CLINICAL TRIAL: LOOK AHEAD: ACTION FOR HEALTH IN DIABETES

这个子项目是许多利用资源的研究子项目之一 由NIH/NCRR资助的中心拨款提供。次级项目的主要支助 子项目的主要研究者可能是由其他来源提供的， 包括其它NIH来源。 列出的子项目总成本可能 表示子项目使用的中心基础设施的估计数量， 而不是由NCRR赠款提供给子项目或子项目工作人员的直接资金。 展望未来，多中心，随机对照临床试验将检查旨在减肥的生活方式干预计划对几种健康结果的影响。主要研究目的是确定参与生活方式干预是否能有效降低超重2型糖尿病成人严重心血管疾病事件的发生率。其他重要的研究目标是评估减肥和健身变化对一系列疾病过程和结果的影响，并评估减肥干预的成本效益。 研究队列将包括5，000名超重（体重指数至少为25 kg/m2）的2型糖尿病患者（通过自我报告进行验证或治疗）。美国16个中心将分别招募约313人参加试验。将招募有或无心血管疾病既往史的个体。 参与者将根据中心进行分层，并随机分配到生活方式干预或控制干预，糖尿病支持和教育。生活方式干预旨在通过生活方式计划（如有指征，随后使用减肥药物）产生并维持体重减轻和健身增加。这种干预包括为期6个月的每周会议的个人和小组会议，然后在试验的剩余时间内减少联系频率。 糖尿病支持和教育小组将接受营养和体育活动教育和社会支持。两组受试者将接受与糖尿病管理相关问题的可比教育。 Look AHEAD的参与者将从独立于Look AHEAD工作人员的医疗保健提供者那里获得一般医疗护理。 将每年对参与者进行随访，直至2012年，最长随访时间为11.5年。结果指标包括可能受到体重减轻积极影响的指标（例如心血管事件）和可能受到负面影响的指标（例如骨矿物质密度）。该研究还将评估体重减轻可能影响心血管事件和死亡率的一些潜在机制（例如，通过改善对心血管风险因素的控制）。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. The Look AHEAD, multicenter, randomized controlled clinical trial will examine the impact on several health outcomes of a lifestyle intervention program designed to produce weight loss. The primary study objective is to determine whether participation in a lifestyle intervention is effective in reducing the incidence of serious cardiovascular disease events in overweight adults with type 2 diabetes. Other important study objectives are to assess the impact of weight loss and fitness changes on a range of disease processes and outcomes and to evaluate the cost-effectiveness of the weight loss intervention. The study cohort will include 5,000 overweight (body mass index of at least 25 kg/m2) individuals with type 2 diabetes (as established by self-report with verification or treatment). Sixteen centers across the United States will each recruit approximately 313 persons into the trial. Individuals with or without a prior history of cardiovascular disease will be recruited. Participants will be stratified according to center, and randomly assigned to either Lifestyle Intervention or a control intervention, Diabetes Support and Education. The Lifestyle Intervention is designed to produce and maintain weight loss and increased fitness through a lifestyle program augmented, if indicated, by subsequent use of weight loss medication. This intervention includes individual and group sessions with weekly meetings for six months followed by decreasing frequency of contact over the remainder of the trial. The Diabetes Support and Education group will receive sessions of nutrition and physical activity education and social support. Participants in both arms will receive comparable education in issues related to diabetes management. Participants in Look AHEAD will receive their general medical care from a health care provider who is separate from the Look AHEAD staff. Participants will be followed annually until 2012, resulting in a maximum of 11.5 years of participant follow-up. Outcome measures include those that might be positively affected by weight loss (e.g. cardiovascular events) and those that might be negatively affected (e.g. bone mineral density). The study will also assess some of the potential mechanisms by which weight loss may influence cardiovascular events and mortality (e.g. through improved control of cardiovascular risk factors).