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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。该试验将验证肥胖青少年的假设，即与接受安慰剂治疗和相同生活方式干预的受试者相比，接受延长释放二甲双胍（glucophage XR）治疗，加上生活方式干预，将导致肥胖（以体重指数[BMI]衡量）减少。在全国范围内，76名受试者（当地21名受试者）将被随机分为二甲双胍（治疗）组或对照组（安慰剂）组。全国将筛选约135名受试者（当地筛选35名）。本研究设计为随机、双盲、安慰剂对照、多中心临床试验。受试者将被平均分为两组：二甲双胍组和对照组。我们预计需要52周的时间来招募受试者参加这项研究。一旦注册，受试者将参加为期四周的分阶段运行。在初始阶段运行后，受试者将被随机分配到两组中的一组进行为期48周的治疗阶段。治疗期结束后，受试者将停止服用研究药物/安慰剂，进入48周的随访期。因此，单个受试者参与研究的总时间为100周，总研究时间为152周。受试者将接受人体测量、体脂测量（DEXA和MRI）和生化测量。

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.