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疗效， 预防或延迟糖尿病在选择为处于以下的人群中的发展： 由于存在葡萄糖耐量受损（IGT），风险较高。发展 根据1997年ADA标准定义的糖尿病是主要结局， 心血管疾病及其危险因素是重要的次要结局。 检察长办公室于1996年年中开始征聘。截至本申请提交之时， 研究暴露的平均时间约为3年（范围2 - 5）， 3组中3，234名志愿者的约10，000患者年 study.基于统计学显著性和临床强制性 在生活方式干预中减少糖尿病的发展， 二甲双胍治疗组（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 2001年5月，研究的设盲治疗阶段，比2002年5月提前一年。 原计划。 此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 在研究过程中收集的。高依从性DPP队列，包括45% 少数民族，是有史以来最大的IGT人群。此外，子队列 已经发展成糖尿病的人（n约700）， 糖尿病发病的确切时间临床重要研究问题 在民进党之后。仔细收集，集中测量， 这个队列中的分级数据应该有助于明确回答一些问题， 关于IGT和早发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， DPP先前干预对DPP主要成果的持久性，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.确定新发病例的临床病程 2型糖尿病和IGT，特别是关于微血管和神经系统 并发症; 3.确定心血管疾病（CVD）的发病率，CVD 新发2型糖尿病和IGT的危险因素和动脉粥样硬化;和4. 在少数群体、男性与女性以及老年人中研究主题1-3 DPP中的主题。目前的申请是5年的资助， 尽管所描述的项目的一些目标将需要10年的时间， study.