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

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。这是一项NIH/ niddk赞助的多中心随机对照临床试验，旨在评估儿童和青少年2型糖尿病（T2DM）的三种治疗方案的安全性和有效性。该方案由stop - t2d（治疗或预防儿童2型糖尿病的研究）研究组制定，并将在13个临床中心实施。被比较的三种治疗方案是：单用二甲双胍、二甲双胍加罗格列酮和二甲双胍加强化生活方式干预，旨在减轻7-10%的体重。该方案的药物部分是双盲的，主要结果被掩盖，因为临床护理和安全是必要的。主要结果是“治疗失败”的时间（定义为6个月hba1c - 8%或在不使用胰岛素的情况下无法避免代谢失代偿）。次要结局包括：血糖控制水平；药物安全;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；还有成本效益。10-17岁的T2DM患者将被招募3-1/2年，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.