Inflammation and Oxidative Stress of Adipose Tissue in Sleep Apnea Syndrome

Not Applicable

Terminated

• Conditions: Decrease of Inflammation of Adipose Tissue; Sleep Apnea Syndrome
• Interventions: Device: cPAP

• Registration Number: NCT01196845
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2010-09-06
• Study First Submitted QC: 2010-09-07
• Study First Posted: 2010-09-09
• Study Start: 2010-10-16
• Primary Completion: 2017-02-16
• Study Completion: 2017-02-16
• Status Verified: 2020-01
• Last Update Submitted: 2022-06-03
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-obese + cPAP	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.
obese + cPAP	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.
obese + Sham cPAP	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.
non-obese + Sham cPAP	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.

Primary Outcome Measures

Name	Time	Method
Decrease of inflammation in adipose tissue	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Grenoble; 🇫🇷 Grenoble, France