Inflammation and Oxidative Stress of Adipose Tissue in Sleep Apnea Syndrome

N/ATerminatedNCT01196845

University Hospital, Grenoble40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Decrease of Inflammation of Adipose Tissue Sleep Apnea Syndrome

Interventions

cPAPDEVICE

Patients are randomised in 2 arms : cPAP or sham cPAP

cPAPDEVICE

Patients are randomised in 2 arms : cPAP or Sham cPAP

cPAPDEVICE

Patients are randomised in 2 arms : cPAP or sham cPAP

cPAP

Eligibility

Sex: MALEMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Grenoble

Grenoble, France

Outcomes

Primary Outcomes

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.

Time frame: 2 months

Secondary Outcomes

Decrease of oxidative stress

Measures of oxidative stress will be done in obese and non-obese patients treated either by cPAP or "Placebo cPAP"

Time frame: 2 months

measure of insulin sensitivity

Insulin sensitivity will be measured in obese and non-obese patients treated either by cPAP or "placebo cPAP"

Time frame: 2 months

Decrease of systemic inflammation

This measure will be done in obese and non-obese patients treated either by cPAP or "placebo cPAP"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Data from ClinicalTrials.gov

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