Inflammation and Oxidative Stress of Adipose Tissue in Obese and Non-obese Patients Having Sleep Apnea Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Decrease of inflammation in adipose tissue
研究概览
简要总结
The main objective of this study is to evaluate the decrease of inflammation of adipose tissue in obese and non-obese patients having a sleep apnea syndrome and treated or not by continuous positive airway pressure (cPAP).
An interim analysis will be performed when 40 patients will be included.
详细描述
Inflammation of adipose tissue will be evaluated by RT-PCR on mRNA of pro and anti-inflammatory cytokines (IL-1, IL-6, IL-4, IL-10, IL-12, RANTES, TNFa, leptin, adiponectin, CD68).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male between 18 and 70 years old
- •Apnea Hypopnea Index > 30/h and > 5% TST with SaO2 < 90%
- •patients obese (BMI > 33kg/m2) or non obese (BMI < 27kg/m2)
排除标准
- •coronary ischemic disease, past history of CVA
- •chronic pulmonary disease measured by arterial gasometry (PaO2 < 60mmHg and/or PaCO2 > 45mmHg)
- •known hepatic disease
- •alcohol consumption > 3 units/day
- •sleepiness considered to be dangerous by the investigator
- •patient having an hazardous work regarding to awareness
- •patient being under anticoagulant, antiplatelet drug or having an active stent or bleeding disorder
- •patient having an inflammatory syndrome (C-reactive Protein > 10)
- •any allergy to local anaesthetics
- •chronic muscle pain
- •contraindication to MRI
研究组 & 干预措施
obese + cPAP
Patients with sleep apnea syndrome will be first randomised in 2 arms according to their obesity. They will be secondly randomised in 2 arms receiving either cPAP treatment or Sham cPAP.
干预措施: cPAP (Device)
obese + Sham cPAP
Patients with sleep apnea syndrome will be first randomised in 2 arms according to their obesity. They will be secondly randomised in 2 arms receiving either cPAP treatment or Sham cPAP.
干预措施: cPAP (Device)
non-obese + cPAP
Patients with sleep apnea syndrome will be first randomised in 2 arms according to their obesity. They will be secondly randomised in 2 arms receiving either cPAP treatment or Sham cPAP.
干预措施: cPAP (Device)
non-obese + Sham cPAP
Patients with sleep apnea syndrome will be first randomised in 2 arms according to their obesity. They will be secondly randomised in 2 arms receiving either cPAP treatment or Sham cPAP.
干预措施: cPAP (Device)
结局指标
主要结局
Decrease of inflammation in adipose tissue
时间窗: 2 months
Obese and non-obese patients having a sleep apnea syndrome will be treated by cPAP or not (placebo arm). Decrease of inflammation in adipose tissue is expected to be observed in patients treated by cPAP.
次要结局
- measure of insulin sensitivity(2 months)
- Measure of structural and functional changes in skeletal muscle(2 months)
- Measure of local hypoxemia of adipose tissue(2 months)
- Measure of vascular adhesion factors modifications and protein synthesis signals modifications(2 months)
- Decrease in endothelial dysfunction(2 months)
- Decrease of systemic inflammation(2 months)
- Decrease of oxidative stress(2 months)
- Decrease in arterial rigidity(2 months)