Posts filed under 'Insulin'
Two National Diabetes-Related Initiatives Coordinated By MCG Bioinformatics Expert
A national effort to develop animal models to study the devastating complications of diabetes is being coordinated by a Medical College of Georgia bioinformatics expert.
Dr. Richard A. McIndoe, associate director of the MCG Center for Biotechnology and Genomic Medicine, has received a $15 million, five-year grant – the largest ever received by MCG – to continue operating the Coordinating and Bioinformatics Unit for the innovative National Institutes of Health project, Animal Models of Diabetic Complications Consortium.
He also will begin providing the same services for the Mouse Metabolic Phenotyping Centers, another NIH-funded consortium of centers offering expertise in sophisticated, expensive mouse testing to scientists nationwide for a variety of diseases including diabetes and its complications as well as obesity and related disorders.
The Animal Models of Diabetic Complications Consortium consists of 13 investigators from different institutions generating ideas for creating mouse models, a Mouse Generation and Husbandry Core to generate the mice and the Coordinating and Bioinformatics Unit to oversee consortium activities.
“The NIH recognized years ago that there were few good animal models that mimic the complications of diabetes,” Dr. McIndoe says. Even the NOD mouse, a spontaneous model for type 1 diabetes, is inadequate, primarily because complications tend to come with age and mice have a relatively short lifespan, he says.
Complications include cardiovascular and kidney disease, diabetic retinopathy as well as damage to the nerves and bladder. “Diabetic cardiovascular disease is probably the biggest mortality risk for type 1 and 2 diabetes; somewhere around 60 to 70 percent of diabetic mortality can be associated with cardiovascular disease,” Dr. McIndoe says.
Unfortunately, the high risk of model development impeded financial support until several years ago when NIH opted to commit funds to make it happen, he says. Scientists who receive funding agree to make their development data and resulting animal models available to the scientific community.
In 2001, while on the University of Florida faculty, Dr. McIndoe received the first grant to provide administrative and coordinating activities for investigators working on model development. Work includes organizing semi-annual Executive Steering Committee meetings, monthly teleconferences, workshops and training sessions and organizing activities for the External Advisory Boards.
A major task was developing a computer system that could take the huge amount of data generated by investigators, store it, analyze it in a flexible way and enable scientists all over the world to access it through a Web portal, www.amdcc.org.
“We have to have a way of storing and capturing all that information in an efficient way so another researcher can go back and do the same experiment or analyze it in real time,” Dr. McIndoe says. “You also need to store information in a way that is very flexible so they can grab the information any way they want. We are constantly adding statistical analysis so data can be analyzed quicker.”
To date, about 70 animal models have been studied, information on about 25 has been deposited in the database Dr. McIndoe developed and about 20 of those models will soon be available for ordering from mouse repositories. Interestingly, there is not necessarily a definitive model for even a single complication, rather an array of models will be necessary as researchers manipulate genes to try and mimic human disease. “They don’t want an animal model that looks like a mouse problem; they want an animal model that looks like a human problem,” he says.
As NIH looked at a second round of funding for the consortium, it took a fresh approach with each investigator proposing two new models and turning them over to a husbandry core for development. “Once created, the models will be sent back to the investigators who will be in charge of understanding the pathology of the complications,” says Dr. McIndoe, noting the operational changes reflect the complexity and magnitude of the work.
NIH also opted to integrate operation of the consortium with the Mouse Metabolic Phenotyping Centers, which also were up for grant renewal. The centers’ first round of funding didn’t include money for administration and bioinformatics, but it was quickly determined both were needed.
“The centers bring to the general scientific community a low-cost way of doing a variety of metabolic assays on mice that would be cost-prohibitive to set up in your local lab,” he says. “For example, if you don’t have a small-animal MRI unit on your campus, there is no way you can do some of these assays.” For a small fee, centers will characterize mouse metabolism, blood components including hormones, energy balance, eating and exercise, organ function and form, physiology and histology. For more information about services and fees, visit www.mmpc.org.
The University of Cincinnati, Vanderbilt University and the University of Washington have been designated as Mouse Metabolic Phenotyping Centers. Additional centers are being solicited through the Coordinating and Bioinformatics Unit at MCG and will be funded through a subcontract with MCG, Dr. McIndoe says.
The Animal Models of Diabetic Complications Consortium and the Mouse Metabolic Phenotyping Centers will continue to function autonomously. But Dr. McIndoe has gutted the infrastructure he created for the AMDCC to accommodate the workings of both. “The face of it will be individual, but the underlying software architecturally works together.”
“This grant, the largest award ever received by MCG, is on target with the NIH’s initiatives to accelerate translation of scientific discoveries into improved health care,” says Dr. Frank Treiber, MCG vice president for research. “Dr. McIndoe’s work will speed the process of understanding the complex interplay between genetic and environmental factors in the development of human diseases such as diabetes and cardiovascular diseases by enabling investigators across the nation to collaborate more efficiently. The scientific community and ultimately all of us benefit from these collaborations that enable access to such rich data bases and promote quicker scientific breakthroughs resulting in improved public health.”
