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

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。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 研究中心，而研究中心不一定是研究者所在的机构。 这是一项由NIH/NIDDK申办的多中心、随机、对照临床试验，旨在评价儿童和青少年2型糖尿病（T2 DM）三种治疗方案的安全性和疗效。 该方案由STOPP-T2 D（治疗或预防儿童2型糖尿病的研究）研究小组制定，并将在13个临床中心实施。 比较的三种治疗方案是：二甲双胍单药、二甲双胍加罗格列酮和二甲双胍加强化生活方式干预，目的是减轻7-10%体重。 该方案的药物组是双盲的，主要结局是盲态的，根据临床护理和安全性的需要进行揭盲。 主要结局是至“治疗失败”的时间（定义为HbA 1c>8%持续6个月或在没有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;用药安全;胰岛素敏感性和分泌;身体成分;营养、体育活动和身体健康;心血管风险因素;微血管并发症;生活质量;以及成本效益。 将在2-1/2年的时间内招募10-17岁的T2 DM <2年的受试者，并随访2-5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 HbA1c>8% 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 2-1/2 year period and followed for 2-5 years.