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

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。TODAY试验的主要目的是比较三个治疗组在10-17岁2型糖尿病（T2DM）患者中基于血糖控制的按时治疗和治疗失败的疗效。次要目的是：a)比较和评价三个治疗组的安全性；b)比较三种治疗方法对T2DM病理生理的影响，包括b细胞功能和胰岛素抵抗、身体组成、营养、体力活动和有氧适能、心血管危险因素、微血管并发症、生活质量（QoL）和心理结局；C)评估个人和家庭行为对治疗反应的影响；d)比较三个治疗组的相对成本效益。这三种治疗方案是：(1)单用二甲双胍vs二甲双胍加强化生活方式干预，即今天生活方式计划（TLP）；(2)单用二甲双胍vs二甲双胍加罗格列酮；(3)单用二甲双胍加TLP vs二甲双胍加罗格列酮。这项研究招募了为期三年的研究对象，并对他们进行了至少两年的跟踪调查。受试者在诊断为T2DM后两年内随机选取。治疗失败的主要结局是根据HbA1c（6个月期间= 8.0%）或无法戒除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.