Diabetes Prevention Program
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,234
- 试验地点
- 1
- 主要终点
- Development of diabetes
研究概览
简要总结
The Diabetes Prevention Program is a nationwide clinical study to answer the question: Can Type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or delayed? The study has recruited volunteers, who are at high risk of developing diabetes, at twenty-five medical centers in the United States. It is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, and other Institute and corporate sponsors. Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes in persons with impaired glucose tolerance (IGT). Each person in the study will be followed for 3 to 6 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Impaired glucose tolerance (fasting plasma glucose 95-125 mg/dL and 2hr plasma glucose 140-199 mg/dL)
- •BMI >= 24 kg/m2
排除标准
- •Underlying disease likely to limit life span and/or increase risk of interventions
- •Conditions or behaviors likely to effect conduct of the DPP
- •Diabetes or disordered glucose metabolism
- •Suboptimally treated Thyroid disease
- •Fasting triglyceride level < 600 mg/dl
- •Exclusions related to medications
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Metformin
干预措施: Metformin (Drug)
Intensive Lifestyle
干预措施: Intensive lifestyle (Behavioral)
结局指标
主要结局
Development of diabetes
时间窗: Up to 5 years
Diabetes was diagnosed on the basis of an annual oral glucose-tolerance test or a semiannual fasting plasma glucose test, according to the 1997 criteria of the American Diabetes Association
次要结局
未报告次要终点