VBLOC Weight-loss Therapy, A Clinical Research Study By Stanford

Stanford researchers are conducting a national study to test a new weight-loss therapy,VBLOC that interfere with the nerves that tell people when they're hungry and in control how the body stores fat.Carrying extra weight is a real cause for concern. Overweight and obesity are risk factors for a number of diseases, including Type 2 diabetes (diabetes mellitus), high cholesterol, hypertension, osteoarthritis, obesity-related cardiomyopathy and perhaps even some forms of cancer (breast, colorectal, endometrial and kidney).

Although successful, long-term weight loss still requires a commitment to modifying lifestyle behaviors, there may be more you can do to empower healthy weight loss.

Unlike other types of bariatric surgery (laparoscopic banding or gastric bypass,) that alter the stomach’s anatomy, VBLOC Therapy is delivered by an implantable, investigational device intended to block signals carried on the vagus nerve between the brain and the digestive system that control sensations of hunger, satisfaction and fullness.

The device itself uses laparoscopically-implanted electrodes that deliver high-frequency, low-energy electrical impulses to block the signals conveyed through the vagal nerves. By being able to reversibly control these signals, VBLOC Therapy may aid in weight loss.

VBLOC Therapy includes both external and implanted components. VBLOC Therapy may be turned off and is designed to be reversible, programmable and non-invasively adjustable.

The EMPOWER clinical research study is now enrolling patients to evaluate the safety and effectiveness of the investigational device that delivers VBLOC Therapy.

Who Is a Candidate for Clinical Trials of VBLOC Therapy?

Individuals may be considered for participation in Clinical Trials of VBLOC Therapy if they:

• Have a Body Mass Index (BMI) of 40 to 45, or of 35 or greater and also suffer from at least one obesity related condition or co-morbidity such as diabetes, high blood pressure, high cholesterol or sleep apnea.
• Have completed at least six months of a supervised weight loss program and have failed to lose weight or to maintain weight loss.

For more information about VBLOC Therapy and the EMPOWER clinical research study, please call the nurse-staffed information line at 1-866-291-9146 Monday–Thursday, 7 a.m.–7 p.m. and Friday, 7 a.m.–6 p.m., CST.

CAUTION: Investigational device. Limited by Federal law to investigational use.

tag: Weight-loss, Weight Control, VBLOC Therapy, EMPOWER clinical research study, Body Mass Index, laparoscopic banding, gastric bypass, bariatric surgery

Weight Loss, Maintain It With Group Sessions and Counseling.

COLORADO SPRINGS, Colo., March 11 — People who shed weight and want to keep it off might benefit from monthly personal contact interventions, researchers reported at the American Heart Association’s Conference on Nutrition, Physical Activity and Metabolism.

Results of the study will also be simultaneously published in the Journal of the American Medical Association.

In a test of three ways that might help people maintain weight loss, those who received monthly personal counseling were best at keeping off unwanted pounds. Overall, 42 percent of the study members maintained at least a 4-kilogram (9-pound) weight loss for 30 months.

“We know how to help people lose weight in a healthy way, but we know very little about how to help them to keep the weight off,” said Laura P. Svetkey, M.D, lead author of the study and professor of medicine at Duke University Medical Center in Durham, N.C. “This study is the longest and largest to test strategies for long-term weight loss maintenance, and it suggests that long-term weight control is an achievable goal.

“The United States is in the midst of an obesity epidemic, one that portends serious future health consequences. Overweight and obesity are the leading cause of high blood pressure, diabetes and abnormal cholesterol, which are leading causes of cardiovascular disease, which is, in turn, the leading cause of death in this country,” Svetkey said. “So if we really want to get to the root causes of these disorders, we need to address the obesity epidemic.”

Despite the importance of obesity control, few studies have tested strategies to maintain weight loss over long periods.

Svetkey and her colleagues enrolled 1,685 participants in the two-phase Weight Loss Maintenance trial, which was conducted at four clinical centers in the United States.

