Post DPP Follow-up Study

描述(由申请人提供)： 糖尿病预防计划是一项多中心对照临床试验 检查强化生活方式干预或二甲双胍的疗效 预防或延缓糖尿病患者的发展 由于存在糖耐量受损(IGT)而导致的高风险。发展 由1997年ADA标准定义的糖尿病是主要结果，而 心血管疾病及其危险因素是重要的次要后果。 民进党从1996年年中开始招募。在本申请之时，总计 研究暴露的平均时间约为3年(2至5年)，总共 在3-ARM的3234名志愿者中，大约有10,000个病人年 学习。基于统计学上显著的和临床上令人信服的 生活方式干预中糖尿病发病的减少 二甲双胍治疗组(分别减少58%和31%)与 安慰剂治疗组、DPP数据监测委员会和NIDDK结束了 2001年5月研究的遮盖治疗阶段，比一年前 原计划的。 此应用程序旨在进一步利用科学的 和具有临床价值的民进党志愿者队列和海量数据 在研究期间收集的。高度合规的民进党队列，包括45% 少数族裔，是有史以来研究过的最大的IGT人群。此外，亚队列 已发展为糖尿病(约700人)的患者已从近 糖尿病发作的确切时间。临床上重要的研究问题 留在民进党之后。仔细收集、集中测量和 这个队列中的分级数据应该有助于明确回答以下几个问题 糖耐量低减和早发型2型糖尿病临床病程的重要问题 糖尿病。具体目标包括：1.检查长期效果和 先前民进党干预对民进党主要结果的持久性，包括 糖尿病，临床心血管疾病，动脉粥样硬化，心血管危险因素， 生活质量和成本效益；2.确定新发病的临床病程 2型糖尿病和糖耐量低减，特别是微血管和神经学方面 并发症；3.测定心血管疾病(CVD)的发生率 新发2型糖尿病和糖耐量低减患者的危险因素和动脉粥样硬化； 研究主题1-3在少数族裔人群中，男性与女性，以及老年人中 民进党的受试者。目前的申请是为期5年的资助， 尽管所述项目的一些目标将需要10年的时间 学习。

DESCRIPTION (provided by applicant): The Diabetes Prevention Program is a multicenter controlled clinical trial examining the efficacy of an intensive life-style intervention or metformin to prevent or delay the development of diabetes in a population selected to be at high risk due to the presence of impaired glucose tolerance (IGT). Development of diabetes, defined by 1997 ADA criteria, is the primary outcome while cardiovascular disease and its risk factors are important secondary outcomes. The DPP began recruitment in mid-1996. At the time of this application, total study exposure is a mean of approximately 3 years (range 2 to 5) with a total of approximately 10,000 patient years in the 3,234 volunteers in the 3-arm study. On the basis of a statistically significant and clinically compelling decrease in the development of diabetes in the life-style intervention and metformin-treated groups (58% and 31% reductions, respectively) compared with the placebo treated group, the DPP Data Monitoring Board and NIDDK ended the masked treatment phase of the study in May, 2001, one year earlier than originally planned. This application is designed to take further advantage of the scientifically and clinically valuable cohort of DPP volunteers and the large volume of data collected during the study. The highly compliant DPP cohort, including 45% minorities, is the largest IGT population ever studied. Moreover, the subcohort that has developed diabetes (n approximately 700) has been followed from near the exact time of diabetes onset. Clinically important research questions remain in the wake of the DPP. The carefully collected, centrally measured and graded data in this cohort should help to answer, definitively, a number of important questions regarding the clinical course of IGT and early onset type 2 diabetes. Specific aims include: 1. Examine the long-term effects and durability of prior DPP intervention on the major DPP outcomes including diabetes, clinical cardiovascular disease, atherosclerosis, CVD risk factors, quality of life and cost-benefit; 2. Determine the clinical course of new onset type 2 diabetes and IGT, in particular regarding microvascular and neurologic complications; 3. Determine the incidence of cardiovascular disease (CVD), CVD risk factors and atherosclerosis in new onset type 2 diabetes and IGT; and 4. Examine topics 1-3 in minority populations, men vs. women, and in older subjects in the DPP. The current application is for 5 years of funding, although the some of the goals of the projects described will require a 10-year study.