are lyophilised providing enhanced shelf life and stability. An extended shelf life reduces the frequency of lot crossovers and allows you to sequester and use the same lot of control over a number of years significantly reducing reagent costs. A working stability of 28 days at 2-8oC minimises waste and saves money.
To complement our HbA1c controls an HbA1c linearity set is also available designed to verify the linearity of HbA1c assays across the clinically important range. Four clinically significant levels are provided eliminating the requirement for very low and or very high patient samples normally used to assess linearity. Like our HbA1c controls the linearity set is suitable for use on all platforms and contains accurately assigned values for the most common analysers and methods. In addition to this we also have an EQA programme available on RIQAS the world's largest global EQA scheme.
In order to have confidence in the patient results reported good quality control is essential. A good control should be consistent over repeated analysis; have a good working stability and a long shelf life Randox can provide just this.
The new HbA1c control from Randox is made from 100% human whole blood and is designed to accurately and efficiently monitor the performance of HbA1c assays.
Accurately assigned % HbA1c target values and ranges with corresponding Total Haemoglobin and HbA1c concentration values are provided for all major systems and methods including HPLC.
Our HbA1c controls are lyophilised providing enhanced shelf life and stability. An extended shelf life reduces the frequency of lot crossovers and allows you to sequester and use the same lot of control over a number of years significantly reducing reagent costs. A working stability of 28 days at 2-8oC minimises waste and saves money.
To complement our HbA1c controls an HbA1c linearity set is also available designed to verify the linearity of HbA1c assays across the clinically important range. Four clinically significant levels are provided eliminating the requirement for very low and or very high patient samples normally used to assess linearity. Like our HbA1c controls the linearity set is suitable for use on all platforms and contains accurately assigned values for the most common analysers and methods. In addition to this we also have an EQA programme available on RIQAS the world's largest global EQA scheme.
Diabetes Patients Who Undergo Bariatric Surgery Require Fewer Medications
Type 2 diabetes patients who underwent bariatric surgery appear to require significantly less medication and incur considerably lower health costs, says a report published in this month's issue of Archives of Surgery, a JAMA/Archives journal. Bariatric surgery is a surgical procedure on the stomach and/or intestines to help extremely obese people lose weight - it is an option for patients with a BMI ( body mass index) above 40.
,br>
The authors write, as background information in their report:
The rapidly growing epidemics of obesity and diabetes threaten to overburden the world's health care systems. From an epidemiological standpoint, once these diseases develop they are rarely reversed. Dietary, pharmaceutical and behavior treatments for obesity are associated with high failure rates, and medical management of diabetes is also often unsuccessful. Despite many efforts to improve the control of glucose levels in diabetes, including clinical guidelines and patient and provider education, less than half of all patients with type 2 diabetes mellitus achieve the American Diabetes Association recommendation of a hemoglobin A1C level of less than 7 percent."
The authors note that bariatric surgery use, that results in long-term weight loss, significantly better lifestyle and lower death risk, has tripled during the last five years.
Martin A. Makary, M.D., M.P.H., and team at the Johns Hopkins Bloomberg School of Public Health and The Johns Hopkins University School of Medicine, Baltimore, examined data on 2,235 U.S. adults (average age 48.4) with type 2 diabetes who had undergone bariatric surgery between the years 2002 and the end of 2005 (four year period). Claims data was used to measure pre- and post-surgery diabetes medication use, as well as health care costs per year.
The study revealed that of the 2,235 patients:
85.8% (1,918) were taking at least one diabetes drug before surgery (average 4.4 medications per patient).
6 months after surgery, 74.7% (1,669) of patients had stopped taking their diabetes medications altogether.
Of the 1,847 patients with available data one year after surgery, 80.6% (1,489) had eliminated medications; after two years, 906 of 1,072 (84.5 percent) had done so. This reduction was detected in all classes of diabetes medications.
The researchers wrote:
We observed that independence from diabetes medication was almost immediate within the initial months after surgery and did not correlate with the gradual weight loss expected. This supports the theory that the resolution of diabetes is not due to weight loss alone but is also mediated by gastric hormones, with the three most implicated being peptide YY, glucagonlike peptide and pancreatic polypeptide. As a known mediator of insulin regulation, glucagonlike peptide levels have been noted to increase immediately after bariatric surgery and may explain why surgeons have noted complete resolution of diabetes in some cases within days after surgery.
