Decrease of Inflammation of Adipose Tissue, Sleep Apnea Syndrome
Conditions
Keywords
adipose tissue, obese patients, inflammation, oxidative stress, sleep apnea syndrome
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).
Interventions
DEVICEcPAP
Patients are randomised in 2 arms : cPAP or sham cPAP
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Hospices Civils de Lyon
University Hospital, Geneva
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| measure of insulin sensitivity | 2 months | Insulin sensitivity will be measured in obese and non-obese patients treated either by cPAP or placebo cPAP |
| Decrease of systemic inflammation | 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 |
| 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 |
| 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 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 |
| 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 |
Countries
France
Outcome results
None listed