STUDIES TO TREAT OR PREVENT PEDIATRIC TYPE 2 DIABETES (STOPP-T2D): TREATMENT

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 今天试验的主要目标是在10-17岁的2型糖尿病(T2 DM)患者中，比较基于血糖控制的三种治疗方案在治疗失败前的及时疗效。次要目标是： A)比较和评价三种治疗武器的安全性； B)比较三种治疗方法对2型糖尿病患者B细胞功能和胰岛素抵抗、身体成分、营养、体力活动和有氧健身、心血管危险因素、微血管并发症、生活质量和心理结局的影响； C)评估个人和家庭行为对治疗反应的影响；以及 D)比较三种治疗武器的相对成本效益。 这三种治疗方案是：(1)单独使用二甲双胍与二甲双胍+强化生活方式干预，称为今日生活方式计划(TLP)；(2)单独使用二甲双胍与二甲双胍+罗格列酮；以及(3)二甲双胍+TLP与二甲双胍+罗格列酮。这项研究在三年内招募受试者，并对他们进行至少两年的跟踪调查。受试者在被诊断为T2 DM的两年内被随机分组。治疗失败的主要结果是根据HbA1c(在6个月内=8.0%)或无法摆脱临时胰岛素来定义的。

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. The primary objective of the TODAY trial is to compare the efficacy of the three treatment arms on time to treatment failure based on glycemic control in subjects from 10-17 years of age with type 2 diabetes mellitus (T2DM). The secondary aims are to: a) compare and evaluate the safety of the three treatment arms; b) compare the effects of the three treatments on the pathophysiology of T2DM with regards to b-cell function and insulin resistance, body composition, nutrition, physical activity, and aerobic fitness, cardiovascular risk factors, microvascular complications, quality-of-life (QoL), and psychological outcomes; c) evaluate the influence of individual and family behaviors on treatment response; and d) compare the relative cost-effectiveness of the three treatment arms. The three treatment regimens are: : (1) metformin alone versus metformin plus intensive lifestyle intervention called the TODAY Lifestyle Program (TLP), (2) metformin alone versus metformin plus rosiglitazone, and (3) metformin plus TLP versus metformin plus rosiglitazone. The study recruits subjects over a three-year period and follows them for a minimum of two years. Subjects are randomized within two years of the diagnosis of T2DM. The primary outcome of treatment failure is defined in terms of HbA1c (= 8.0% over a 6-month period) or inability to wean off temporary insulin.