Diabetes Prevention Program Outcome Study - Phase 2

描述（由申请人提供）：糖尿病预防计划（DPP）是一项在多种族糖耐量受损超重人群中进行的多中心对照临床试验，确定了旨在适度减轻体重和增加中等强度活动的生活方式干预以及二甲双胍分别将糖尿病发展降低58%和31%的疗效。DPP结局研究（DPPOS）是一项为期10年的随访研究，于2002年1月1日获得了为期5年的资助，但前提是该研究需要通过竞争性续期进行退款。DPPOS的总体目标是研究DPP中显示的延迟糖尿病的相对短期益处是否会转化为更持久的影响，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风险因素的影响; 2）检查既往DPP干预对糖尿病进一步发展的长期影响和持久性; 3）描述新发2型糖尿病和IGT患者远期并发症的发生率及其危险因素。DPPOS包括维持原DPP二甲双胍组二甲双胍治疗，并继续对原生活方式组进行生活方式干预。迄今为止，在DPP/DPPOS治疗10年后，93%的DPPOS队列参加了年度随访。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的持久效果已被证明分别降低了36%和19%的糖尿病发病率。中期分析还显示，干预组的心血管疾病风险因素显著降低，药物利用率降低。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，重点是需要更多时间开发的复杂性。 相关性：糖尿病预防计划（DPP）和DPP结局研究（DPPOS）的前5年已经证明，旨在减肥的生活方式干预计划和二甲双胍可在10年内预防糖尿病发展。DPPOS的完成将检查糖尿病预防对影响眼睛、肾脏、神经和心脏的长期并发症的影响，这对公共卫生仍然至关重要。

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.