Randomized Crossover Study of The Effects of Resveratrol on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change from baseline in Brachial artery flow mediated dilation
研究概览
简要总结
The present study is designed to test the hypothesis that resveratrol supplementation will improve the function of the endothelium in patients with type 2 diabetes mellitus.
The function of the endothelium will be tested with a non-invasive technique that uses ultrasound to measure the amount of dilation that occurs in the brachial artery following 5-minute cuff occlusion. To help us understand potential mechanisms of benefit, we will also collect blood, urine, and cell samples and test the effects of treatment on protein expression, nitric oxide production, and function of mitochondria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects
- •Age over 21 years old
- •Body mass index less than 38 kg/m2
- •Clinical stable type 2 diabetes mellitus
排除标准
- •Women who are lactating or pregnant
- •Treatment with an investigations product within 30 days of screening
- •Clinically evident major illness of other organ systems, including cancer, renal failure, or other conditions in the opinion of the investigators that would make clinical study inappropriate
- •Liver transaminase levels greater than 3 times the upper limit of normal
- •History of psychological illness or condition that would interfere with the subject's ability to understand the requirements of the study
- •Vitamin supplements exceeding two times the recommended daily allowance
- •Resveratrol or other dietary supplements except for a daily multivitamin
研究组 & 干预措施
Active First
Active resveratrol first, placebo second
干预措施: Resveratrol (Dietary Supplement)
Active First
Active resveratrol first, placebo second
干预措施: Placebo (Dietary Supplement)
Placebo first
Placebo first, active resveratrol second
干预措施: Placebo (Dietary Supplement)
Placebo first
Placebo first, active resveratrol second
干预措施: Resveratrol (Dietary Supplement)
结局指标
主要结局
Change from baseline in Brachial artery flow mediated dilation
时间窗: 2 hours, 2 weeks, and 4 weeks
次要结局
- Change from Baseline in Carotid femoral pulse wave velocity(4 weeks)
- Change from Baseline in Reactive hyperemia(2 hours, 2 weeks, 4 weeks)
- Change from Baseline in Fingertip peripheral arterial tonometry(2 hours, 2 weeks, and 4 weeks)