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

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。在过去十年中，儿童2型糖尿病的发病率急剧上升。这些儿童发病较早，因而病程较长，将增加保健费用；他们也可能比中年确诊的人有更多的并发症。关于维持2型糖尿病儿童正常血糖和预防并发症的最佳治疗方法，目前发表的经验很少。该试验将确定三种治疗方法中哪一种在维持血糖控制方面最有效。虽然试验时间不够长，不足以评估这三个组之间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志物（例如，脂质谱、c反应蛋白、微量白蛋白尿）。这是一项前瞻性、部分双盲、随机临床试验，有3个治疗组：单用二甲双胍、二甲双胍加罗格列酮、二甲双胍加强化生活方式治疗（行为改变项目）。主要终点是失效时间，定义为连续6个月或更长时间血红蛋白A1c >或= 8%。在2-6个月的跑步过程中，受试者将每1 - 4周见一次面。随机化后，第一年每2个月观察一次受试者，随后每3个月观察一次。此外，生活方式组的受试者将在前6个月每周见一次PAL（身体活动和营养主管），在后6个月每两周见一次，之后每月见一次。终点测量将在随机化、6个月、24个月和研究结束时进行。

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 rosiglitazone, and metformin plus intensive lifestyle treatment (behavior modification program). The primary endpoint is time to failure defined as a 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.