Baseline characteristics of the randomised cohort from the Look AHEAD (Action for Health in Diabetes) study.
Baseline characteristics of the randomised cohort from the Look AHEAD (Action for Health in Diabetes) study.
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DOI：
10.3132/dvdr.2006.031
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发表时间：
2006-12-01
影响因子：
2.4
通讯作者：
Wing, Rena
中科院分区：
文献类型：
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作者：
Bray, George;Gregg, Edward;Wing, Rena
目的：前瞻（糖尿病健康行动）研究是一项在超重和肥胖的2型糖尿病患者中进行的16个中心的随机临床试验，旨在评估长期效果。（长达11.5年）的强化减肥干预对主要心血管事件发生时间的影响。资格要求是年龄在45 - 74岁的个体中诊断为2型糖尿病（通过自我报告和验证确定）并且身体质量指数（BMI）> 25 kg/m2（如果目前正在服用胰岛素，则> 27 kg/m2）。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。该研究旨在提供90%的概率检测到随机分配到强化生活方式干预的患者与接受标准糖尿病支持和教育的对照组相比，主要心血管疾病事件发生率有18%的差异。2001年至2004年间随机分配的5，145名参与者中，63.3%为白色，15.6%为非裔美国人，13.2%为西班牙裔，5.0%为美洲印第安人，1.0%为亚裔美国人。这与1999-2000年国家健康和营养调查（NHANES）中糖尿病的种族分布密切相关。入组时的平均年龄为59+/-6.8岁（平均值+/-SD），60%为女性。45 - 55岁年龄段占31.5%，51.5%为56 - 65岁，17.0%为66 - 76岁。大约15.4%的参与者在随机化时正在服用胰岛素，14.0%的参与者有心血管疾病史。有心血管疾病史的男性（21.3%）多于女性（9.2%）。少数参与者（4.4%）是目前的吸烟者，而1999-2000年NHANES调查中的吸烟者比例为16.2%。此外，65.0%的参与者有一级亲属患有糖尿病。总体而言，基线时BMI平均为36+/-5.9 kg/m2，83.6%的男性和86.1%的女性BMI > 30 kg/m2，17.9%的男性和25.4%的女性BMI > 40 kg/m2。Look AHEAD研究成功地随机化了一大批患有2型糖尿病的参与者，这些参与者的年龄分布广泛，肥胖，种族和种族背景，并将检查生活方式干预对主要心血管事件发生率的影响。
OBJECTIVE: The Look AHEAD (Action for Health in Diabetes) study is a 16-centre randomised clinical trial in overweight and obese individuals with type 2 diabetes, designed to evaluate the long-term effects (up to 11.5 years) of intensive weight loss intervention on the time to incidence of major cardiovascular events.RESEARCH DESIGN AND METHODS: Eligibility requirements are diagnosis of type 2 diabetes (determined by self-report and verification) in individuals aged 4574 years and body mass index (BMI) > 25 kg/m2 (> 27 kg/m2 if currently taking insulin). The intensive lifestyle intervention is designed to achieve and maintain weight loss through decreased caloric intake and increased physical activity. The study is designed to provide 90% probability of detecting an 18% difference in major cardiovascular disease event rates in patients randomised to the intensive lifestyle intervention compared to the control group receiving standard diabetes support and education.RESULTS: The 5,145 participants who were randomised between 2001 and 2004 were 63.3% white, 15.6% African-American, 13.2% Hispanic, 5.0% American Indian and 1.0% Asian-American, which closely paralleled the ethnic distribution of diabetes in the National Health and Nutrition Examination Survey (NHANES) 1999-2000 survey. Their average age at entry was 59+/-6.8 years (mean+/-SD), and 60% were women. There were 31.5% between 4555 years of age, 51.5% were 5665, and 17.0% were 6676 years of age. Some 15.4% of participants were taking insulin at the time of randomisation and 14.0% had a history of cardiovascular disease. More men (21.3%) than women (9.2%) had a history of cardiovascular disease. Few participants (4.4%) were current cigarette smokers, compared to 16.2% in the NHANES 1999-2000 survey. Furthermore, 65.0% of participants had a first-degree relative with diabetes. Overall, BMI averaged 36+/-5.9 kg/m2 at baseline, with 83.6% of the men and 86.1% of women having a BMI > 30 kg/m2 and 17.9% of men and 25.4% of women having a BMI > 40 kg/m2.CONCLUSIONS: The Look AHEAD study has successfully randomised a large cohort of participants who have type 2 diabetes with a wide distribution of age, obesity, ethnicity and racial background and will examine the effects of lifestyle intervention on the incidence of major cardiovascular events.