DDP LONG-TERM FOLLOW-UP STUDY

DDP长期跟踪研究

• 批准号: 7792234
• 负责人: Ronald B Goldberg
• 金额: $ 45.9万
• 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 2014-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7792234
• 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; Follow-Up Studies; Frequencies; Funding; Genetic; Genotype; Goals; Health Care Costs; Heart; Incidence; 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; 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），这是一项多中心对照临床试验，对葡萄糖耐受性受损的超重人群中的多种族人群，确立了生命式干预的疗效，该干预措施的疗效是针对体重损失和增加的31％降低的31％和31％的发展，并降低了31％的发展。 DPP成果研究（DPPO）是一项为期10年的随访，在2002年1月1日获得了五年的资金，并了解这将需要通过竞争性续签退还。 DPPO的总体目标是研究延迟DPP中证明的糖尿病的相对短期益处是否会转化为更持久的影响，这将减轻糖尿病流行的公共卫生负担。具体而言，DPPO具有以下主要目标：1）确定DPP干预措施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干预措施对进一步糖尿病发育的长期影响和耐用性； 3）描述新发作2型糖尿病和IGT中长期并发症及其危险因素的发生率。 DPPO包括努力维持原始的DPP二甲双胍组，并继续为原始生活方式组进行生活方式干预。迄今为止，经过10年的DPP/DPPO，DPPO人群中有93％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持续效果分别降低了36％和19％。临时分析还显示，干预组中CVD危险因素的大幅降低，药物利用降低。糖尿病的发育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第二五年的DPPO，重点关注需要更多时间开发的并发症。 相关性：预防糖尿病计划（DPP）和DPP成果研究的前5年（DPPO）表明，旨在减肥的生活方式干预计划和二甲双胍，可以在10年内预防糖尿病的发展。 DPPO的完成将检查预防糖尿病对影响眼睛，肾脏，神经和心脏的长期并发症的影响，并且对公共卫生仍然至关重要。