A MULTI-CENTER RAND, PLACEBO CTRL, DBL BLIND TRIAL - METFORMIN IN OBESE ADOLESCE

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This trial will test the hypothesis that among obese adolescents, treatment with extended release Metformin (glucophage XR), coupled with a lifestyle intervention, will result in decreased obesity (as measured by body mass index [BMI]) as compared to subjects who received treatment with placebo and the same lifestyle intervention. Nationally, 76 subjects (locally, 21 subjects) will be randomized into either the Metformin (treatment) group or the control (placebo) group. Approximately 135 subjects will be screened nationally (35 locally). This study is designed as a randomized, double blind, placebo controlled, multi-center clinical trial. Subjects will be evenly divided between the two arms: the Metformin group and the control group. We expect to take 52 weeks to enroll subjects into this study. Once enrolled, subjects will participate in a four-week run in phase. After the initial run in phase, subjects will be randomized into one of the two arms for the 48-week treatment phase. After the treatment phase, subjects will be taken off study drug/placebo and will enter the follow-up phase for 48 weeks. Thus, the total amount of time a single subject will be involved in the study will be 100 weeks and the total study duration will be 152 weeks. Subjects will be followed with anthropometry, with body fat measurements (DEXA and MRI), and biochemically.