Metabolic Impact of Intermittent CPAP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Concentration of Plasma Triglycerides (mg/dl)
研究概览
简要总结
Obstructive sleep apnea is a risk factor for diabetes and cardiovascular disease, by unknown mechanisms. The investigators hypothesize that sleep apnea changes glucose and lipid metabolism during sleep, which over time could lead to diabetes and cardiovascular disease. This study examines metabolic changes during sleep in patients with obstructive sleep apnea. Patients accustomed to continuous positive airway pressure (CPAP) therapy are enrolled to undergo sleep studies, either on CPAP therapy or after withdrawing from CPAP for 3 nights. During sleep, blood samples are obtained so that metabolic function can be compared between sleep apnea and CPAP nights.
详细描述
Participants with a history of moderate severe sleep apnea (AHI>20) will be enrolled if participants meet inclusion/exclusion criteria. Investigators will report to the sleep laboratory on two nights, (1) after continuing their CPAP or (2) after discontinuing CPAP for 3 nights. The order of observation will be randomized. A standard research dinner is provided before each study. IV's are placed so that blood can be sampled at frequent (30 min) intervals throughout the night. In the morning after each study, a glucose tolerance test and endothelial function study (endoPAT) are performed. Serum samples will be analyzed for glucose, insulin, free fatty acids, triglycerides, hormones, and other metabolic biomarkers.
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
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of moderate to severe Obstructive sleep apnea (OSA) (AHI or respiratory disturbance index (RDI)> 10).
- •They must also own a CPAP machine and report the ability to tolerate sleeping with or without CPAP during the night.
排除标准
- •Uncontrolled hypertension with systolic blood pressure >170 or diastolic blood pressure > 110
- •Congestive heart failure
- •Use of clonidine or nicotinic acid medication
- •Diabetes requiring the use of insulin
- •Known pregnancy, by urine testing in women of child-bearing age
- •History of falling asleep while driving, near miss
- •High risk occupation (pilot, commercial driver)
- •Hemoglobin < 10 g/dL on point of care screening
结局指标
主要结局
Concentration of Plasma Triglycerides (mg/dl)
时间窗: 2 nights, <1 month apart. Data from each night was averaged to report a single value.
We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Concentration of Plasma Free Fatty Acids (FFA, mmol/L)
时间窗: 2 nights, <1 month apart. Data from each night was averaged to report a single value.
We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Concentration of Plasma Glucose (mg/dl)
时间窗: 2 nights, <1 month apart. Data from each night was averaged to report a single value.
We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Concentration of Plasma Insulin (mcU/ml)
时间窗: 2 nights, <1 month apart. Data from each night was averaged to report a single value.
We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
次要结局
- Oral Glucose Tolerance Test (OGTT)(2 nights, <1 month apart. 5 OGTT values were averaged to a obtain a single value.)
- Augmentation Index (AI)(2 nights, <1 month apart, 1 measurement each visit)
- Reactive Hyperemia Index (RHI)(2 nights, <1 month apart, 1 measurement each visit)