“The MCG School of Medicine is pleased with this major NIH award to Rick McIndoe, which will greatly strengthen our external competitiveness for other center grants,” says Dr. D. Douglas Miller, dean of the School of Medicine. “It also will help our internal planning efforts in the area of data coordination for clinical translational research, a major strategic focus of the school.”
At MCG, Dr. McIndoe also is the local director of informatics for two major newborn screening studies for type 1 diabetes. The studies are following thousands of patients over many years, collecting detailed data on everything from their infections to what that they eat to their fingernail clippings. He also is co-principal investigator on studies looking for biomarkers for type 1 diabetes.
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Contact: Toni Baker
Medical College of Georgia
Add comment March 7, 2007
Are You At Risk For Diabetes? Gold’s Gym Launches National Effort To Fight Diabetes With Fitness
With 65 percent of Americans considered overweight or obese and the epidemic of diabetes continuing to plague our society, Gold’s Gym International, a National Strategic Partner of the American Diabetes Association (ADA), has made a corporate commitment to fight diabetes with fitness.
Starting November 1st, in conjunction with the launch of ADA’s new “I Decide to Fight Diabetes” campaign and American Diabetes Month, Gold’s Gym is unveiling a special online diabetes fitness center that provides free fitness information to anyone affected by the disease. Located at http://www.goldsgym.com/diabetes, its goal is to show Americans how to start an exercise program and incorporate fitness into their lifestyle.
“Diabetes is one of the biggest health crisis’ facing our country today and we are taking action to turn this epidemic around,” said Gene LaMott, president and CEO of Gold’s Gym International. “Even a moderate amount of exercise can control diabetes or prevent type 2 diabetes all together. We’re offering our resources and more than 40 years of expertise to help people develop a simple, easy to follow plan that can save their life.”
At the heart of the new online fitness resource center is a special “Get Started” guide developed by Gold’s Gym that shows consumers how to start an exercise program and stick to it. Whether you’re new to exercise or need a little encouragement to restart a fitness regimen, the guide gives consumers the power to take control of the disease. From goal setting to recommendations on strength training and cardiovascular exercise, the guide offers something for anyone affected by diabetes.
Consumers visiting goldsgym.com/diabetes will also find a link to ADA’s online risk assessment, free passes to their local Gold’s Gym, success stories and a wealth of fitness, motivation and health tips written by the world famous Gold’s Gym Fitness Institute.
“We know from research that 30 minutes of physical activity a day, at least five days a week, can help in delaying or preventing the onset of type 2 diabetes,” said Lynn Nicholas, FACHE, CEO of the American Diabetes Association. “We also know that many people want to start a program for increasing their level of physical activity, but simply don’t know where to begin. This can help provide people with a road map to learn about ways they can increase physical activity every day — whether they are at home, on the road or in a gym.”
In addition to the online resource center, Gold’s Gyms across the country will be opening their doors throughout the month of November to anyone affected by diabetes to offer free fitness education. This includes open houses, free tours of the facilities, free fitness assessments and/or free passes to work out. Consumers are encouraged to visit goldsgym.com or call their local Gold’s Gym to learn what activities they have planned for American Diabetes Month.
The November campaign represents another collaboration between Gold’s Gym and the American Diabetes Association. In 2006, Gold’s Gym became a National Strategic Partner of the Association and sponsors ADA’s signature cycling event, Tour de Cure. This year, Gold’s Gym finished the year as the nation’s top fundraising team by raising over $600,000 in support of the Association’s mission.
More than 75 million Americans are affected by diabetes. It is estimated that nearly 21 million have the disease and another 54 million have pre-diabetes. Even more alarming, recent statistics show that one in three children born today will develop diabetes in their lifetime.
About Gold’s Gym
Established in Venice, Calif. in 1965, Gold’s Gym is the largest co-ed gym chain in the world with more than 600 locations in 43 states and 25 countries. For more information about Gold’s Gym, please visit http://www.goldsgym.com.
About the ADA
For more information on American Diabetes Month please call the American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or visit http://www.diabetes.org.
Gold’s Gym
http://www.goldsgym.com
Add comment March 7, 2007
Drug Could Provide New Treatment Approach For Overweight People With Diabetes
The drug rimonabant, can reduce bodyweight and improve control of blood glucose levels and other cardiovascular risk factors in people with type 2 diabetes, according to an Article in this week’s issue of The Lancet. The findings suggest that this drug could be used as a new approach for treatment of diabetes where other drugs have failed.
Type 2 diabetes is usually diagnosed in adulthood and is treated with either dietary changes alone or drugs. Diabetes is associated with an increased risk of cardiovascular disease, and often coexists with other risk factors, such as abdominal obesity, unhealthy blood lipid levels, and raised blood pressure. The treatment of these risk factors is central to the management of type 2 diabetes.
