Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 4
- 主要终点
- Absolute Change in Brachial Artery Flow-mediated Dilation (FMD).
研究概览
简要总结
The investigators will examine the possible synergistic effects of obstructive sleep apnea (OSA) and type II diabetes mellitus (DM) on vascular functioning by performing a two-part investigation:
- A cross-sectional study comparing subjects with OSA+DM, OSA only, DM only, and healthy controls.
- A three-month randomized placebo-controlled trial of continuous positive airway pressure (CPAP) in subjects with OSA+DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •OSA subjects: apnea-hypopnea index >=10 and <100
- •DM subjects: clinical diagnosis of DM and glycated hemoglobin < 8.0%
排除标准
- •Hematocrit < 32
- •Pregnancy
- •Infectious/collagen vascular/hepatic or renal/cardiopulmonary disease
研究组 & 干预措施
Active CPAP
Therapeutic continuous positive airway pressure (CPAP).
干预措施: Continuous positive airway pressure (Device)
Sham CPAP
Sham (non-therapeutic) continuous positive airway pressure.
干预措施: Sham continuous positive airway pressure (Device)
结局指标
主要结局
Absolute Change in Brachial Artery Flow-mediated Dilation (FMD).
时间窗: 3 months (compared to baseline)
Brachial artery flow-mediated dilation is measured as the percent change in brachial artery diameter post-occlusion relative to pre-occlusion. The change in brachial artery flow mediated dilation is the difference in this percent change at 3-months compared to baseline.
次要结局
未报告次要终点
研究者
Sanjay R Patel
Principal Investigator
University of Pittsburgh