Post DPP Follow-up Study

DPP 后后续研究

• 批准号: 7023262
• 负责人: Ronald B Goldberg
• 金额: $ 41.46万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-08-20 至 2009-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7023262
• 关键词: African American; atherosclerosis; clinical research; clinical trials; cooperative study; diabetes mellitus therapy; diabetic cardiomyopathy; diet therapy; disease /disorder prevention /control; disease /disorder proneness /risk; exercise; gender difference; gestational diabetes mellitus; glucose tolerance; glucose tolerance test; human subject; human therapy evaluation; longitudinal human study; metformin; racial /ethnic difference

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.

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功效 在选定的人群中预防或延缓糖尿病的发展 由于存在糖耐量受损 (IGT)，因此存在高风险。发展 1997 年 ADA 标准定义的糖尿病的发生是主要结局，而 心血管疾病及其危险因素是重要的次要结局。 民进党于1996年中开始招募。在提出本申请时，总计 研究暴露时间平均约为 3 年（范围 2 至 5），总计 三臂组的 3,234 名志愿者中约有 10,000 个患者年 学习。基于统计学上显着且具有临床说服力的 生活方式干预可减少糖尿病的发生， 与二甲双胍治疗组相比（分别减少 58% 和 31%） 安慰剂治疗组、DPP 数据监测委员会和 NIDDK 结束了 该研究的隐蔽治疗阶段于 2001 年 5 月进行，比 原本计划的。 该应用程序旨在进一步利用科学 具有临床价值的 DPP 志愿者队列和大量数据 研究期间收集的。高度顺从的民进党群体，包括 45% 少数民族，是有史以来研究的最大的 IGT 人群。此外，子队列 患有糖尿病的人（大约 700 人）已被跟踪近 糖尿病发病的确切时间。临床重要的研究问题 继续追随民进党。精心收集、集中测量和 该队列中的分级数据应该有助于明确地回答一些问题 关于 IGT 和早发型 2 型临床病程的重要问题 糖尿病。具体目标包括： 1. 检查长期影响和 先前 DPP 干预对主要 DPP 结果的持久性，包括 糖尿病、临床心血管疾病、动脉粥样硬化、CVD危险因素、 生活质量和成本效益； 2. 确定新发临床病程 2 型糖尿病和 IGT，特别是微血管和神经系统方面 并发症； 3.确定心血管疾病（CVD）的发生率、CVD 新发 2 型糖尿病和 IGT 的危险因素和动脉粥样硬化；和 4. 检查少数民族人口、男性与女性以及老年人中的主题 1-​​3 民进党的主题。目前的申请为期5年， 尽管所描述的项目的一些目标需要 10 年的时间 学习。