In the latest study, Andre Scheen (University of Liege, Belgium) and colleagues investigated the effects of rimonabant on 1047 overweight or obese patients with poorly controlled type 2 diabetes, despite treatment with standard diabetes drugs. The patients were given a diet plan that provided slightly fewer calories than they needed and were advised to be more physically active, to help induce weight loss. They were also given either rimonabant–in a dose of either 5 mg per day or 20 mg per day–or a placebo. The patients followed this regimen for a year.
The investigators showed that after a year, patients given rimonabant lost significantly more weight than those given the placebo. Patients given the placebo lost an average of 1-4 kg compared with a weight loss of 2-3 kg in those given 5 mg per day of rimonabant and 5-3 kg in those given a 20 mg per day dose of the drug. Patients given rimonabant also had greater improvements in waist circumference, blood glucose control, blood lipids, and better appetite control than those given the placebo.
The authors conclude: “These findings support the use of 20 mg per day of rimonabant, in addition to diet and exercise, as a new approach to reduce bodyweight and improve blood glucose control as well as several other cardiovascular risk factors in overweight or obese patients with type 2 diabetes that was inadequately controlled by standard treatment.”
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See accompanying Comment.
Professor Andre J Scheen, Department of Medicine, Service de Diabetologie (B35), Nutrition et Maladies Metaboliques, Centre Hospitalier de Liege, CHU Sart Tilman, B-4000 Liege, Belgium.
Contact: Professor Andre J. Scheen
Lancet
Add comment March 7, 2007
Bob Harper Of NBC’s ‘The Biggest Loser’ And Local Diabetes Expert Visit Los Angeles To Help Residents ‘Step Up’ Their Diabetes Management
As part of the major nationwide educational campaign Diabetes & You: Step It Up to Get It Down, life and fitness coach Bob Harper will visit Los Angeles to encourage local residents with type 2 diabetes to better manage their disease. Harper and a panel of diabetes experts convened by the American Association of Clinical Endocrinologists (AACE) developed the easy-to-understand and motivational 6.5 Steps Toward Better Blood Sugar Control. The 6.5 Steps underscore the importance of reaching the AACE target A1C goal of 6.5% or less for most patients through the cornerstones of effective diabetes management — eating healthy, being physically active, monitoring blood sugar, seeing a doctor or other healthcare professional, and, when appropriate, taking one or more medicines. To encourage area residents to “Step It Up,” Mayor Antonio Villaraigosa has declared the week of October 30, 2006 “Diabetes Control Week” in Los Angeles, dedicated to improving blood sugar control for people with type 2 diabetes.
“Type 2 diabetes affects millions of Americans and is an epidemic,” said Bob Harper. “Through my years of coaching and training, I’ve worked with many people with type 2 diabetes and seen how hard it can be to live with this condition. But I learned that anyone can change their life. It’s all about finding the right tools and motivation. I’m challenging people with type 2 diabetes to step it up and use the 6.5 Steps Toward Better Blood Sugar Control. It’s your body — take charge today!”
The Diabetes & You: Step It Up to Get It Down campaign was developed in response to a first-of-its-kind report issued last year by AACE showing that two out of three Americans with type 2 diabetes analyzed in a study were not in control of their blood sugar — failing to meet the AACE-recommended A1C goal of 6.5% or less for most patients. According to the report, in California alone, more than one-third of people with type 2 diabetes who were analyzed in the study were not in control of their blood sugar. The A1C test measures a person’s average blood sugar levels over the previous two to three months. The A1C test complements blood sugar monitoring that patients do on their own, which shows a blood sugar level at the time the test is taken.
“Making the decision to take control of the disease is one of the most important things a person with type 2 diabetes can do to properly manage the condition and ultimately reduce the risk of long-term complications associated with the disease,” said Dr. Michael Bush, Past Clinical Chief, Division of Endocrinology, Cedars-Sinai Medical Center. “The 6.5 Steps Toward Better Blood Sugar Control provide patients with recommendations that they can realistically incorporate into their daily routine. It’s a great tool to motivate patients to partner with their doctor or other healthcare professional to make better health choices and bring their blood sugar levels under control.”
Approximately 1,769,850 people in California are diagnosed with diabetes, and over 18 million people in the United States have type 2 diabetes, the most common form of diabetes. Type 2 diabetes occurs when the body does not produce enough insulin or does not respond properly to its own natural insulin, a condition called insulin resistance. Insulin helps the cells convert blood sugar to energy. When sugar builds up in the blood instead of going into the cells, it can starve the cells of energy and, over time, high blood sugar levels can cause diabetes-related complications, affecting the eyes, kidneys, nerves or heart.
Free Educational Materials and Sweepstakes
Anyone interested in learning more about better diabetes management can call 1-877-6-5-STEPS or visit http://www.stepitupdiabetes.com. People with type 2 diabetes can also sign up online to enter a free sweepstakes and become eligible to receive great prizes, including one-on-one telephone coaching with Bob Harper and a year-long gym membership.
