Glaser Obesity Study
Recruitment status was Active, not recruiting
This study will determine if the drug metformin, coupled with diet and exercise counseling, will help obese adolescents lose weight.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Multi-Center, Randomized, Placebo Controlled, Double Blind Trial of Metformin in Obese Adolescents.|
- The primary outcome measure that will be used to test the study hypothesis is change in Body Mass Index (BMI). The mean change from baseline in individual BMIs between the two groups will be compared at two time-points; at week 52 and week 100.
|Study Start Date:||October 2003|
|Estimated Study Completion Date:||November 2007|
America is facing an epidemic of obesity among its youth. In the last seven years, there has been a 50% increase in the prevalence of obesity as defined by a Body Mass Index (BMI) > 30 kg/m². For the morbidly obese adult, which is defined as having a BMI > 35 kg/m², mortality is increased by 152 to 279%. In a Veterans Administration study of obese 25-34 year old males, there was a 13-fold excess mortality rate over 7½ years.
As in adults, risks associated with childhood and adolescent obesity include elevated blood pressure and cholesterol levels, predisposing these individuals to cardiovascular disease. In addition, a significant number of obese youth have abnormally high concentrations of insulin, with an attendant increased risk of developing type 2 diabetes mellitus.
Currently, limited options are available to help such individuals. While attempts at lifestyle change (e.g., altering diet and activity level) may have some success in the short term, attempts at maintaining weight loss over the long term often fail. Furthermore, there are no current medications that will safely induce significant weight loss over time.
Metformin is an oral antihyperglycemic, insulin-sensitizing agent that has been used in many countries for treatment of type 2 diabetes for more than 40 years. In March 1995, it was approved by the Food and Drug Administration for the treatment of adult type 2 diabetes. Metformin improves insulin sensitivity and reduces insulin resistance by hepatic and peripheral actions. It does not increase insulin secretion.
Further, metformin decreases hepatic glucose production and results in weight loss. Compared to available drugs that act similarly, only metformin has weight-lowering activity, perhaps by increasing nitric oxide production and improving insulin sensitivity. It is also possible that the mild gastrointestinal side effects of metformin induce weight loss. Metformin is therefore often the agent of choice in obese, type 2 diabetics. In a study of non-diabetic obese adults, treatment with metformin resulted in decreased food intake, and decreased body weight and fat.
This is a randomized, double blind, placebo controlled, multi-center clinical trial. The primary outcome measure that will be used to test the study hypothesis is change in BMI from week 0 to week 52, as well as change in BMI from week 0 to week 100. Approximately 135 potential subjects will be screened at the participating institutions, and an expected 76 subjects will be randomized into the study.
|United States, California|
|University of California, Los Angeles|
|Los Angeles, California, United States, 90095|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Stanford, California, United States, 94305|
|United States, Massachusetts|
|Children's Hospital, Boston|
|Boston, Massachusetts, United States, 02115|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Darrell M Wilson, MD||Stanford University|