Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 2
- 主要终点
- Change in Continuous Glucose Monitoring System Standard Deviation
研究概览
简要总结
This is a randomized control trial in people with diabetes and obstructive sleep apnea who will be randomly assigned for 3 months to PAP therapy along with healthy lifestyle and sleep education or healthy lifestyle and sleep education.
详细描述
Research over the last decade has shown that obstructive sleep apnea (OSA) is a common condition in people with diabetes. Observational and experimental evidence also indicates that intermittent hypoxemia and recurrent arousals in OSA may alter glucose metabolism and worsen glycemic control. However, the impact of treating OSA with positive airway pressure (PAP) therapy on glycemic variability and control is not well defined. Adequately powered randomized clinical trials have yet to be performed to demonstrate whether PAP therapy for OSA in diabetics can improve glycemic variability (and control), decrease blood pressure, and reverse endothelial dysfunction. The overarching goal of this study is to determine whether PAP therapy for OSA in diabetics leads to improvements in (a) glycemic variability as assessed by self-monitoring of blood glucose and continuous monitoring of glucose; (b) glycosylated hemoglobin; (c) blood pressure; (d) endothelial function; (e) serum and urinary biomarkers; and (f) dyslipidemia.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetics
- •Age > 21 and ≤ 75 years
排除标准
- •Inability to consent or commit to the required visits
- •Use of insulin or other injections for diabetes
- •Weight change of 10% in last six months
- •Use of oral steroids in the last six months
- •Pulmonary disease (i.e., COPD)
- •Renal or hepatic insufficiency
- •Recent MI or stroke (< 3 months)
- •Sleep-related hypoventilation
- •Obesity-hypoventilation syndrome
- •Morbid Obesity
- •Occupation as a commercial driver or operator of heavy machinery
- •Active substance use
- •Untreated thyroid disease
- •Pregnancy
- •Any history of seizures or other neurologic disease
- •Poor sleep hygiene or sleep disorder other than sleep apnea
- •Central sleep apnea
- •Variants of obstructive sleep apnea (e.g., REM-related OSA)
- •Participants not suitable for the study based on the clinical judgment
- •Use of any investigational drug within the past 30 days
- •Participating in another study
结局指标
主要结局
Change in Continuous Glucose Monitoring System Standard Deviation
时间窗: Baseline and 3 months
Continuous Glucose Monitoring Metrics - change in standard deviation between baseline and three months.
次要结局
- Mean Difference in Systolic Blood Pressure(Baseline and 3 months)
- Change in Endothelial Dysfunction as Assessed by the Reactive Hyperemic Index(Baseline and 3 months)
- Change in the Epworth Sleepiness Scale(Baseline and 3 months)
- Change in Glycosylated Hemoglobin A1c Level(Baseline and 3 months)
- Continuous Glucose Monitoring System Mean Amplitude Glucose Excursion(3 months)
- Heart Rate Variability(3 months)
- Change in Post-Pre Meal Blood Glucose Levels(Baseline and 3 months)
- Continuous Glucose Monitoring System Standard Deviation(3 months)
- Change in Continuous Glucose Monitoring System Mean Glucose(Baseline and 3 months)