Health care costs:
In the two years before surgery health care costs averaged $6,376 annually
The median/midpoint cost of surgery and hospitalization was $29,959
Total yearly health care costs rose by $616 (9.7%) in the year after the bariatric surgery
Total yearly health care costs dropped by $2,179 (34.2%) in year two after surgery
Total yearly health care costs dropped by $4,498 (70.5%) in year three after surgery
The scientists concluded:
Based on these data, we have identified several important implications for health care delivery and public policy. Foremost, eligible obese patients should be properly informed of the risks and benefits of bariatric surgery compared with non-surgical health management. Health care providers should consider discussing bariatric surgery in the treatment of obese patients with type 2 diabetes. Health insurers, private and public, should pay for bariatric surgery for appropriate candidates, recognizing a potential annualized cost savings in addition to the benefit to health.
Arch Surg
Published August. 2010;145[8]:726-731.
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The authors write, as background information in their report:
The rapidly growing epidemics of obesity and diabetes threaten to overburden the world's health care systems. From an epidemiological standpoint, once these diseases develop they are rarely reversed. Dietary, pharmaceutical and behavior treatments for obesity are associated with high failure rates, and medical management of diabetes is also often unsuccessful. Despite many efforts to improve the control of glucose levels in diabetes, including clinical guidelines and patient and provider education, less than half of all patients with type 2 diabetes mellitus achieve the American Diabetes Association recommendation of a hemoglobin A1C level of less than 7 percent."
The authors note that bariatric surgery use, that results in long-term weight loss, significantly better lifestyle and lower death risk, has tripled during the last five years.
Martin A. Makary, M.D., M.P.H., and team at the Johns Hopkins Bloomberg School of Public Health and The Johns Hopkins University School of Medicine, Baltimore, examined data on 2,235 U.S. adults (average age 48.4) with type 2 diabetes who had undergone bariatric surgery between the years 2002 and the end of 2005 (four year period). Claims data was used to measure pre- and post-surgery diabetes medication use, as well as health care costs per year.
The study revealed that of the 2,235 patients:
85.8% (1,918) were taking at least one diabetes drug before surgery (average 4.4 medications per patient).
6 months after surgery, 74.7% (1,669) of patients had stopped taking their diabetes medications altogether.
Of the 1,847 patients with available data one year after surgery, 80.6% (1,489) had eliminated medications; after two years, 906 of 1,072 (84.5 percent) had done so. This reduction was detected in all classes of diabetes medications.
The researchers wrote:
We observed that independence from diabetes medication was almost immediate within the initial months after surgery and did not correlate with the gradual weight loss expected. This supports the theory that the resolution of diabetes is not due to weight loss alone but is also mediated by gastric hormones, with the three most implicated being peptide YY, glucagonlike peptide and pancreatic polypeptide. As a known mediator of insulin regulation, glucagonlike peptide levels have been noted to increase immediately after bariatric surgery and may explain why surgeons have noted complete resolution of diabetes in some cases within days after surgery.
Health care costs:
In the two years before surgery health care costs averaged $6,376 annually
The median/midpoint cost of surgery and hospitalization was $29,959
Total yearly health care costs rose by $616 (9.7%) in the year after the bariatric surgery
Total yearly health care costs dropped by $2,179 (34.2%) in year two after surgery
Total yearly health care costs dropped by $4,498 (70.5%) in year three after surgery
The scientists concluded:
Based on these data, we have identified several important implications for health care delivery and public policy. Foremost, eligible obese patients should be properly informed of the risks and benefits of bariatric surgery compared with non-surgical health management. Health care providers should consider discussing bariatric surgery in the treatment of obese patients with type 2 diabetes. Health insurers, private and public, should pay for bariatric surgery for appropriate candidates, recognizing a potential annualized cost savings in addition to the benefit to health.
Arch Surg
Published August. 2010;145[8]:726-731.
US Diabetic Retinopathy Increase: Statement From American Academy Of Ophthalmology
The American Academy of Ophthalmology (Academy) considers this study reliable evidence that diabetic retinopathy and vision-threatening diabetic retinopathy are increasing in adults over age 40 in the United States and that more Americans, especially non-Hispanic black Americans, will be vulnerable to potentially-blinding diabetic retinopathy in coming years. The Academy reminds those who have diabetes or are at risk for the disease-especially people with black, Latino, Native American or Pacific Islander heritage-that having an annual dilated eye exam by an Eye M.D. (ophthalmologist) is an important step toward protecting their eyes and vision, along with proper medical care, careful glycemic (blood sugar) control, and other lifestyle choices that reduce the health impacts of diabetes.
