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。 在过去的十年里，儿童2型糖尿病的发病率急剧上升。起病越早，病程越长，这些儿童的医疗费用就越高；他们的并发症也可能比中年确诊的患者更多。对于儿童2型糖尿病维持正常血糖和预防并发症的最佳治疗方法，发表的经验很少。这项试验将确定3种治疗方法中哪一种在维持血糖控制方面最有效。虽然试验的时间不足以评估这三组患者的并发症是否有显著差异，但将测量与并发症相关的替代标记物(例如，血脂、C反应蛋白、微量蛋白尿)。 这是一项前瞻性、部分双盲、随机的临床试验，有3个治疗分支：单独使用二甲双胍，二甲双胍加强化生活方式治疗(行为矫正计划)。主要终点是连续6个月或6个月以上的失败时间，定义为血红蛋白A1c；或=8%。在2-6个月的跑步期间，受试者每隔1-4周就会出现一次。在随机抽样后，第一年每2个月看一次受试者，随后几年每3个月看一次。此外，生活方式组的受试者将在前6个月每周见一次PAL(体力活动和营养主管)，在后6个月每2周见一次，此后每月见一次。终点测量将在随机、6个月、24个月和研究结束时进行。 今天试验的主要目标是比较基于血糖控制的三种治疗方案的及时疗效和治疗失败情况。次要目标是：比较和评估三种治疗方法的安全性；比较三种治疗方法在β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、生活质量和心理结果等方面对T2 DM病理生理学的影响；评估个人和家庭行为对治疗反应的影响；以及比较三种治疗方法的相对成本效益。

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 incidence of type 2 diabetes in children has increased dramatically in the past decade. With earlier onset and thus longer duration of disease these children will have increased health care costs; they may also have more complications than someone diagnosed in middle age. There is little published experience on the best treatment to maintain normal glycemia and prevent complications in children with type 2 diabetes. This trial will determine which of 3 treatments is most effective in maintaining glycemic control. Although the trial will not be long enough to assess if there is a significant difference in complications between these 3 arms, surrogate markers associated with complications will be measured (e.g., lipid profile, C-reactive protein, microalbuminuria). This is a prospective, partially double-blinded, randomized clinical trial with 3 treatment arms: metformin alone, metformin plus intensive lifestyle treatment (behavior modification program). The primary endpoint is time to failure defined as hemoglobin A1c> or =8% for 6 or more consecutive months. Subjects will be seen every 1 to 4 weeks during the 2-6 months of the runnin. After randomization, subjects will be seen every 2 months in the first year and every 3 months in subsequent years. In addition, subjects in the lifestyle arm will meet with a PAL (physical activity and nutrition leader) once a week for the first 6 months, every 2 weeks in the 2nd 6 months and monthly thereafter. Endpoint measurements will be done at randomization, 6 months, 24 months and end of study. 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. The secondary aims are to: compare and evaluate the safety of the three treatment arms; compare the effects of the three treatments on the pathophysiology of T2DM with regards to beta cell function and insulin resistance, body composition, nutrition, physical activity and aerobic fitness, cardiovascular risk factors, microvascular complications, quality of life, and psychological outcomes; evaluate the influence of individual and family behaviors on treatment response; and compare the relative cost effectiveness of the three treatment arms.