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

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这是一项多中心试验，旨在评估儿童和青少年2型糖尿病（T2 DM）的三种治疗方案。主要目的是比较三个治疗组基于血糖控制的至治疗失败时间的疗效。次要目的是评价三种治疗方案的安全性和比较效果，评价个人和家庭行为对治疗反应的影响，比较三种治疗方案的相对成本效果。三种治疗方案是：1）二甲双胍单药，2）二甲双胍加罗格列酮，3）二甲双胍加强化生活方式干预，称为今日生活方式计划（TLP）。治疗将设盲，因此受试者和研究团队不知道谁正在服用罗格列酮。该研究招募了三年的患者，并对患者进行了至少两年（最长五年）的随访。受试者将接受血液检查、葡萄糖耐量试验以及营养、体力活动、身体健康、心血管风险因素、微血管并发症、生活质量和心理状态评估。所有受试者将接受标准糖尿病教育。该研究包括三个步骤。第1步，或称“筛查步骤”，包括一次门诊访视，以了解病史、医学检查以及血液和尿液检查。合格受试者将继续进行步骤2或“导入步骤”。第二步可能持续2-6个月（8-12次门诊），包括糖尿病教育、临床检查、血糖监测、调整糖尿病药物、二甲双胍耐受性测试、测量体力活动以及指定家庭支持人员（FSP）的参与。步骤3，或“治疗步骤”，涉及随机分配至三个治疗组之一。在研究的第一年，所有受试者将每天服用2粒胶囊，每天2次，每2个月进行一次医学访视。在研究的随后几年中，每3个月进行一次访视。访视类型分为“常规”、“大型”和“超级”访视，方案和知情同意书中描述了每种访视的程序。受试者将接受2 - 5年的随访，具体取决于其入组时间。在入组受试者之前，两名试点受试者将完成一系列研究程序和评估。初步受试者将是因年龄超过17岁或诊断为糖尿病超过2年而不符合研究资格的儿童。本研究将在3年内入组共计750例受试者，预计该研究中心将入组45例受试者。大多数研究访视都需要GCRC。

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. This is a multi-center trial designed to evaluate three treatment regimens for type 2 diabetes (T2DM) in children and youth. The primary objective is to compare the efficacy of the three treatment arms on time to treatment failure based on glycemic control. The secondary aims are to evaluate the safety and compare the effects of the three treatment regimens, to evaluate the influence of individual and family behaviors on treatment response, and to compare the relative cost effectiveness of the three treatment plans. The three treatment regimens are: 1) metformin alone, 2) metformin plus rosiglitazone, and 3) metformin plus an intensive lifestyle intervention called the TODAY Lifestyle Program (TLP). Treatment will be masked so that subjects and study team do not know who is taking rosiglitazone. The study recruits patients over a three-year period and follows patients for a minimum of two years (maximum of five years). Subjects will have blood tests, glucose tolerance tests, and assessments of nutrition, physical activity, physical fitness, cardiovascular risk factors, microvascular complications, quality of life and psychological status. All subjects will receive standard diabetes education. The study consists of three steps. Step 1, or the "screening step", consists of one outpatient visit for history, medical examination, and blood and urine tests. Eligible subjects will proceed to Step 2, or the "run in step." Step 2 may last 2-6 months (8-12 outpatient visits) and consists of diabetes education, clinical examinations, blood sugar monitoring, adjusting diabetes medications, testing tolerance of metformin, measuring physical activity, and the involvement of the designated Family Support Person (FSP). Step 3, or the "treatment step", involves randomization into one of the three treatment arms. All subjects will take 2 capsules 2 times a day and have a medical visit once every 2 months for the first year of the study. In subsequent years of the study, the visits are every 3 months. Visit types are classified as "regular", "big", and "super" visits and the procedures for each are described in the protocol and consent form. Subjects will be followed for 2 to 5 years depending on when they were enrolled. Prior to enrollment of participants, two pilot subjects will complete a series of study procedures and assessments. The pilot subjects will be children who are not otherwise eligible for the study because they are greater than 17 years or have had a diagnosis of diabetes for greater than 2 years. The study will enroll a total of 750 subjects over 3 years with 45 subjects expected at this site. The GCRC is needed for the majority of the study visits.