As this study concludes, the US will likely face a growing need for diabetes-related eye care, and particularly for new care models that address limited access and other disparities linked to higher diabetic retinopathy in minority populations. The Academy's EyeSmart EyeCheck campaign addresses this need by providing free screenings to communities considered at high risk for eye diseases such as diabetic retinopathy. Through the EyeCare America program, the Academy works toward insuring that Americans age 65 and older receive appropriate care, often at no cost, for vision-threatening illnesses.
The study, published August 11, 2010 in the Journal of the American Medical Association (JAMA), was supported by the National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC); funding for the NHANES retinal component was provided by Division of Diabetes Translation, CDC, and the vision component was funded by the National Eye Institute, National Institute of Health.
As this study concludes, the US will likely face a growing need for diabetes-related eye care, and particularly for new care models that address limited access and other disparities linked to higher diabetic retinopathy in minority populations. The Academy's EyeSmart EyeCheck campaign addresses this need by providing free screenings to communities considered at high risk for eye diseases such as diabetic retinopathy. Through the EyeCare America program, the Academy works toward insuring that Americans age 65 and older receive appropriate care, often at no cost, for vision-threatening illnesses.
The study, published August 11, 2010 in the Journal of the American Medical Association (JAMA), was supported by the National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC); funding for the NHANES retinal component was provided by Division of Diabetes Translation, CDC, and the vision component was funded by the National Eye Institute, National Institute of Health.
Studies Investigate Childhood Obesity, Diabetes And Related Conditions - Archives Of Pediatrics & Adolescent Medicine
Factors identified early in childhood could predict obesity in the teen years and beyond, and researchers continue to assess methods to prevent and treat excess weight gain and its consequences in children and teens, according to several reports published in the April issue of Archives of Pediatrics & Adolescent Medicine, one of the JAMA/Archives journals.
The issue-a theme issue on childhood obesity and diabetes-is being published in conjunction with a JAMA theme issue on diabetes. The March issue of Archives of Ophthalmology and Archives of Neurology, along with the April issues of Archives of Dermatology and Archives of Surgery, also feature research on diabetes, obesity and their related co-morbidities.
Studies featured in this issue include the following:
School-Based Intervention Changes Some, But Not All, Behaviors and Measures of Obesity
An interdisciplinary program designed to increase awareness of obesity and change the behaviors of Dutch school children appears to have reduced the amount of sugary beverages consumed by boys and girls and also improved body composition in girls alone, but did not seem to affect other behaviors. Amika S. Singh, Ph.D., and colleagues at VU University Medical Center, EMGO Institute, Amsterdam, the Netherlands, assessed the effectiveness of the intervention among 1,108 adolescents (average age 12.7). The program included 11 lessons in biology, physical education and lifestyle changes over eight months.
Students at the 10 schools that participated in the program drank fewer sugar-sweetened beverages at the end of the intervention (287 milliliters per day less for boys and 249 milliliters per day less for girls) and 12 months later (233 milliliters per day less for boys and 271 milliliters per day less for girls) than did those in the eight schools that did not participate. In addition, at a 20-month follow-up, the intervention remained effective in preventing unfavorable increases in the sum of all skinfold measurements (taken at the triceps, biceps, below the shoulder and between the hip joint and ribcage) in girls. However, no changes were seen in consumption of snacks or in walking or biking to school.
"Hence, our results do not show consistently positive findings on all anthropometric and behavioral outcome measures. Our findings are important, especially when considering the need for evidence on the long-term effectiveness of interventions in the field of obesity prevention," the authors write. "Reducing intake of sugar-containing beverages should therefore be considered a good behavioral target for future interventions aimed at the prevention of overweight among adolescents."
Schools remain "an obvious and important channel for providing obesity-prevention programs, as the vast majority of youth spend a great deal of time each week throughout their development from childhood to young adulthood in schools," writes Leslie A. Lytle, Ph.D., of the University of Minnesota, Minneapolis, in an accompanying editorial. "However, as the extent of the published research in this field is substantial and the findings consistently mixed and modest, it may be time to re-evaluate where the research needs to move."
Arch Pediatr Adolesc Med. 2009;163[4]:309-317, 388-389.
The issue-a theme issue on childhood obesity and diabetes-is being published in conjunction with a JAMA theme issue on diabetes. The March issue of Archives of Ophthalmology and Archives of Neurology, along with the April issues of Archives of Dermatology and Archives of Surgery, also feature research on diabetes, obesity and their related co-morbidities.
