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

这个子项目是许多利用 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。 TODAY试验的主要目的是在10-17岁的2型糖尿病（T2 DM）受试者中，基于血糖控制，比较三个治疗组在至治疗失败时间方面的疗效。 次要目标是： a）比较和评估三个治疗组的安全性; B）比较三种治疗对T2 DM病理生理学的影响，包括b细胞功能和胰岛素抵抗、身体组成、营养、体力活动和有氧健身、心血管风险因素、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;以及 d）比较三个治疗组的相对成本效益。 三种治疗方案是：（1）二甲双胍单药与二甲双胍加强化生活方式干预（称为TODAY Lifestyle Program（TLP）），（2）二甲双胍单药与二甲双胍加罗格列酮，（3）二甲双胍加TLP与二甲双胍加罗格列酮。 这项研究招募了为期三年的受试者，并对他们进行了至少两年的随访。 受试者在诊断为T2 DM的两年内随机分组。 治疗失败的主要结局定义为HbA 1c（6个月内≥ 8.0%）或无法停用临时胰岛素。

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.