Clinical trial NCT01196845: Inflammation and Oxidative Stress of Adipose Tissue in Sleep Apnea Syndrome
Official title: Inflammation and Oxidative Stress of Adipose Tissue in Obese and Non-obese Patients Having Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Decrease of Inflammation of Adipose Tissue
Sleep Apnea Syndrome
Keywords: adipose tissue
obese patients
inflammation
oxidative stress
sleep apnea syndrome
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Saint Etienne
name: Hospices Civils de Lyon
name: University Hospital, Geneva
First posted: 2010-09-09
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Decrease of inflammation in adipose tissue
timeFrame: 2 months
Secondary outcomes:
measure: Decrease of oxidative stress
timeFrame: 2 months
measure: measure of insulin sensitivity
timeFrame: 2 months
measure: Decrease of systemic inflammation
timeFrame: 2 months
measure: Measure of local hypoxemia of adipose tissue
timeFrame: 2 months
measure: Measure of structural and functional changes in skeletal muscle
timeFrame: 2 months
measure: Measure of vascular adhesion factors modifications and protein synthesis signals modifications
timeFrame: 2 months
measure: Decrease in endothelial dysfunction
timeFrame: 2 months
measure: Decrease in arterial rigidity
timeFrame: 2 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Jean Louis PEPIN, ProfessorPhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baguet JP, Hammer L, Levy P, Pierre H, Launois S, Mallion JM, Pepin JL. The severity of oxygen desaturation is predictive of carotid wall thickening and plaque occurrence. Chest. 2005 Nov;128(5):3407-12. doi: 10.1378/chest.128.5.3407.
citation: Shamsuzzaman AS, Gersh BJ, Somers VK. Obstructive sleep apnea: implications for cardiac and vascular disease. JAMA. 2003 Oct 8;290(14):1906-14. doi: 10.1001/jama.290.14.1906.
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. doi: 10.2337/db06-0911.
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. doi: 10.1016/S0140-6736(05)71141-7.
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. doi: 10.1183/09031936.00043306. Epub 2007 Jan 24.
citation: Lavie L. Obstructive sleep apnoea syndrome--an oxidative stress disorder. Sleep Med Rev. 2003 Feb;7(1):35-51. doi: 10.1053/smrv.2002.0261.
citation: Jullian-Desayes I, Tamisier R, Zarski JP, Aron-Wisnewsky J, Launois-Rollinat SH, Trocme C, Levy P, Joyeux-Faure M, Pepin JL. Impact of effective versus sham continuous positive airway pressure on liver injury in obstructive sleep apnoea: Data from randomized trials. Respirology. 2016 Feb;21(2):378-85. doi: 10.1111/resp.12672. Epub 2015 Nov 16.