Obesity Clinical Trial
Official title:
Reduction of Adolescent Risk Factors for Type 2 Diabetes and Cardiovascular Disease
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.
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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