DDP LONG-TERM FOLLOW-UP STUDY

DDP长期跟踪研究

• 批准号: 8230662
• 负责人: Ronald B Goldberg
• 金额: $ 53.94万
• 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 2015-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8230662
• 关键词: Affect; Ankle; Atherosclerosis; Body Weight decreased; Cardiovascular Diseases; Clinical; Controlled Clinical Trials; Development; Diabetes Mellitus; Diabetes prevention; Diabetic Angiopathies; Epidemic; Epidemiology; Event; Eye; Frequencies; Funding; Genetic; Genotype; Goals; Health Care Costs; Heart; Incidence; Intention; Intervention; Kidney; Kidney Diseases; Life Style; Long-Term Effects; Measures; Mediating; Metformin; Microalbuminuria; Nerve; Neurologic; Neuropathy; Non-Insulin-Dependent Diabetes Mellitus; Outcome; Outcome Study; Overweight; Persons; Pharmaceutical Preparations; Phenotype; Placebos; Population; Prediabetes syndrome; Principal Investigator; Public Health; Quality of life; Retinal Diseases; Risk Factors; Time; Translating; Visit; Weight Gain; base; cardiovascular disorder risk; cognitive change; cohort; coronary artery calcification; design; diabetes prevention program; diabetic patient; follow-up; group intervention; impaired glucose tolerance; indexing; 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 attend 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) 是一项针对糖耐量受损的超重人群的多种族人群的多中心对照临床试验，确定了针对适度体重的生活方式干预的有效性减少和增加中等强度的活动，以及二甲双胍的使用分别可将糖尿病的发生率降低 58% 和 31%。 DPP 结果研究 (DPPOS) 是一项为期 10 年的后续研究，由 1^2002 资助，为期五年，但需要通过竞争性更新进行退款。 DPPOS 的首要目标是研究 DPP 所展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。具体来说，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 干预措施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 的长期并发症的发生率及其危险因素。 DPPOS 包括努力维持原来的 DPP 二甲双胍组服用二甲双胍，并继续对原来的生活方式组进行生活方式干预。迄今为止，在 DPP/DPPOS 实施 10 年后，93% 的 DPPOS 群体参加了年度随访。与安慰剂组相比，与生活方式和二甲双胍干预措施相关的糖尿病预防的持久效果已被证明，糖尿病发病率分别降低了 36% 和 19%。中期分析还显示，干预组的 CVD 危险因素显着减少，药物使用量减少。糖尿病的发生与视网膜病变和微量白蛋白尿的发生率增加有关。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。 相关性：糖尿病预防计划 (DPP) 和 DPP 结果研究 (DPPOS) 的前 5 年已证明，旨在减肥的生活方式干预计划和二甲双胍可在 10 年内预防糖尿病的发生。 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，并且对公众健康仍然至关重要。