TREATMENT OPTIONS FOR TYPE 2 DIABETES IN ADOLESCENTS AND YOUTH (TODAY)

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这是一项由NIH/NIDDK赞助的多中心、随机、对照的临床试验，旨在评估三种治疗儿童和青年2型糖尿病(T2 DM)方案的安全性和有效性。该方案由STOP-T2D(治疗或预防儿科2型糖尿病的研究)研究小组开发，将在13个临床中心实施。正在比较的三种治疗方案是：单独使用二甲双胍、二甲双胍+罗格列酮和二甲双胍+强化生活方式干预，目的是减轻7%-10%的体重。该方案的药物臂是双盲的，主要结果是在临床护理和安全所需的情况下通过揭秘来掩盖的。主要结果是“治疗失败”的时间(定义为HbA1c8%持续6个月或在没有胰岛素的情况下无法避免代谢失调)。次要结果包括：血糖控制水平；用药安全性；胰岛素敏感性和分泌；身体成分；营养、体力活动和身体健康；心血管危险因素；微血管并发症；生活质量；以及成本效益。研究对象为10-17岁的2型糖尿病患者，为期2年，为期3年半，随访2-6年。

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 is an NIH/NIDDK-sponsored, multicenter, randomized, controlled, clinical trial designed to evaluate the safety and efficacy of three treatment regimens for type 2 diabetes mellitus (T2DM) in children and youth. This protocol is developed by the STOPP-T2D (Studies to Treat Or Prevent Pediatric Type 2 Diabetes) study group, and will be implemented at 13 clinical centers. The three treatment regimens being compared are: metformin alone, metformin plus rosiglitazone and metformin plus an intensive lifestyle intervention aimed at 7-10% weight loss. Medication arms of the protocol are double-blinded and primary outcomes are masked with unmasking as necessary for clinical care and safety. The primary outcome is the time to "treatment failure" (defined as HbA1c8% for 6 months or an inability to avoid metabolic decompensation without insulin). Secondary outcomes include: level of glycemic control; medication safety; insulin sensitivity and secretion; body composition; nutrition, physical activity and physical fitness; cardiovascular risk factors; microvascular complications; quality of life; and cost effectiveness. Subjects 10-17 years old with T2DM for 2 years will be recruited over a 3-1/2 year period and followed for 2-6 years.