The 6.5 Steps Toward Better Blood Sugar Control
The following abbreviated version of the 6.5 Steps Toward Better Blood Sugar Control is the centerpiece of AACE’s newly launched national diabetes educational campaign Diabetes & You: Step It Up to Get It Down, designed to help type 2 diabetes patients better manage their disease.
1. Be honest with yourself. Diabetes can be tough, but it doesn’t have to control you.
2. Think about your reasons for living a healthier life and feeling better. Always keep them in mind.
3. Team up with your doctor or other healthcare professional to make a plan. This plan may include taking one or more medicines. You are in this together with the same goals.
4. Make healthy eating and regular physical activity part of your life.
5. Check your blood sugar as often as your doctor tells you and know your A1C number. A1C is your average blood sugar level for the past 2 to 3 months.
6. No quitting. Not today. Not tomorrow. Never give up!
6.5. The HALF STEP – Getting started is HALF the battle!!!
To view the expanded version of the 6.5 Steps Toward Better Blood Sugar Control, visit http://www.stepitupdiabetes.com.
The Diabetes & You: Step It Up to Get It Down Expert Panel
AACE convened a panel of experts for a diabetes summit meeting in New York City to discuss the current state of diabetes management and develop the 6.5 Steps. Members of the expert panel include:
— Bob Harper, life and fitness coach from NBC’s “The Biggest Loser”
— Paul S. Jellinger, MD, MACE, Past President, American College of Endocrinology and Past President, American Association of Clinical Endocrinologists
— Fred A. Williams, Jr., MD, FACP, FACE, National Chair, Public and Media Relations Committee, American Association of Clinical Endocrinologists
— Mary M. Austin, MA, RD, CDE, Immediate Past President, American Association of Diabetes Educators
About the Campaign Sponsors
AACE is a professional medical organization consisting of over 5,300 practicing clinical endocrinologists devoted to furthering patient care in the field of endocrinology. AACE is committed to transforming the lives of patients by enabling one another to practice leading edge, proactive, ethical and cost effective medicine.
All members of AACE are fully licensed physicians and fully trained in endocrinology. The majority are board certified in internal medicine and subspecialty certified in adult or pediatric endocrinology. AACE members are recognized clinicians and educators, and many are affiliated with medical schools and universities. Members contribute on a regular and continuing basis to the scientific literature on endocrine diseases and conduct medical education programs on this subject.
For more information on AACE, please visit http://www.aace.com or http://www.powerofprevention.com.
GlaxoSmithKline has provided funding and other support to AACE for the Diabetes & You: Step It Up to Get It Down campaign. 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.
GlaxoSmithKline
http://www.aace.com
Add comment March 7, 2007
Discrimination Contributes To African-American Health Disparities
The experience of racial discrimination may be a key factor in explaining why African Americans have higher rates of obesity and suffer at higher rates from such diseases as diabetes and cardiovascular disorders, according to UCLA researchers.
Repeated responses to such discrimination — which include elevated blood pressure and heart rate — can cause enormous stress on a person’s mental and physical health, according to research scheduled to be published in Volume 58 of the Annual Review of Psychology.
Race-based discrimination may help explain why African Americans, despite gains in civil rights and targeted health programs, continue to have the highest rates of diabetes, cardiovascular heart disease, hypertension and stroke as compared to all other racial or ethnic groups in the United States.
“This is not to say that every African American has poor health,” said Vickie Mays, the report’s lead author, a UCLA professor of psychology and health services and director of the Center for Research, Education, Training and Strategic Communication on Minority Health Disparities. “However, African Americans — as a group of people — have not been able to gain as much ground as other ethnic groups. That’s when you need to worry and look at missing factors that can explain these health disparities.”
When a person experiences discrimination, the body develops a cognitive response in which it recognizes the discrimination as something that is bad and should be defended against, Mays said. She said this response occurs for the most part even if the person merely perceives that discrimination is a possibility.
Starting with the brain’s recognition of discrimination, the body sets into motion a series of physiological responses to protect itself from these stressful negative experiences, Mays said. These physiological responses include biochemical reactions, hyper-vigilance and elevated blood pressure and heart rate. With many African Americans, these responses may occur so frequently that they eventually result in the physiological system not working correctly.
According to Mays, the experience of race-based discrimination for some African Americans is akin to the response a person’s body mounts when it experiences significant life-threatening danger, such as fear for a person’s life or of a possible attack. She said that if the body mounts a response to protect itself against a “life-threatening” experience on a regular basis, after awhile it is strained and overworked. Many of the chemicals that come to its rescue can damage systems in the body that are associated with disease and obesity.
According to the report’s authors, there has been much focus on the emotional impact of discrimination. But other critical factors — such as identifying how the brain recognizes and determines what racial discrimination is and how the body responds biochemically — may help researchers understand why African Americans are not benefiting from protections against negative health outcomes in the same manner as whites.
