Activity and Metformin Intervention in Obese Adolescents
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to assess the sustainability of a two-year intervention aimed at improving body mass index (BMI) and metabolic and vascular health in obese youth. The study will compare lifestyle changes with diet and exercise alone with changes in lifestyle in combination with metformin medication. An initial intensive exercise program will also be compared with a standard exercise program. Hypothesis: Metformin therapy in combination with intensive lifestyle intervention in obese children and adolescents will be associated with reduced rate of weight gain, improved BMI, body composition, physical activity, physical fitness, insulin sensitivity, blood lipid profiles, adipocytokines and vascular function. |
|---|---|
| Condition | Obesity Type 2 Diabetes |
| Intervention | Drug: Metformin and standard exercise Drug: Metformin Intensive exercise Behavioral: Placebo Standard exercise Behavioral: Intensive exercise |
| Phase | Phase 4 |
| Sponsor | Lawson Health Research Institute |
| Responsible Party | Lawson Health Research Institute |
| ClinicalTrials.gov Identifier | NCT00934570 |
| First Received | July 6, 2009 |
| Last Updated | October 3, 2012 |
| Last verified | October 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | July 6, 2009 |
|---|---|
| Last Updated Date | October 3, 2012 |
| Start Date | April 2009 |
| Estimated Primary Completion Date | May 2012 |
| Current Primary Outcome Measures | Reduction in BMI [Time Frame: 2 years] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Improvement in physical activity [Time Frame: 2 years] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Activity and Metformin Intervention in Obese Adolescents |
|---|---|
| Official Title | Reduction of Adolescent Risk Factors for Type 2 Diabetes and Cardiovascular Disease |
| Brief Summary | The purpose of this study is to assess the sustainability of a two-year intervention aimed at improving body mass index (BMI) and metabolic and vascular health in obese youth. The study will compare lifestyle changes with diet and exercise alone with changes in lifestyle in combination with metformin medication. An initial intensive exercise program will also be compared with a standard exercise program. Hypothesis: Metformin therapy in combination with intensive lifestyle intervention in obese children and adolescents will be associated with reduced rate of weight gain, improved BMI, body composition, physical activity, physical fitness, insulin sensitivity, blood lipid profiles, adipocytokines and vascular function. |
| Detailed Description | This study will assess the sustainability of a two-year intervention and the degree of improvement in body mass index (BMI) and reduction in risk factors for type 2 diabetes and diabetes related cardiovascular disease, as well as evaluating the additive effect of metformin (as GlumetzaTM 500 mg Extended Release Tablets) and comparing an initial intensive exercise program with a standard exercise program. The study will recruit obese youth who are at risk for type 2 diabetes and cardiovascular disease. |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention |
| Condition |
|
| Intervention | Drug: Metformin and standard exercise Metformin 1500 mg daily for 2 years Other Names: GlumetzaTM 500 mg Extended ReleaseDrug: Metformin Intensive exercise Metformin 1500 mg daily for 2 years Other Names: GlumetzaTM 500 mg Extended ReleaseBehavioral: Placebo Standard exercise Standard exercise Behavioral: Intensive exercise Placebo Intensive exercise |
| Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 60 |
| Estimated Completion Date | May 2012 |
| Estimated Primary Completion Date | May 2012 |
| Eligibility Criteria | Inclusion Criteria: - Obese adolescents defined as BMI greater than the 95th percentile for age and gender - Metformin naive subjects Exclusion Criteria: - Elevated fasting plasma glucose ≥ 6.0 mmol/L - 2 hour plasma glucose ≥ 11.1 mmol/L after a standard glucose load - A1C > 6.0% - Medication other than "over the counter" drugs, oral contraceptive pill or thyroid hormone replacement - Smoking - Pregnancy - Renal insufficiency (serum creatinine > the upper limit of normal) - Hepatic dysfunction (> 1.5 times the upper limit of normal for AST and ALT) - Latex Allergy - Hypersensitivity to metformin or its ingredients - Breast feeding - Subjects with a history of lactic acidosis - Abnormal creatinine clearance - HIV, HBV, and HCV infections - Drug and alcohol abuse - Severe mental disorders - Subjects who are planning radiologic exams involving in i.v. injection of iodinated contract materials - Participation in another clinical trial - Significant history or presence of cardiovascular, pulmonary, gastrointestinal, immunologic, endocrine, neurologic disorders - Malignant diseases - Previous exposure to any pharmaceutical antidiabetic agent |
| Gender | Both |
| Ages | 10 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | Canada |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00934570 |
|---|---|
| Other Study ID Numbers | R-08-259 |
| Has Data Monitoring Committee | No |
| Information Provided By | Lawson Health Research Institute |
| Study Sponsor | Lawson Health Research Institute |
| Collaborators | Canadian Institutes of Health Research (CIHR) |
| Investigators | Principal Investigator: Cheril Clarson, MD Lawson Health Research Institute |
| Verification Date | October 2012 |
Locations[ + expand ][ + ]
| Children's Hospital, London Health Sciences Centre | London, Ontario, Canada, N6A 5W9 |
|---|