Look AHEAD: Action for Health in Diabetes

描述(由申请人提供)：展望未来是一项随机临床试验，研究对大约5145名患有2型糖尿病的超重志愿者进行强化减肥干预对健康的长期影响。参与者被随机分为两组，一组是密集的生活方式干预，旨在通过减少卡路里摄入量和增加体力活动来实现并保持体重减轻，另一组是糖尿病支持和教育控制计划。展望未来的主要结果是在计划的11.5年的随访中，严重心血管事件(致命和非致命的ML以及中风和心血管死亡)的总发生率。最初的赠款申请为研究的头7年提供了资金(1年用于研究设计，6年用于试验执行)。目前的赠款申请是为了再提供7年的资金，以完成展望试验。研究的所有方面都进行得非常顺利--5145名样本是按时招募的；保留率一直很高，干预措施在最初的体重减轻和随着时间的推移保持体重方面一直很有效。所有16个临床站点都在招募、保留和交付干预措施方面取得了成功，dsmb对试验的执行非常积极。本申请回顾了展望未来的总体设计、迄今的进展和未来的计划。具体目标是随着时间的推移保留队列，继续完成每年一次的面对面访问和每半年一次的电话访谈，以进行结果评估，并继续实施生活方式干预。这些程序将使我们能够分析干预对严重心血管相关因素和并发症的影响，以及干预的成本效益。

DESCRIPTION (provided by applicant): Look AHEAD is randomized clinical trial examining the long-term health effects of an intensive weight loss intervention in approximately 5,145 overweight volunteers with type 2 diabetes. Participants are randomized to an intensive lifestyle intervention designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity, or to a control program of diabetes support and education. The primary outcome of Look AHEAD is the aggregate occurrence of severe cardiovascular events (fatal and non-fatal Ml and stroke and cardiovascular deaths) over a planed follow-up of 11.5 years. The original grant application provided funding for the first 7 years of the study (1 year for study design and 6 for execution of the trial). The present grant application is for an additional 7 years of funding to complete the Look AHEAD trial. All aspects of the study have proceeded extremely well - the sample of 5,145 was recruited on time; retention has been excellent and the intervention has been effective in producing initial weight loss and maintaining it over time. All 16 clinical sites have been successful in recruitment, retention, and delivery of the intervention and the DSMB has been very positive about the execution of the trial. The present application reviews the overall design of Look AHEAD, progress to date, and plans for the future. Specific Aims are to retain the cohort over time, continue to complete annual in-person visits and semi-annual telephone interviews for outcome assessments and continue to administer the lifestyle intervention. These procedures will enable us to analyze the effects of the intervention on serious cardiovascular- related factors and complications, and cost-effectiveness of the intervention.