NCT01609088已完成不适用
Pilot Study of the Effects of Erythritol on Endothelial Function in Patients With Type 2 Diabetes Mellitus
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Brachial artery flow mediated dilation
研究概览
简要总结
The study will determine whether acute and chronic consumption of a beverage containing erythritol will improve endothelial function in patients with type 2 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •Otherwise healthy
排除标准
- •BMI>35 kg/m2
- •Long acting insulin treatment
- •Other major illness, drug abuse
- •Treatment with an investigational drug within 12 weeks
- •Treatment with dietary or vitamin supplements
- •Smoking within 3 months
研究组 & 干预措施
Erythritol-containing beverage
Experimental
干预措施: Erythritol-containing beverage (Dietary Supplement)
结局指标
主要结局
Brachial artery flow mediated dilation
时间窗: Change from baseline at 28 days
次要结局
- Brachial artery flow-mediated dilation(Change from baseline at 2 hours)
- Reactive hyperemia(Change from baseline at 2 hours and 28 days)
- Carotid femoral pulse wave velocity(Change from baseline at 28 days)
- Fingertip tonometry(Change from baseline at 2 hours and 28 days)
- Urine F2 isoprostanes(Change from baseline at 28 days)
- C-reactive protein(Change from baseline at 28 days)
研究者
Joseph A. Vita
Professor of Medicine
Boston University
研究点 (1)
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