The Diabetes Prevention Program. Design and methods for a clinical trial in the prevention of type 2 diabetes.-猫眼课题宝

DOI：

10.2337/diacare.22.4.623

发表时间：

1999

期刊：

Diabetes care

影响因子：

16.2

通讯作者：

中科院分区：

医学1区

文献类型：

作者：

G. Bray;K. Polonsky;P. G. Watson;R. Goldberg;S. Haffner;R. Hamman;E. Horton;S. F. Kahn;A. Kitabchi;B. Metzger;D. Nathan;J. Olefsky;F. Pi‐Sunyer;M. Prince;R. Ratner;M. Saad;S. Jack;C. Saudek;D. Schade;H. Shamoon;R. Wing;R. Arakaki;W. C. Krowler;Bain Rp;S. Marcovina;P. Rautaharju;E. Mayer‐Davis;D. O'leary;E. Stamm

糖尿病预防计划是一项随机临床试验，旨在检测预防或延缓空腹血糖浓度升高和糖耐量受损的高危人群发生2型糖尿病的策略。美国的27个临床中心招募了至少3,000名男女参与者，其中约50%是少数民族患者，20%年龄≥ 65岁，随机分配到三个干预组之一：一个集中于健康饮食和锻炼的强化生活方式干预和两个盲态药物治疗组--二甲双胍或安慰剂--结合标准饮食和锻炼建议。参与者的招募期为2年2/3，在招募结束后，所有参与者将再接受3年1/3至5年的随访，直至2002年的一个共同结束日期。主要结果是糖尿病的发展，通过空腹或激发后血糖浓度符合1997年美国糖尿病协会标准进行诊断。3，000名参与者将提供90%的把握度，以检测安慰剂组中每年至少6.5%的预期糖尿病发病率降低33%。次要结局包括心血管疾病及其危险因素;糖尿病、β细胞功能、胰岛素敏感性、肥胖、饮食、体力活动和健康相关生活质量的变化;以及不良事件的发生。第四个治疗组-曲格列酮结合标准饮食和运动建议-最初被纳入，但由于药物的肝毒性而停止。这项随机临床试验将测试预防或延迟高危人群2型糖尿病发作的可能性。

The Diabetes Prevention Program is a randomized clinical trial testing strategies to prevent or delay the development of type 2 diabetes in high-risk individuals with elevated fasting plasma glucose concentrations and impaired glucose tolerance. The 27 clinical centers in the U.S. are recruiting at least 3,000 participants of both sexes, approximately 50% of whom are minority patients and 20% of whom are > or = 65 years old, to be assigned at random to one of three intervention groups: an intensive lifestyle intervention focusing on a healthy diet and exercise and two masked medication treatment groups--metformin or placebo--combined with standard diet and exercise recommendations. Participants are being recruited during a 2 2/3-year period, and all will be followed for an additional 3 1/3 to 5 years after the close of recruitment to a common closing date in 2002. The primary outcome is the development of diabetes, diagnosed by fasting or post-challenge plasma glucose concentrations meeting the 1997 American Diabetes Association criteria. The 3,000 participants will provide 90% power to detect a 33% reduction in an expected diabetes incidence rate of at least 6.5% per year in the placebo group. Secondary outcomes include cardiovascular disease and its risk factors; changes in glycemia, beta-cell function, insulin sensitivity, obesity, diet, physical activity, and health-related quality of life; and occurrence of adverse events. A fourth treatment group--troglitazone combined with standard diet and exercise recommendations--was included initially but discontinued because of the liver toxicity of the drug. This randomized clinical trial will test the possibility of preventing or delaying the onset of type 2 diabetes in individuals at high risk.

The Diabetes Prevention Program. Design and methods for a clinical trial in the prevention of type 2 diabetes.

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