Health disparities in African Americans may even be passed down from one generation to the next. For example, even middle- and upper-class African American women are at a higher risk of delivering pre-term babies as compared to other ethnic minority and white women of the same social class.
“What may be occurring is that despite having a great education and prenatal care, your body may be programmed to deliver early because of the stresses experienced by your mother during her pregnancy,” Mays said. Research suggests that African American women produce a hormone activated in response to stress that is often associated as a time-clock for birth.
“This results in the placenta separating itself a little bit early and, that may be one of the reasons for a preterm delivery,” Mays said.
Another key factor is that African Americans faced with constant discrimination may experience high levels of stress that cause an “allostatic load.” The term refers to the cumulative wear and tear of stress as the body responds to an overload of challenges and demands.
When the stress challenge to the cardiovascular system is prolonged and excessive to the point of allostasis, the immune system is suppressed, blood pressure increases and, over time, atherosclerosis can develop, resulting in coronary vascular disease.
UCLA researchers will conduct further research on the link between race-based discrimination and health problems, including searching for possible solutions and coping methods for individuals.
“As we deal with skyrocketing rates of obesity and rising rates of diabetes in African Americans and other racial and ethnic minority groups, we need to think about the impact of race-based discrimination and how they respond to that stress,” Mays said. “It may not be just a matter of telling a person to eat better or exercise. We may need to take a look at the person’s environment and the race-based discrimination that that person is experiencing.”
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The report was co-authored by Susan D. Cochran, UCLA professor of epidemiology and statistics, and Namdi W. Barnes, a staff member of the Center for Research, Education, Training and Strategic Communication on Minority Health Disparities.
It was funded by the National Institute of Health’s National Center on Minority Health and Health Disparities and the National Institute on Drug Abuse.
More information about Mays’ center is at http://www.minorityhealthdisparities.org/.
California’s largest university, UCLA enrolls approximately 38,000 students per year and offers degrees from the UCLA College of Letters and Science and 11 professional schools in dozens of varied disciplines. UCLA consistently ranks among the top five universities and colleges nationwide in total research-and-development spending, receiving more than $820 million a year in competitively awarded federal and state grants and contracts. For every $1 state taxpayers invest in UCLA, the university generates almost $9 in economic activity, resulting in an annual $6 billion economic impact on the Greater Los Angeles region. The university’s health care network treats 450,000 patients per year. UCLA employs more than 27,000 faculty and staff, has more than 350,000 living alumni and has been home to five Nobel Prize recipients.
Contact: Letisia Marquez
University of California – Los Angeles
Add comment March 7, 2007
Red Wine May Offset Effects Of High Calorie Diet
Red wine and red grapes contain a chemical, called resveratrol, that can offset some of the effects of gluttony, say researchers from the National Institute on Aging, Harvard Medical School, USA. Resveratrol does not seem to be able to get rid of the obesity, but it can lower glucose levels, help your liver and improve your heart.
You can read about this study in the journal Nature.
Studies had already indicated that resveratrol slows down the aging process in some non-mammalian animals. In this study, the scientists wanted to see what the effects of resveratrol might be on mammals.
They had lab rats which were fed 60% calories coming from fat. The rats were obese, had insulin resistance and cardiovascular diseases. The rats were divided into two groups. One group continued to eat 60% of calories from fat, while the other group had the same diet, but with resveratrol added to it.
The rats receiving resveratrol had lower glucose levels, their hearts became healthier, as did their liver tissue. The scientists also noticed that the rats that consumed resveratrol were more nimble on their feet, compared to the other group.
Even though the resveratrol-fed mice did not lose any weight, their health became as good as that of a mouse on a normal diet. Although the non-resveratrol fed mice continued to have a short lifespan, the resveratrol-fed mice lived as long as mice on a normal diet.
The scientists believe resveratrol may activate SIRT1, a gene associated with longevity.
If what happened to the mice could happen to humans, resveratrol could help prevent obese people from developing Type 2 Diabetes, heart disease, cancer and some other illnesses, say the researchers.
Comment by Editor of Medical News Today
Obesity is something people try to avoid for two reasons. Vanity, and/or health. If we find an ingredient that takes away the health risk, I wonder what most of us would eventually look like.
Would we continue the vanity drive, and then stuff ourselves after committing to a lifetime partner (try to look good only while you are single)?
How many of us would start feasting regularly as soon as the health risk was gone? I suspect I would – that is why I go to the gym everyday; so that I can burn lots of calories and allow myself a few more treats. Would I stop going to the gym? I really don’t know.
Would I eat more, or chose that steaming chocolate pudding with lashes of cream, rather than the fruit salad? I think I probably would.
