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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01196845
Other study ID # 09-CHUG-25
Secondary ID 2009-A00826-51
Status Terminated
Phase N/A
First received
Last updated
Start date October 16, 2010
Est. completion date February 16, 2017

Study information

Verified date January 2020
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
cPAP
Patients are randomised in 2 arms : cPAP or sham cPAP
cPAP
Patients are randomised in 2 arms : cPAP or Sham cPAP
cPAP
Patients are randomised in 2 arms : cPAP or sham cPAP
cPAP
Patients are randomised in 2 arms : cPAP or sham cPAP

Locations

Country Name City State
France University Hospital Grenoble Grenoble

Sponsors (4)

Lead Sponsor Collaborator
University Hospital, Grenoble Centre Hospitalier Universitaire de Saint Etienne, Hospices Civils de Lyon, University Hospital, Geneva

Country where clinical trial is conducted

France, 

References & Publications (6)

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

Outcome

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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