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

多中心兰德、安慰剂对照、DBL 盲试验 - 二甲双胍治疗肥胖青少年

• 批准号: 7374968
• 负责人: WILLIAM J KLISH
• 金额: $ 2.57万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7374968
• 关键词: MULTI; CENTER; RAND; PLACEBO; CTRL

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.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心机构，不一定为研究者机构。本试验将检验以下假设：在肥胖青少年中，与接受安慰剂治疗和相同生活方式干预的受试者相比，使用缓释Metastatin（glucophage XR）治疗加上生活方式干预将导致肥胖减少（通过体重指数[BMI]测量）。在全国范围内，76例受试者（当地，21例受试者）将被随机分配至二甲双胍（治疗）组或对照（安慰剂）组。将在全国范围内筛选约135例受试者（35例在当地）。本研究设计为随机、双盲、安慰剂对照、多中心临床试验。受试者将平均分配至两组：二甲双胍组和对照组。我们预计需要52周的时间招募受试者进入本研究。一旦入组，受试者将参加为期四周的阶段运行。在初始导入期后，受试者将被随机分配至两个治疗组之一，进行48周治疗期。治疗期结束后，受试者将停用研究药物/安慰剂，并进入为期48周的随访期。因此，单个受试者参与研究的总时间将为100周，总研究持续时间将为152周。将对受试者进行人体测量、体脂测量（DEXA和MRI）和生化随访。