Look AHEAD (Action for Health in Diabetes): design and methods for a clinical trial of weight loss for the prevention of cardiovascular disease in type 2 diabetes
Look AHEAD (Action for Health in Diabetes): design and methods for a clinical trial of weight loss for the prevention of cardiovascular disease in type 2 diabetes
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DOI：
10.1016/s0197-2456(03)00064-3
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发表时间：
2003-10-01
期刊：
影响因子：
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通讯作者：
Yanovski, SZ
中科院分区：
文献类型：
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作者：
Brancati, F;Charleston, J;Yanovski, SZ
超重和肥胖是2型糖尿病和心血管疾病（CVD）的主要原因。此外，超重或肥胖的2型糖尿病患者CVD发病率和死亡率的风险特别高。虽然短期减肥已被证明可以改善肥胖相关的代谢异常和CVD风险因素，但超重或肥胖2型糖尿病患者故意减肥的长期后果尚未得到充分研究。Look AHEAD临床试验的主要目的是评估在超重和肥胖的2型糖尿病患者中实施4年强化减肥计划的长期效果（长达11.5年）。大约5000名年龄在45-74岁之间、体重指数大于或等于25 kg/m2的2型糖尿病男性和女性受试者将被随机分配到两组中的一组。强化生活方式干预旨在通过减少热量摄入和增加体力活动来实现和维持体重减轻。该计划与给予糖尿病支持和教育的控制条件进行比较。主要研究结局是至发生重大CVD事件的时间。该研究旨在提供0.90的概率，检测两组之间主要CVD事件发生率的18%差异。其他结果包括CVD风险、成本和成本效益、糖尿病控制和并发症、住院、干预过程和生活质量的组成部分。(C)2003年爱思唯尔公司All rights reserved.
Overweight and obesity are major contributors to both type 2 diabetes and cardiovascular disease (CVD). Moreover, individuals with type 2 diabetes who are overweight or obese are at particularly high risk for CVD morbidity and mortality. Although short-term weight loss has been shown to ameliorate obesity-related metabolic abnormalities and CVD risk factors, the long-term consequences of intentional weight loss in overweight or obese individuals with type 2 diabetes have not been adequately examined. The primary objective of the Look AHEAD clinical trial is to assess the long-term effects (up to 11.5 years) of an intensive weight loss program delivered over 4 years in overweight and obese individuals with type 2 diabetes. Approximately 5000 male and female participants who have type 2 diabetes, are 45-74 years of age, and have a body mass index greater than or equal to25 kg/m(2) will be randomized to one of the two groups. The intensive lifestyle intervention is designed to achieve and maintain weight loss through decreased caloric intake and increased physical activity. This program is compared to a control condition given diabetes support and education. The primary study outcome is time to incidence of a major CVD event. The study is designed to provide a 0.90 probability of detecting an 18% difference in major CVD event rates between the two groups. Other outcomes include components of CVD risk, cost and cost-effectiveness, diabetes control and complications, hospitalizations, intervention processes, and quality of life. (C) 2003 Elsevier Inc. All rights reserved.