Inflammation and Oxidative Stress of Adipose Tissue in Sleep Apnea Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Inflammation and Oxidative Stress of Adipose Tissue in Obese and Non-obese Patients Having Sleep Apnea Syndrome

Conditions
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Decrease of Inflammation of Adipose Tissue, Sleep Apnea Syndrome

Intervention / Treatment
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* Device: cPAP
* Device: cPAP
* Device: cPAP
* Device: cPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: Female 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: obese + cPAP<br>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. | Device: cPAP<br>* Patients are randomised in 2 arms : cPAP or sham cPAP<br>|
| Other: obese + Sham cPAP<br>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. | Device: cPAP<br>* Patients are randomised in 2 arms : cPAP or Sham cPAP<br>|
| Other: non-obese + cPAP<br>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. | Device: cPAP<br>* Patients are randomised in 2 arms : cPAP or sham cPAP<br>|
| Other: non-obese + Sham cPAP<br>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. | Device: cPAP<br>* Patients are randomised in 2 arms : cPAP or sham cPAP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of inflammation in adipose tissue | 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. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of oxidative stress | Measures of oxidative stress will be done in obese and non-obese patients treated either by cPAP or Placebo cPAP | 2 months | 
| measure of insulin sensitivity | Insulin sensitivity will be measured in obese and non-obese patients treated either by cPAP or placebo cPAP | 2 months | 
| Decrease of systemic inflammation | This measure will be done in obese and non-obese patients treated either by cPAP or placebo cPAP | 2 months | 
| Measure of local hypoxemia of adipose tissue | This measure will be done in obese and non-obese patients treated either by cPAP or placebo cPAP | 2 months | 
| Measure of structural and functional changes in skeletal muscle | This measure will be done in obese and non-obese patients treated either by cPAP or placebo cPAP | 2 months | 
| Measure of vascular adhesion factors modifications and protein synthesis signals modifications | This measure will be done in musculus skeletal of obese and non-obese patients treated either by cPAP or placebo cPAP | 2 months | 
| Decrease in endothelial dysfunction | This measure will be done in obese and non-obese patients treated either by cPAP or placebo cPAP and correlated to decrease of inflammation and oxidative stress | 2 months | 
| Decrease in arterial rigidity | This measure will be done in obese and non-obese patients treated either by cPAP or placebo cPAP and correlated to decrease of inflammation and oxidative stress | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adipose tissue, obese patients, inflammation, oxidative stress, sleep apnea syndrome