Phase I consisted of 20 weekly group sessions of 18-25 participants held over six months, during which trained counselors emphasized three key elements to weight loss — consuming fewer calories, increasing moderate physical activity, and eating a healthy diet. Researchers recommended DASH (Dietary Approaches to Stop Hypertension), a diet rich in fruits, vegetables, whole-grain and high fiber foods, that uses low-fat and fat-free dairy products and is low in total and saturated fat and sodium. DASH lowers blood pressure and cholesterol even without weight loss.

Counselors helped participants use tools like self-monitoring and goal-setting, and helped them remember why they wanted to lose weight in the first place. The group sessions also provided study members with social support from other participants.

At the end of Phase I, 61 percent of the participants in the trial were eligible for Phase II, which lasted for 30 months, because they had lost at least nine pounds and as much as 66 pounds.

Thirty-eight percent of people in Phase II were African-American and 37 percent were male. “This is important because men are often underrepresented in weight loss studies, and obesity disproportionately affects African Americans,” Svetkey said.

Researchers randomly assigned the volunteers to one of three groups:

• Personal contact (PC) — Participants talked with an interventionist (monthly, nine times by telephone and three times face-to-face each year) who provided personal counseling and encouragement.
• Interactive technology (IT) — Study members had access to an interactive Web site on which they could record and track their exercise and calorie intake; set goals and monitor their progress toward them; and communicate with others in the IT group.
• Self-directed (SD) — Participants were urged to maintain their weight loss and then sent off without further intervention.
Results from the trial after 30 months included:
• Overall, 71 percent weighed less than when they began Phase I. The difference in the percentage of each group that weighed less was statistically significant — PC group (77 percent); IT group (69 percent) and SD group (67 percent).
• Thirty-seven percent of enrollees weighed at least 5 percent below their beginning weight. Again, the PC participants (42 percent) significantly out-performed those in the SD (34 percent) and IT (29 percent) groups.
• Among all study members, 32 percent weighed no more than 3 percent above their weight at randomization. However, differences between the three groups — SD (29 percent), IT (29 percent) and PC (36 percent) — were not significantly different statistically.
• Although at 24 months the average weight regained by the IT group was less than that of the SD arm, researchers found no difference between the two at 30 months.

“The effects we observed were modest,” Svetkey said. “The personal contact group regained about 3.3 pounds less than the self-directed group.”

Even a small weight loss can have potential health benefits, she noted.

“Each pound of weight loss can lower blood pressure by as much as a millimeter of mercury, and the more weight you lose, the bigger the blood pressure effect,” Svetkey said. “Each pound of weight loss is estimated to lower the risk of developing diabetes by 8 percent, which is quite impressive.

“Clearly more research is needed to refine these maintenance interventions to make them more effective, but this study is an important step in the right direction.”

The study was conducted at four clinical sites: Duke, Pennington Biomedical Research Center, Johns Hopkins University and the Kaiser Permanente Center for Health (CHR) Research, which also served as the coordinating center.

Co-authors are: Victor J. Stevens, Ph.D. (CHR Coordinating Center); Phillip J. Brantley, Ph.D. (Pennington); Lawrence J. Appel, M.D. (Hopkins); Jack F. Hollis, Ph.D. (CHR); Catherine M. Loria, Ph.D. (NHLBI); and William M. Vollmer, Ph.D.; Cristina M. Gullion, Ph.D.; and Kristine Funk, M.S. (all at the CHR coordinating center.)

The National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH) funded the study.

Statements and conclusions of abstract authors that are presented at American Heart Association/American Stroke Association scientific meetings are solely those of the abstract authors and do not necessarily reflect association policy or position. The associations make no representation or warranty as to their accuracy or reliability.

tag: Weight-loss, Weight loss, Nutrition, Physical Activity, Metabolism, obesity control, Dietary Approaches to Stop Hypertension, NHLBI, National Institutes of Health

Better Controll Of Insulin-resistant Type 2 Diabetes With Weight-loss and Lifestyle Change.

