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，旨在检验强化生活方式干预或二甲双胍在被选为糖耐量受损(IGT)高危人群中预防或延缓糖尿病发展的有效性。由1997年ADA标准定义的糖尿病的发展是主要结果，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。在申请时，在3-ARM研究的3234名志愿者中，总研究暴露在大约3年(范围2到5)的平均时间内，总共大约10,000个病人年。生活方式干预和二甲双胍治疗组的糖尿病发病率与对照组相比分别降低了58%和31%，这在统计学上显著且临床上令人信服。 安慰剂治疗组、DPP数据监测委员会和NIDDK于2001年5月结束了这项研究的掩蔽治疗阶段，比原计划提前了一年。 这一应用程序旨在进一步利用民进党志愿者的科学和临床价值队列以及在研究期间收集的大量数据。高度顺从的民进党队列，包括45%的少数民族，是有史以来研究过的最大的IGT人群。此外，发生糖尿病的亚队列(约700人)几乎从糖尿病发病的确切时间开始进行跟踪。临床上重要的研究问题 留在民进党之后。在这个队列中仔细收集、集中测量和分级的数据应该有助于明确回答关于IGT和早发性2型糖尿病临床病程的一些重要问题。具体目标包括：1.审查先前民进党干预对主要民进党结果的长期影响和持久性，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2型糖尿病和IGT的临床病程，特别是关于微血管和神经并发症；3.确定新发2型糖尿病和IGT中心血管疾病(CVD)、心血管危险因素和动脉粥样硬化的发生率；以及4.在少数族裔人群中，男性与女性和老年人群中检查主题1-3 民进党的受试者。目前的申请是为期5年的资金，尽管所述项目的一些目标将需要10年的研究。

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.