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。这是一项多中心试验，旨在评估儿童和青少年2型糖尿病（T2DM）的三种治疗方案。主要目的是比较三个治疗组在血糖控制的基础上按时治疗和治疗失败的疗效。次要目的是评估三种治疗方案的安全性和比较效果，评估个人和家庭行为对治疗反应的影响，并比较三种治疗方案的相对成本效益。三种治疗方案是：1)单用二甲双胍，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）。治疗将被掩盖，使受试者和研究小组不知道谁在服用罗格列酮。该研究招募了三年的患者，并对患者进行了至少两年（最多五年）的随访。受试者将进行血液测试、葡萄糖耐量测试，并评估营养、身体活动、身体健康、心血管危险因素、微血管并发症、生活质量和心理状态。所有受试者将接受标准的糖尿病教育。研究包括三个步骤。第一步，或“筛选步骤”，包括一次门诊就诊，了解病史、医学检查、血液和尿液测试。符合条件的受试者将进入第二步，即“跑步步骤”。第二步可能持续2-6个月（8-12次门诊就诊），包括糖尿病教育、临床检查、血糖监测、调整糖尿病药物、测试二甲双胍耐受性、测量身体活动，以及指定的家庭支持人员（FSP）的参与。第三步，或“治疗步骤”，包括随机分配到三个治疗组中的一个。所有受试者将服用2粒胶囊，每天2次，在研究的第一年每2个月进行一次医疗访问。在随后几年的研究中，每3个月进行一次访问。访问类型分为“常规”、“大型”和“超级”访问，每种访问的程序都在协议和同意书中进行了描述。受试者将被跟踪2至5年，具体取决于他们被纳入的时间。在招募参与者之前，两名试点受试者将完成一系列研究程序和评估。试验对象将是年龄大于17岁或诊断为糖尿病超过2年的儿童，否则不符合研究条件。该研究将在3年内共招募750名受试者，其中45名受试者预计在现场。大多数研究访问都需要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.