Coordinating Center for Look AHEAD: Health in Diabetes

(修订摘要) 超重和肥胖是美国的主要健康问题，影响着超过50%的成年人。超重或肥胖的长期后果包括增加死亡率和各种相关疾病状态的发病率增加。短期减肥已被证明可以改善肥胖相关的代谢异常和心血管疾病危险因素。然而，观察性研究提出了对减肥和体重循环的长期负面影响的担忧，包括增加死亡率。 Look Advance(糖尿病健康行动)是一项双臂随机对照临床试验，研究16个临床中心的超重和肥胖的2型糖尿病志愿者。将招募大约5000名患有2型糖尿病的志愿者，年龄在45-75岁之间，体重指数为25公斤/米，其中男性和女性人数大致相同，至少33%的参与者来自少数民族群体。 展望未来的主要目标是检查密集生活方式干预的长期健康影响，旨在通过减少卡路里摄入量和增加体力活动来实现和保持减肥。生活方式干预是在个人监督和小组会议的情况下实施的，旨在实现体重比基线至少减少7%，平均每周体力活动175分钟，并保持这些目标。这项计划将与涉及糖尿病支持和教育计划的控制条件进行比较。 基本假设是，在长达11.5年的计划随机化后，在被分配到生活方式干预的参与者中，与被分配到糖尿病支持和教育组的参与者相比，被分配到生活方式干预的参与者中，包括心血管死亡(包括致命性心肌梗死和中风)、非致命性心肌梗死和非致命性中风的综合结果的首次随机化发生的发生率将降低。这项研究预计有90%的概率在两组之间检测到18%的主要结果差异。已经确定了所有死亡、心血管事件和心血管疾病手术的综合次要结果。其他结果包括：糖尿病控制和并发症、健身、一般健康、与健康相关的生活质量和心理结果。将评估生活方式干预相对于糖尿病支持和教育的成本和成本效益。

(Revised Abstract) Overweight and obesity are major health problems in the United States, affecting more than 50% of adults. The long-term consequences of being overweight or obese include increased mortality and increased morbidity from a variety of associated disease states. Short-term weight loss has been demonstrated to ameliorate obesity-related metabolic abnormalities and cardiovascular disease risk factors. However, observational studies have raised concerns about negative effects of weight loss and weight cycling over the long term, including increased mortality. Look AHEAD (Action For Health in Diabetes) is a 2-armed randomized controlled clinical trial studying overweight and obese volunteers with type 2 diabetes at 16 clinical centers. Approximately 5,000 volunteers with type 2 diabetes aged 45-75 years with body mass index > 25 kg/m will be recruited, including approximately equal numbers of men and women and at least 33% participants from ethnic minority groups. The primary objective of Look AHEAD is to examine the long-term health effects of an intensive Lifestyle Intervention designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity. The Lifestyle intervention is implemented with individual supervision and group sessions and aims to achieve at least a 7% decrease in weight from baseline and 175 minutes per week in physical activity on average and to sustain these goals. This program will be compared to a control condition involving a program of Diabetes Support and Education. The primary hypothesis is that the incidence rate of the first post-randomization occurrence of a composite outcome, which includes cardiovascular death (including fatal myocardial infarction and stroke), non-fatal myocardial infarction, and non-fatal stroke, over a planned follow-up period of up to 11.5 years will be reduced among participants assigned to the Lifestyle Intervention compared to those assigned to Diabetes Support and Education. The study is projected to have 90% probability of detecting an 18% difference in this primary outcome between the 2 groups. A composite secondary outcome of all deaths, CVD events, and CVD procedures has been defined. Additional outcomes include: diabetes control and complications, fitness, general health, health-related quality of life, and psychological outcomes. The cost and cost effectiveness of the Lifestyle Intervention relative to Diabetes Support and Education will be assessed.