Studies featured in this issue include the following:
School-Based Intervention Changes Some, But Not All, Behaviors and Measures of Obesity
An interdisciplinary program designed to increase awareness of obesity and change the behaviors of Dutch school children appears to have reduced the amount of sugary beverages consumed by boys and girls and also improved body composition in girls alone, but did not seem to affect other behaviors. Amika S. Singh, Ph.D., and colleagues at VU University Medical Center, EMGO Institute, Amsterdam, the Netherlands, assessed the effectiveness of the intervention among 1,108 adolescents (average age 12.7). The program included 11 lessons in biology, physical education and lifestyle changes over eight months.
Students at the 10 schools that participated in the program drank fewer sugar-sweetened beverages at the end of the intervention (287 milliliters per day less for boys and 249 milliliters per day less for girls) and 12 months later (233 milliliters per day less for boys and 271 milliliters per day less for girls) than did those in the eight schools that did not participate. In addition, at a 20-month follow-up, the intervention remained effective in preventing unfavorable increases in the sum of all skinfold measurements (taken at the triceps, biceps, below the shoulder and between the hip joint and ribcage) in girls. However, no changes were seen in consumption of snacks or in walking or biking to school.
"Hence, our results do not show consistently positive findings on all anthropometric and behavioral outcome measures. Our findings are important, especially when considering the need for evidence on the long-term effectiveness of interventions in the field of obesity prevention," the authors write. "Reducing intake of sugar-containing beverages should therefore be considered a good behavioral target for future interventions aimed at the prevention of overweight among adolescents."
Schools remain "an obvious and important channel for providing obesity-prevention programs, as the vast majority of youth spend a great deal of time each week throughout their development from childhood to young adulthood in schools," writes Leslie A. Lytle, Ph.D., of the University of Minnesota, Minneapolis, in an accompanying editorial. "However, as the extent of the published research in this field is substantial and the findings consistently mixed and modest, it may be time to re-evaluate where the research needs to move."
Arch Pediatr Adolesc Med. 2009;163[4]:309-317, 388-389.
NPA Responds To Scottish Government Consultation On Diabetes Care
The NPA has responded to the Scottish Government's Better Diabetes Care by calling for the inclusion of community pharmacists in the Diabetes Managed Clinical Network as well as adding diabetes to the Chronic Medication Service.
Margaret Peycke, NPA NHS Information Manager said: "Pharmacists can offer advice and support to those who need more information to be able to take their medication in concordance with the prescribers. We are calling for the inclusion of community pharmacists in the Diabetes Managed Clinical Network - care pathways and IT networks - and diabetes in the Chronic Medication Service which allows patients with a long-term condition to register with a community pharmacy of their choice."
"Pharmacists can encourage patients to attend regular checkups such as at diabetic foot clinics and retinopathy screening. Community pharmacies can help bridge the gap in diabetes service provision."
Source
National Pharmacy Association
Margaret Peycke, NPA NHS Information Manager said: "Pharmacists can offer advice and support to those who need more information to be able to take their medication in concordance with the prescribers. We are calling for the inclusion of community pharmacists in the Diabetes Managed Clinical Network - care pathways and IT networks - and diabetes in the Chronic Medication Service which allows patients with a long-term condition to register with a community pharmacy of their choice."
"Pharmacists can encourage patients to attend regular checkups such as at diabetic foot clinics and retinopathy screening. Community pharmacies can help bridge the gap in diabetes service provision."
Source
National Pharmacy Association
Medications For Blood-Sugar Lowering May Increase Risk For False Positive Results In Cancer Screenings
A study presented at SNM's 57th Annual Meeting suggests that medication ingested to control blood-sugar levels can skew the results of cancer screenings using positron emission tomography (PET), a molecular imaging technique, by increasing absorption in the gut of the PET imaging agent called fluorodeoxyglucose (18F-FDG), which mimics sugar inside the body.
"The use of certain medications can influence where and how much of the imaging agent is taken up by the body," said Kyle Hurtgen, certified nuclear medicine technologist, Saint Louis University Hospital, St. Louis, Mo., and lead author of the study. "It is important for technologists to know the patient's history and use that information to their advantage to help physicians detect cancer and provide the best possible treatment for diabetic patients."
According to the study, diabetic patients taking tablet-form medications to help control blood-sugar levels prior to being screened for cancer using PET showed abnormally high intestinal absorption of 18F-FDG, a sign that normally indicates a cancerous tumor.
Suspiciously high absorption of this agent, which is bound with a molecular compound that acts like glucose and is metabolized by cells in the body as fuel, is seen as a "hot spot" on a PET scan. These hot spots can signal the high metabolic activity of cancer cells, but blood-sugar lowering medications called oral hypoglycemics can cause a similar visual effect that may make diagnosis more difficult. Determining the use of these medications and potentially discontinuing their use prior to imaging may improve diagnostic accuracy for diabetics, especially those suspected of having colon or other bowel cancers.
