The Effect of Nasal Continuous Positive Airway Pressure Treatment on Glycemic Control and Vascular Function in Patients With Obstructive Sleep Apnea and Type II Diabetes Mellitus.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- HbA1C
研究概览
简要总结
The investigators hypothesize that obstructive sleep apnea (OSA) contributes to impaired glucose homeostasis and associated vasculopathy, and nCPAP treatment of OSA should improve glycemic control and vascular function in OSA patients with type II diabetes mellitus. This study aims to investigate the therapeutic effects of nCPAP on glycemic control and vascular function in patients with OSA and type II diabetes mellitus.
详细描述
Obstructive sleep apnoea (OSA) has been reported to be common (17%) in patients with diabetes mellitus (DM). Both OSA and DM are highly associated with cardiovascular morbidity and mortality. There is growing evidence that OSA may trigger or worsen pre-existing adverse metabolic profile indicative of cardiovascular risk. Treatment of OSA with nasal Continuous Positive Airway Pressure (nCPAP) has been shown to reduce blood pressure and hence to reduce the risk of atherogenesis. In patients with DM, the therapeutic effect of nCPAP is still not known, it would be important to delineate any independent effect of OSA on DM and the therapeutic effect of nCPAP on glycemic control to reduce the long term risk of macrovascular and microvascular complications.
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
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type II DM on a stable medication regimen (on diet / oral hypoglycaemic agents / insulin injections)
- •Age 25 - 70 years
- •HbA1C > 7%
- •Able to give written informed consent
排除标准
- •Patients with severe co-existing illness or poor functional performance
- •Patients with peripheral vascular diseases, vasculitis / Raynaud's syndrome or thrombocytopenia
- •Sleep disorders other than OSA
- •Patients who refuse nCPAP treatment for OSA
- •Excessive sleepiness causing potential harm (e.g. driver)
- •HbA1C >=7%
- •Habitual drinker (defined as more than 3 times a week)
- •Pregnant or lactating women
结局指标
主要结局
HbA1C
时间窗: 3 months
次要结局
- Fasting glucose & fructosamine microalbuminuria blood pressure lipids endothelial function(3 months)
研究者
Lam Jamie Chung Mei
Honorary clinical assistant professor
The University of Hong Kong