NCT00962962已完成不适用
Exercise Dose-Response Effects in Prediabetes: Responses and Mechanisms
Duke University2 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2009年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 288
- 试验地点
- 2
- 主要终点
- Fasting Plasma Glucose
研究概览
简要总结
The purpose of the study is to evaluate the effects of different amounts and intensities of aerobic exercise training programs, with and without weight loss, in people who are at risk for diabetes. An additional purpose of the study is to evaluate the factors in the blood and in exercising muscles that contribute to the improvement in those risk factors. This information will be used to improve exercise training guidelines for improving cardiovascular and metabolic health in people with abnormal fasting glucose, also known as prediabetes.
详细描述
729 subjects were consented, 288 participants were randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 45-75 years
- •Moderately Overweight determined by Body Mass Index: 25.0 - 35.4
- •Fasting plasma glucose: > 95 - < 126 mg/dL until 2/15/2012 when lower limit was adjusted to > 100 mg/dL
- •o Readings from two separate days, both being > 95 (> 100 after 2/15/2012)and one of the two being < 126
- •Low density (LDL) cholesterol: < 190 mg/dL
- •Triglycerides: < 600 mg/dL
- •Resting blood pressure: < 160/90 mmHg
- •Inactive: Exercise < one day/week; Peak oxygen consumption: > 18.0 - < 40.0 ml/kg/min until 2/15/2012 when lower limit was adjusted to 12.0 ml/kg/min
- •Medications: Stable use of all medications for > three months
排除标准
- •Smoker: Tobacco use within the last 12 months
- •Dieting or intending to diet
- •Use of potential confounding medications, e.g. Niacin containing drugs
- •History of diabetes, heart disease or taking medication for those conditions
- •History of hypertension (high blood pressure) not controlled with medication
- •Pregnant or intending to become pregnant
- •Unwillingness to undergo a three month control/run-in period, be randomized to any one of four intervention groups, submit to thigh muscle biopsies and all other study testing or continuously participate in a randomly assigned exercise training or lifestyle intervention program for six months
- •Orthopedic limitations, musculoskeletal disease and/or injury
- •Allergic to xylocaine (anesthetic or numbing medicine)
- •Inability to give blood continuously through a catheter (please notify the study nurse of any difficulty you have experienced in the past when having your blood drawn; the study nurse will determine whether you are excluded for this reason)
- •Unwillingness to exercise at least twice per week at the Duke Center for Living Health and Fitness Center during research study staff supervised times
结局指标
主要结局
Fasting Plasma Glucose
时间窗: 3 month control and 6 months intervention
次要结局
- Measures of Glucose control(3 month control and 6 month intervention)
研究者
研究点 (2)
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