“Resveratrol improves health and survival of mice on a high-calorie diet”
Joseph A. Baur, Kevin J. Pearson, Nathan L. Price, Hamish A. Jamieson, Carles Lerin8, Avash Kalra, Vinayakumar V. Prabhu, Joanne S. Allard, Guillermo Lopez-Lluch9, Kaitlyn Lewis, Paul J. Pistell, Suresh Poosala, Kevin G. Becker, Olivier Boss, Dana Gwinn, Mingyi Wang, Sharan Ramaswamy, Kenneth W. Fishbein, Richard G. Spencer, Edward G. Lakatta, David Le Couteur, Reuben J. Shaw, Placido Navas, Pere Puigserver, Donald K. Ingram, Rafael de Cabo and David A. Sinclair
Nature doi:10.1038/nature05354
Click here to view abstract online
Written by: Christian Nordqvist
Editor: Medical News Today
Add comment March 7, 2007
Abbott Reports Positive Subset Results For XIENCE™ V In Tough-to-treat Diabetic Patients
A subset analysis of diabetic patients in the SPIRIT II Clinical trial of the XIENCE™ V Everolimus Eluting Stent System showed nearly identical rates of in-stent late loss at six months in diabetic patients as those observed in the overall study patient population, according to new results presented today. Abbott also presented new positive nine-month safety data from the SPIRIT II trial, which showed no additional occurrences of MACE (Major Adverse Cardiac Event) or stent thrombosis between six and nine months.
Overall six-month data from SPIRIT II, which demonstrated that the XIENCE V system is statistically superior to Boston Scientific’s TAXUS® Paclitaxel-Eluting Coronary Stent System as measured by its primary endpoint of in-stent late loss, was presented last month at the World Congress of Cardiology in Barcelona.
Late loss is a measure of the change in the vessel diameter between the time immediately following stent placement and at six months.
“Diabetic patients present many challenges because of their higher rate of restenosis after treatment,” said Prof. Patrick W. Serruys, M.D., of the Thoraxcenter, Erasmus University Hospital, Rotterdam, and principal investigator of the SPIRIT II clinical trial. “These subgroup results are highly encouraging for difficult-to-treat patients.”
In-stent late loss in the diabetic subgroup analysis was 0.15 mm for XIENCE V vs. 0.39 mm for TAXUS. This is comparable to the overall six-month SPIRIT II study results, which showed late loss of 0.11 mm for XIENCE V and 0.36 mm for TAXUS.
“We believe these results have the potential to differentiate XIENCE V for physicians with patients whose cases present more challenges for treatment,” added John M. Capek, Ph.D., president, Cardiac Therapies, Abbott Vascular. “These data, in addition to the very positive feedback we’ve received from physicians since the recent launch of XIENCE V in Europe, further substantiate our excitement in bringing this product to our physician customers.”
SPIRIT II Clinical Nine-Month Follow-Up Safety Data
Confirming the six-month clinical data recently reported by Abbott, XIENCE V showed low rates of MACE (2.8 percent) and stent thrombosis (0.5 percent) after nine months. There were no additional occurrences of MACE or stent thrombosis between six and nine months.
Results were presented at the Cardiovascular Research Foundation’s 18th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.
XIENCE V has received a CE mark in Europe and is currently an investigational device in the United States and Japan. The system utilizes everolimus, which has been shown to reduce tissue growth in the coronary vessels following stent implantation, and is based upon the highly deliverable and proven MULTI-LINK VISION® coronary stent platform.
About the SPIRIT Family of Trials
The SPIRIT FIRST study of the XIENCE V Stent System showed positive results through two years with no additional MACE events between one and two years. SPIRIT II is a 300-patient study conducted in Europe and Asia Pacific. SPIRIT III is a large-scale pivotal clinical trial comparing XIENCE V to the TAXUS® Paclitaxel-Eluting Coronary Stent System in the United States and Japan. SPIRIT IV, which is currently enrolling patients, will evaluate the safety and efficacy of XIENCE V for the treatment of coronary artery disease in a more complex patient population in the United States. SPIRIT V is an international clinical trial that will provide additional clinical experience with XIENCE V in approximately 3,000 patients at 100 clinical sites throughout Europe, Asia, Canada and Latin America. Twelve-month results from SPIRIT II and additional nine-month results from SPIRIT III will be presented in the first half of 2007.
About Abbott’s Drug-Eluting Stent Program
Abbott’s drug-eluting stent is the XIENCE™ V Everolimus Eluting Coronary Stent System, which the company launched in Europe earlier this month. In April 2006, Abbott acquired the vascular intervention and endovascular solutions businesses of Guidant Corporation – the U.S. market leader in metallic stents since the introduction of the company’s first stent system in 1997.
About Abbott Vascular
Abbott Vascular, a division of Abbott, is one of the world’s leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Headquartered in Northern California, Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products that are recognized internationally for their safety, effectiveness and ease of use in treating patients with vascular disease.
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 65,000 people and markets its products in more than 130 countries.
Abbott
http://www.abbott.com/
Add comment March 7, 2007
A Call To Action For People With Diabetes: Take Steps To Lower Your Risk For Heart Disease
People with diabetes must closely manage their blood glucose, blood pressure and cholesterol levels, or face a significantly increased risk of cardiovascular disease, say three leading health organizations. Research has shown that two out of three people with diabetes die from a heart attack or stroke, making cardiovascular disease the number one killer of people with diabetes. The American Diabetes Association (ADA), the American College of Cardiology (ACC) and the National Diabetes Education Program (NDEP) are collaborating during November — American Diabetes Month — to emphasize the critical link between diabetes and related cardiovascular complications.
