Sleep Apnea Syndrome Clinical Trial
— ADISASOfficial title:
Inflammation and Oxidative Stress of Adipose Tissue in Obese and Non-obese Patients Having Sleep Apnea Syndrome
Verified date | January 2020 |
Source | University Hospital, Grenoble |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 40 |
Est. completion date | February 16, 2017 |
Est. primary completion date | February 16, 2017 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 69 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | University Hospital Grenoble | Grenoble |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble | Centre Hospitalier Universitaire de Saint Etienne, Hospices Civils de Lyon, University Hospital, Geneva |
France,
Baguet JP, Hammer L, Lévy P, Pierre H, Launois S, Mallion JM, Pépin JL. The severity of oxygen desaturation is predictive of carotid wall thickening and plaque occurrence. Chest. 2005 Nov;128(5):3407-12. — View Citation
Coughlin SR, Mawdsley L, Mugarza JA, Wilding JP, Calverley PM. Cardiovascular and metabolic effects of CPAP in obese males with OSA. Eur Respir J. 2007 Apr;29(4):720-7. Epub 2007 Jan 24. — View Citation
Hosogai N, Fukuhara A, Oshima K, Miyata Y, Tanaka S, Segawa K, Furukawa S, Tochino Y, Komuro R, Matsuda M, Shimomura I. Adipose tissue hypoxia in obesity and its impact on adipocytokine dysregulation. Diabetes. 2007 Apr;56(4):901-11. — View Citation
Lavie L. Obstructive sleep apnoea syndrome--an oxidative stress disorder. Sleep Med Rev. 2003 Feb;7(1):35-51. Review. — View Citation
Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. — View Citation
Shamsuzzaman AS, Gersh BJ, Somers VK. Obstructive sleep apnea: implications for cardiac and vascular disease. JAMA. 2003 Oct 8;290(14):1906-14. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | measure of insulin sensitivity | Insulin sensitivity will be measured in obese and non-obese patients treated either by cPAP or "placebo cPAP" | 2 months | |
Secondary | Decrease of systemic inflammation | This measure will be done in obese and non-obese patients treated either by cPAP or "placebo cPAP" | 2 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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