Diabetes Prevention Program Outcomes Study - Phase 2

糖尿病预防计划成果研究 - 第 2 阶段

• 批准号: 8607932
• 负责人: Vanita Aroda
• 金额: $ 53.4万
• 依托单位: MEDSTAR HEALTH RESEARCH INSTITUTE
• 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 2015-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8607932
• 关键词: Affect; Atherosclerosis; Body Weight decreased; Cardiovascular Diseases; Clinical; Controlled Clinical Trials; Development; Diabetes Mellitus; Diabetes prevention; Epidemic; Eye; Frequencies; Funding; Genotype; Goals; Heart; Incidence; Intervention; Kidney; Life Style; Long-Term Effects; Metformin; Microalbuminuria; Microvascular Dysfunction; Nerve; Non-Insulin-Dependent Diabetes Mellitus; Outcome Study; Overweight; Persons; Pharmaceutical Preparations; Phase; Phenotype; Placebos; Population; Prediabetes syndrome; Public Health; Retinal Diseases; Risk Factors; Time; Translating; Visit; Weight Gain; cardiovascular disorder risk; cohort; design; diabetes prevention program; diabetic patient; follow-up; group intervention; impaired glucose tolerance; intervention program; lifestyle intervention; prevent

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.

描述(由申请人提供)：糖尿病预防计划(DPP)是一项多中心控制的临床试验，在多种族超重和糖耐量受损的人群中进行，确定了旨在适度减肥和增加中等强度活动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生减少58%和31%。民进党成果研究(DPPOS)是一项为期10年的后续行动，2002年1月1日获得资助，为期5年，但有一项谅解，即它将需要通过竞争续期退款。DPPOS的总体目标是研究DPP中显示的延迟糖尿病的相对短期好处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。具体地说，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效果和持久性；以及3)描述新发2型糖尿病和IGT的长期并发症发生率及其危险因素。DPPOS包括一项努力，以维持原来的DPP二甲双胍治疗组，并继续对原来的生活方式组进行生活方式干预。到目前为止，经过10年的行动计划/行动计划，93%的行动计划工作人员每年都会参加后续访问。与安慰剂组相比，生活方式和二甲双胍干预预防糖尿病具有持久的效果，糖尿病发病率分别降低了36%和19%。中期分析还显示，随着药物使用的减少，干预组的心血管疾病危险因素显著减少。糖尿病的发展与视网膜病变和微量白蛋白尿的增加有关。此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。 相关性：糖尿病预防计划(DPP)和DPP结果研究的前5年(DPPOS)已经证明，旨在减肥和二甲双胍的生活方式干预计划可以在10年内预防糖尿病的发展。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，并且仍然对公众健康至关重要。