Diabetes Prevention Program Outcomes Study - Phase 2

描述（由申请人提供）：糖尿病预防项目（DPP）是一项在多种族超重且糖耐量受损的人群中进行的多中心对照临床试验，确定了以适度减肥和增加中等强度活动为目标的生活方式干预的有效性，以及二甲双胍分别将糖尿病的发病率降低58%和31%。民进党成果研究（DPPOS）是一项为期10年的后续研究，于2002年获得资助，为期5年，并了解需要通过竞争性续期退还资金。DPPOS的总体目标是研究DPP中显示的延迟糖尿病的相对短期效益是否会转化为更长期的影响，从而减轻糖尿病流行的公共卫生负担。具体而言，DPPOS有以下主要目标：1)确定DPP干预对长期微血管和心血管疾病（CVD）并发症、动脉粥样硬化和CVD危险因素的影响；2)检查先前DPP干预对糖尿病进一步发展的长期影响和持久性；3)了解新发2型糖尿病和IGT患者的长期并发症发生率及其危险因素。DPPOS包括维持原DPP二甲双胍组使用二甲双胍的努力，并继续对原生活方式组进行生活方式干预。迄今为止，经过10年的DPP/DPPOS， 93%的DPPOS队列参加年度随访。与安慰剂组相比，与生活方式和二甲双胍干预相关的糖尿病预防具有持久的效果，糖尿病发病率分别降低了36%和19%。中期分析还显示，干预组心血管疾病危险因素显著降低，药物使用率降低。糖尿病的发展与视网膜病变和微量白蛋白尿的频率增加有关。该应用程序旨在支持完成DPPOS的第二个五年，重点关注需要更多时间开发的并发症。

DESCRIPTION (provided by applicant): The Diabetes Prevention Program (DPP), a multi-center controlled clinical trial in a multiracial population of overweight persons with impaired glucose tolerance, established the efficacy of a life-style intervention aimed at a modest degree of weight loss and increased moderate-intensity activity, and of metformin in decreasing the development of diabetes by 58 and 31%, respectively. The DPP Outcome Study (DPPOS), a 10-year follow-up, was funded 1^2002 for a five-year period with the understanding that it would require refunding via competitive renewal. The overarching goal of DPPOS was to study whether the relatively shortterm benefits of delaying diabetes demonstrated in the DPP would translate into a more long-lasting impact that would reduce the public health burden of the diabetes epidemic. Specifically, DPPOS had the following major goals: 1) to determine the effects of DPP interventions on the long-term microvascular and cardiovascular disease (CVD) complications, atherosclerosis and CVD risk factors; 2) to examine the long-term effects and durability of prior DPP interventions on further diabetes development; and 3) to describe the incidence of long-term complications and their risk factors in new onset type 2 diabetes and IGT. The DPPOS included an effort to maintain the original DPP metformin group on metformin and to continue a lifestyle intervention for the original lifestyle group. To date, after 10 years of DPP/DPPOS, 93% of the DPPOS cohort attends annual follow-up visits. A durable effect of diabetes prevention associated with the lifestyle and metformin interventions has been demonstrated with 36 and 19% reductions in diabetes incidence, respectively, compared with the placebo group. Interim analyses also reveal significant reductions in CVD risk factors in the intervention groups, with decreased utilization of medications. The development of diabetes is associated with an increased frequency of retinopathy and microalbuminuria. This application is designed to support completing the second five years of DPPOS focusing on complications that require more time to develop. RELEVANCE: The Diabetes Prevention Program (DPP) and first 5 years of the DPP Outcome Study (DPPOS) have demonstrated that a lifestyle intervention program aimed at weight loss, and metformin, prevent diabetes development over a 10 year period. Completion of DPPOS will examine the impact of diabetes prevention on long-term complications affecting the eye, kidney, nerves and heart, and remains critical to public health.