In particular, tight control of blood glucose can significantly reduce the likelihood of a heart attack or stroke in people with diabetes, according to data from a study commissioned by the National Institutes of Health (NIH). The Epidemiology of Diabetes Interventions and Complications (EDIC) study was a follow-up to NIH’s Diabetes Control and Complications Trial (DCCT) on people with type 1 diabetes, conducted from 1983 to 1989. Results from the EDIC study showed that intensive control of blood glucose in patients with diabetes reduced the risk of heart attacks and stroke by more than 50 percent. Experts agree that this finding adds to a strong and growing body of evidence that everyone with diabetes — whether it is type 1 or type 2 diabetes — gains from blood glucose control.
Unfortunately, data from the Centers for Disease Control and Prevention (CDC) suggest that fewer than 50 percent of Americans with diabetes are reaching the level of glucose control recommended by the ADA, which is an A1C level of less than seven percent. This alarming trend contributes to the disproportionate number of people with diabetes who experience cardiovascular events, such as a heart attack or stroke.
“For most people with diabetes, keeping blood glucose under tight control isn’t easy — but the benefits of control are indisputable,” said John Buse, MD, PhD, President-Elect, Medicine & Science, of the American Diabetes Association. “Controlling blood glucose, along with blood pressure and cholesterol, can help save not only a person’s heart, eyesight and limbs, but a person’s life. It’s what we call the ABCs of diabetes.”
In addition to tight blood glucose control, people with diabetes need to manage other risk factors for cardiovascular disease, such as blood pressure and cholesterol levels. In fact, it is estimated that approximately 73 percent of adults with diabetes have high blood pressure and most have cholesterol levels that put them at increased risk for cardiovascular disease.
“It is clear that we all need to work harder to help people with diabetes manage their ABCs,” said Griffin P. Rodgers, M.D., M.A.C.P., Acting Director of the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. “The truly amazing news from the EDIC study is that more than a decade after they left the DCCT and returned to the care of their own doctors, participants are still benefiting from the relatively brief period of intense blood glucose control they had during the study, and they continue to have significantly lower risks for cardiovascular disease, as well as retinopathy, nephropathy, and neuropathy.”
Together, ADA, ACC and NDEP are urging patients to talk with their health care providers about managing the “ABCs of Diabetes.” For most people with diabetes the goals are:
— A1C (measures average blood glucose over the past 2 to 3 months): less than 7 percent. Check at least twice a year.
— Blood pressure: below 130/80. Check at every doctor’s visit.
— Cholesterol (LDL): below 100. Check at least once a year.
The groups offer the following advice to help manage blood glucose, blood pressure, and cholesterol: make wise food choices, engage in daily physical activity and take prescribed medications. People with diabetes should also avoid smoking and consult their health providers about taking aspirin.
ADA and ACC have developed a diabetes survival guide called “Choose to Live” to give people with diabetes information they need to help reduce diabetes-related complications such as heart disease and stroke. Contact the ADA at 1-800-DIABETES or visit http://www.diabetes.org for a free copy. NDEP promotes its Control Your Diabetes. For Life. campaign, which offers materials with ideas for sticking to a healthy eating plan, ways to stay active with regular physical activity, and other tips for feeling better and staying healthy. Contact NDEP at http://www.ndep.nih.gov or at 1-800-438-5383. Educational materials are available in English, Spanish and 15 Asian and Pacific Islander languages.
The American Diabetes Association is the nation’s leading voluntary health organization supporting diabetes research, information and advocacy. Founded in 1940, the Association has offices in every region of the country, providing services to hundreds of communities.
The American College of Cardiology, a 34,000-member nonprofit professional medical society and teaching institution, is the leading organization dedicated to advocating for quality cardiovascular care.
The National Diabetes Education Program, the leading federal government source of information about diabetes prevention and control, is sponsored by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) and 200 public and private partners.
American Diabetes Association
http://www.diabetes.org
Add comment March 7, 2007
Akesis Pharmaceuticals Manufactures Drug Product For Clinical Trials In Type 2 Diabetes
Akesis Pharmaceuticals, Inc. (OTC Bulletin Board: AKES.OB) today announced that it has completed manufacturing of several lots of its proprietary combination drug candidate AKP-101 through its manufacturing partner, Douglas Laboratories of Pittsburgh, PA, to support the initiation of new clinical trials in type 2 diabetes. Akesis is designing a double-blind placebo controlled trial to evaluate the effectiveness of AKP-101, in combination with metformin, in lowering and controlling blood glucose levels in type 2 diabetes patients.