DALLAS — March 11, 2008 — Weight-loss and major lifestyle changes may be more effective than intensive insulin therapy for overweight patients with poorly controlled, insulin-resistant type 2 diabetes, according to a diabetes researcher at UT Southwestern Medical Center.

The National Heart, Lung, and Blood Institute of the National Institutes of Health recently halted part of an ongoing clinical trial on diabetes and heart disease after more than 250 people died while receiving intense treatment to drive their blood glucose levels below current clinical guidelines.

The evidence is compelling that when insulin levels are high, certain tissues are overloaded with fatty molecules, which leads to insulin resistance. And yet, the high blood glucose levels of many obese patients with insulin-resistant type 2 diabetes are being treated with increasing amounts of insulin in an attempt to overpower that resistance. While high doses of insulin may lower glucose levels, it will also increase the fatty molecules and may cause organ damage.
In a commentary in the March 12 issue of The Journal of the American Medical Association, Dr. Roger Unger, professor of internal medicine, wrote about the recent findings of his own and other labs that link insulin resistance to excess accumulation of fatty molecules in liver and muscle.

Dr. Unger, who has investigated diabetes, obesity and insulin resistance for more than 50 years said intensive insulin therapy is contraindicated for obese patients with insulin-resistant type 2 diabetes because it increases the fatty acids that cause diabetes. Instead, the most rational therapy eliminates excess calories, thereby reducing the amount of insulin in the blood and the synthesis of the fatty acids stimulated by the high insulin. Giving more insulin simply increases body fat.

“Evolution was unprepared for the change in the American diet to processed fast food and drive-through lanes,” he said. “There’s no way that our genes could evolve to gird themselves against the superabundance of very, very high-calorie foods that have flooded the U.S.”

Before the discovery of insulin, starvation was the only treatment for diabetes, said Dr. Unger, who is a member of the National Academy of Sciences.

“Today there are many treatment options, including bariatric surgery, if necessary, to lower the fat content in the body before you start giving insulin,” he said. “The fat is causing insulin resistance and killing the insulin-producing beta cells in the pancreas — that is what is causing type 2 diabetes.”

Giving more insulin simply channels the glucose into fat production. There is now a spectrum of therapies that improve diabetes by correcting the insulin resistance by reducing the body fat. Insulin treatment would be indicated only if all these fail.

Dr. Unger said insulin should be given to patients with insulin deficiency, but not if the insulin levels are already very high but ineffective. “Giving more insulin to an insulin-resistant patient is akin to raising the blood pressure of a patient with high blood pressure to overcome resistance to blood flow. Instead, you would try to reduce the resistance,” he said.

In the commentary, Dr. Unger said the increase in the number of patients with insulin-resistant type 2 diabetes can be traced to the epidemic of obesity that began in the U.S. after World War II, when food preparation was moved from the family kitchen to factories and companies that produce high-fat, calorie-dense foods, leading both men and women to consume substantially more calories on a daily basis. In addition, technological advancements such as televisions, computers and automobiles reduced the number of calories burned per day.

Type 2 diabetes occurs when the body is unable to make enough of the hormone insulin to compensate for insulin resistance. The condition affects between 18 million and 20 million people in the U.S.

Factors that increase the risk of type 2 diabetes include obesity, age and lack of exercise. Over a period of years, high blood sugar damages nerves and blood vessels, leading to complications such as heart disease, stroke, blindness and kidney disease.

Dr. Unger’s research is supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases, the Department of Veterans Affairs, and the Juvenile Diabetes Research Foundation.

Visit http://www.utsouthwestern.edu/endocrinology to learn more about UT Southwestern’s clinical services in endocrinology.
tag: diabetes, Weight-loss, type 2 diabetes, insulin, bariatric surgery,