Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change From Baseline in Area Under the Curve (AUC) Glucose at Week 2
研究概览
简要总结
Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure (CPAP) has metabolic benefits. The objective of this study is to determine the effect of 8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA.
详细描述
Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure (CPAP) has metabolic benefits. To determine the effect of 8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA. In a randomized, controlled parallel group study, 39 participants were randomized (2:1) to receive either 8-hour nightly CPAP (n=26) or oral placebo (n=13). Sleep was polysomnographically recorded in the laboratory on each night. CPAP adherence was ensured by continuous supervision. Participants continued their daily daytime routine activities outside the laboratory. Glucose metabolism was assessed at baseline and after 2-weeks of assigned treatment using both the oral and intravenous glucose tolerance tests (OGTT and ivGTT, respectively). The primary outcome was the overall glucose response as quantified by the area under the curve for glucose during 2-hour oral glucose tolerance testing.
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
- 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
- •Overweight or obese adults (age ≥45 yrs and BMI ≥25 kg/m2)
- •prediabetes and OSA (AHI ≥ 5)
- •regular life styles and schedules (no shift work in the past 6 months, no travel across time zones during the past 4 weeks)
- •habitual bedtimes of at least 6 hours but not exceeding 9 hours will be eligible.
- •not to take any medications during the study period with the exception of antihypertensives and lipid lowering agents
- •not on hormone replacement therapy.
- •have sedentary activities and no competitive athletes or subjects with high exercise levels.
排除标准
- •previous or current treatment with supplemental oxygen
- •requirement of supplemental oxygen or bi-level positive airway pressure for OSA treatment during titration
- •presence of active infection, psychiatric disease or history of other significant illness (e.g., myocardial infarction, congestive heart failure, stroke, arrhythmia, chronic kidney or liver disease0
- •clinical depression as evidenced by a score >16 in CES-D scale
- •smoking, or routine alcohol use (more than 2 drinks per day), or excessive caffeine intake (>300mg per day)
研究组 & 干预措施
Continuous positive airway pressure
2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
干预措施: CPAP mask (Device)
Placebo
2 weeks of oral administration of a placebo tablet 30min before bedtime
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Area Under the Curve (AUC) Glucose at Week 2
时间窗: Baseline and Week 2
The area under the glucose time curve, between 0 and 120 minutes of the OGTT, was calculated for each patient using the trapezoidal rule . Change = Week 2 - Baseline.
次要结局
- Change From Baseline in Insulin Sensitivity (SI) at Week 2(Baseline and Week 2)
- Change From Baseline in 24-hr Systolic Blood Pressure (mmHg) at Week 2(Baseline and Week 2)
- Change From Baseline in 24-hr Diastolic Blood Pressure (mmHg) at Week 2(Baseline and Week 2)