Akesis holds numerous issued patents and patent applications relating to the use of chromium, vanadium and other components with metformin, sulfonylureas, and other classes of diabetic agents. In an open-label study, Akesis demonstrated significant reductions in glycated hemoglobin (HbA1c) levels in subjects with type 2 diabetes when administering one of its products in combination with metformin and sulfonylureas.
“This achievement represents an important step toward our goal of bringing to market improved therapies for individuals with type 2 diabetes,” said Akesis president and CEO Jay Lichter, Ph.D. “Our manufactured drug product was made under cGMP guidelines and is suitable for our upcoming trial.”
About Akesis:
Akesis is a pharmaceutical company with a portfolio of innovative prospective treatments for diabetes and other related metabolic disorders. The company possesses issued U.S. patents for both prescription and over-the- counter treatments, which uniquely combine anti-diabetic trace minerals with certain classes of diabetes oral agents. Akesis’ products have demonstrated utility in lowering and controlling blood glucose levels in patients with type 2 diabetes. Blood sugar control via oral drugs represents a multi billion- dollar industry in the United States.
Note regarding forward-looking statements:
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Akesis Pharmaceuticals disclaims any intent or obligation to update these forward- looking statements, and claims the protection of the Safe Harbor for forward- looking statements contained in the Act. Examples of such statements include, but are not limited to, any plans to initiate clinical trials or to otherwise seek to confirm the utility of the company’s products, and the suitability of these products for clinical trials. Such statements are based on management’s current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the inability to raise additional capital, an amount of which is required to support completion of new clinical trials, difficulties or delays in development, testing, regulatory approval, production and marketing of the company’s drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the company’s drug candidates that could slow or prevent clinical development, and product approval or market acceptance (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials). For additional information about risks and uncertainties Akesis faces, see documents Akesis files with the Securities and Exchange Commission, including the report on Form 10-K for the fiscal year ended December 31, 2005, and all our quarterly and other periodic SEC filings. Akesis has not yet submitted any formulations to the Food and Drug Administration for review. The FDA has not made any determinations with regard to Akesis’ proposed formulations. Akesis does not, at this time, manufacture or offer products for sale.
Akesis Pharmaceuticals, Inc.
http://www.trubion.com/
Add comment March 7, 2007
Sugar-Control In Type II Diabetes May Be Improved With Herbal Medicine Silymarin
Diabetes is a growing health problem. Giving antioxidants is recognised as one way of helping people with diabetes to control their blood sugar levels.
The herbal medicine extracted from seeds of the Milk Thistle, Silybum marianum (silymarin) is known to have antioxidant properties and research published this week in Phytotherapy Research shows that this extract can help people significantly lower the amount of sugar bound to haemoglobin in blood, as well as reducing fasting blood sugar levels.
Silymarin contains a number of active constituents called flavolignans which are also used to help protect the liver from poisoning.
“We don’t know the exact mechanism of action for this effect, but this work shows that silymarin could play an important role in treating type II diabetes,” says lead author Fallah Huseini, who works at the Institute of Medicinal Plants, which is based in Tehran, Iran.
The data came from a randomized double-blind clinical trial involving 51 people who had had type II diabetes for at least 2 years. One group of 25 patients received 200 mg of silymarin three times a day for 4 months, while the remaining 26 received a placebo treatment. All of the patients continued to use conventional oral hypoglycaemic treatment during the trial. Patients were examined at monthly intervals.
Compared with the beginning of the trial, the treatment group had a significant reduction in fasting blood glucose levels (p
“The results are very encouraging, and we now need to do further large multi-centre studies,” says Huseini.
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Huseini, H.F: The Efficacy of Silybum marianum (L.) Gaertn. (Silymarin) in the Treatment of Type II Diabetes: A Randomized, Double-blind, Placebo-controlled, Clinical Trial
Phytotherapy Research is an international journal for the publication of original medicinal plant research, focussing on pharmacology, toxicology and the clinical applications of herbs and natural products in medicine. Papers concerned with the effects of common food ingredients and standardised plant extracts, including commercial products, and mechanistic studies on isolated natural products are particularly welcome. Papers and communications range from case studies to full clinical trials, including studies of herb-drug interactions and other aspects of the safety of herbal medicines. Phytotherapy Research can be accessed online at: http://www.interscience.wiley.com/journal/ptr
John Wiley & Sons Ltd., with its headquarters in Chichester, England, is the largest subsidiary of John Wiley & Sons, Inc. Founded in 1807, John Wiley & Sons, Inc., provides must-have content and services to customers worldwide. Its core businesses include scientific, technical, and medical journals, encyclopaedias, books, and online products and services; professional and consumer books and subscription services; and educational materials for undergraduate and graduate students and lifelong learners. Wiley has publishing, marketing, and distribution centres in the United States, Canada, Europe, Asia, and Australia. The company is listed on the New York Stock Exchange under the symbols JWa and JWb. Wiley’s Internet site can be accessed at http://www.wileyeurope.com/
Contact: Polly Young
John Wiley & Sons, Inc.
Add comment March 7, 2007