The study was conducted at Saint Louis University Hospital using advanced PET/CT technology. The research involved the imaging of three groups of patients with known or suspected extraabdominal cancer. Patients in one group had been diagnosed with diabetes mellitus and had taken oral hypoglycemics prior to imaging. Another group included diabetic patients who had not taken these medications and the third group included non-diabetic patients. More than 60 percent of those who had taken oral hypoglycemics were determined to have much higher bowel and intestinal uptake of the tracer than patients in the other two groups, prompting technologists and clinicians to carefully evaluate the use of blood-sugar lowering medications when imaging diabetic patients.
Scientific Paper 2015: K.W. Hurtgen, N. Nguyen, D. Oliver, M.M. Osman, Nuclear Medicine, Saint Louis University Hospital, St. Louis, Mo., "Impact of Oral Hypoglycemics on 18F-FDG bowel uptake: A technologist perspective," SNM's 57th Annual Meeting, June 5, 2010, Salt Lake City, Utah.
"The use of certain medications can influence where and how much of the imaging agent is taken up by the body," said Kyle Hurtgen, certified nuclear medicine technologist, Saint Louis University Hospital, St. Louis, Mo., and lead author of the study. "It is important for technologists to know the patient's history and use that information to their advantage to help physicians detect cancer and provide the best possible treatment for diabetic patients."
According to the study, diabetic patients taking tablet-form medications to help control blood-sugar levels prior to being screened for cancer using PET showed abnormally high intestinal absorption of 18F-FDG, a sign that normally indicates a cancerous tumor.
Suspiciously high absorption of this agent, which is bound with a molecular compound that acts like glucose and is metabolized by cells in the body as fuel, is seen as a "hot spot" on a PET scan. These hot spots can signal the high metabolic activity of cancer cells, but blood-sugar lowering medications called oral hypoglycemics can cause a similar visual effect that may make diagnosis more difficult. Determining the use of these medications and potentially discontinuing their use prior to imaging may improve diagnostic accuracy for diabetics, especially those suspected of having colon or other bowel cancers.
The study was conducted at Saint Louis University Hospital using advanced PET/CT technology. The research involved the imaging of three groups of patients with known or suspected extraabdominal cancer. Patients in one group had been diagnosed with diabetes mellitus and had taken oral hypoglycemics prior to imaging. Another group included diabetic patients who had not taken these medications and the third group included non-diabetic patients. More than 60 percent of those who had taken oral hypoglycemics were determined to have much higher bowel and intestinal uptake of the tracer than patients in the other two groups, prompting technologists and clinicians to carefully evaluate the use of blood-sugar lowering medications when imaging diabetic patients.
Scientific Paper 2015: K.W. Hurtgen, N. Nguyen, D. Oliver, M.M. Osman, Nuclear Medicine, Saint Louis University Hospital, St. Louis, Mo., "Impact of Oral Hypoglycemics on 18F-FDG bowel uptake: A technologist perspective," SNM's 57th Annual Meeting, June 5, 2010, Salt Lake City, Utah.
Water Intake Could Gauge Diabetes
Rough and tumble summer games send hot and sweaty children running in and out of the house for drinks of water or bathroom trips. While drinking plenty of water, especially when they've been out in the sun, is good for kids, too much can be a bad sign.
A significant increase in thirst and urination are symptoms of diabetes - a disease that is on the rise with children, says Marilyn Alford, senior advanced practice nurse at UT Southwestern Medical Center.
Parents should ask children how many drinks of water they're getting outside and inside and inquire about the number of nighttime bathroom trips. Be alert if little ones start wetting the bed. Consider having your child tested for diabetes if these things seem excessive.
UT Southwestern Medical Center
5323 Harry Hines Blvd.
Dallas, TX 75390-9060
United States
utsouthwestern
A significant increase in thirst and urination are symptoms of diabetes - a disease that is on the rise with children, says Marilyn Alford, senior advanced practice nurse at UT Southwestern Medical Center.
Parents should ask children how many drinks of water they're getting outside and inside and inquire about the number of nighttime bathroom trips. Be alert if little ones start wetting the bed. Consider having your child tested for diabetes if these things seem excessive.
UT Southwestern Medical Center
5323 Harry Hines Blvd.
Dallas, TX 75390-9060
United States
utsouthwestern
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