Effects of Continuous Positive Airway Pressure (CPAP) Treatment on Glucose Control in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in Mean Serum Insulin Derived From 24 Hour Blood Sampling
研究概览
简要总结
The overall goal of the proposed protocol is to rigorously test the hypothesis that CPAP treatment has beneficial effects on glycemic control in patients with both type 2 diabetes (T2DM) and obstructive sleep apnea (OSA). If our hypothesis were to be proven, this would imply that CPAP treatment of OSA in patients with T2DM is an essential component of their glycemic control. The proposed work is thus expected to provide additional preventive and therapeutic approaches in the management of millions of patients with T2DM.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects with type 2 diabetes on a stable medication regimen (no change in diabetic medications in the previous 3 months) will be eligible.
排除标准
- •Subjects on insulin will be excluded.
- •Subjects with unstable cardiopulmonary disease, painful neuropathy, significant psychiatric illness, cognitive impairment and pregnancy will be excluded.
- •Shift workers
- •Subjects having traveled across >2 time zones less than one month prior to the study
- •Diagnosis of a sleep disorder other than OSA by screening polysomnography
- •Previous treatment with positive airway pressure or supplemental oxygen
- •Requirement of supplemental oxygen or bi-level positive airway pressure for OSA treatment during titration
- •Claustrophobia or other conditions of CPAP intolerance,
- •Presence of active infection.
结局指标
主要结局
Change in Mean Serum Insulin Derived From 24 Hour Blood Sampling
时间窗: after 1 week of therapy in the laboratory
Serum insulin levels will be measured on each sample collected during 24-h sampling at baseline and at the end of the 7-day intervention. Mean insulin level over 24 hours will be calculated for each participant at baseline and at the end of the intervention. For each participant, we will calculate the change in mean insulin level from baseline.
Change From Baseline to End of 7-day Intervention in Mean Plasma Glucose Derived From 24 Hour Blood Sampling
时间窗: after 1 week of CPAP therapy in the laboratory
24 hour blood sampling will be performed at baseline and at the end of the 7-day intervention. Glucose levels will be measured on each sample. Mean glucose level for all baseline samples will be calculated for each participant. Mean glucose levels for all samples collected at the end of the intervention will be calculated. Change in mean glucose level from baseline to end of intervention will be calculated for each participant.
Change From Baseline in Mean Glucose From Continuous Interstitial Glucose Monitoring Over 36-40 Hours
时间窗: change in mean interstitial glucose after 1 week of active or sham CPAP therapy in the laboratory
Continuous Glucose monitoring will provide interstitial glucose levels for 36-40 hours at baseline and after one week of active or sham CPAP therapy. The mean glucose level of all samples collected at baseline will be calculated for each participant. The mean glucose level of all samples collected at the end of the 7-day intervention will be calculated for each participant. For each participant, we will calculate the change in mean glucose level from baseline till end of the intervention.
次要结局
- 24-hr Profile of Plasma Growth Hormone(after 1 week of active CPAP therapy in the laboratory)
- Change in Mean Plasma Cortisol Level From 24-h Sampling(after 1 week of active CPAP therapy in the laboratory)
- Change in 24-h Mean Level of Plasma Norepinephrine(after 1 week of active CPAP therapy in the laboratory)