Glaser Obesity Study
Recruitment status was: Active, not recruiting
|First Submitted Date ICMJE||September 13, 2005|
|First Posted Date ICMJE||September 21, 2005|
|Last Update Posted Date||October 5, 2006|
|Start Date ICMJE||October 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00209482 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Glaser Obesity Study|
|Official Title ICMJE||A Multi-Center, Randomized, Placebo Controlled, Double Blind Trial of Metformin in Obese Adolescents.|
|Brief Summary||This study will determine if the drug metformin, coupled with diet and exercise counseling, will help obese adolescents lose weight.|
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Intervention ICMJE||Drug: glucophage XR|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Completion Date||November 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||13 Years to 18 Years (Child, Adult)|
|Accepts Healthy Volunteers||Not Provided|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00209482|
|Other Study ID Numbers ICMJE||GPRN410.PL2.02|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Glaser Pediatric Research Network|
|Collaborators ICMJE||Elizabeth Glaser Pediatric AIDS Foundation|
|PRS Account||Glaser Pediatric Research Network|
|Verification Date||November 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP