Inflammation and Oxidative Stress of Adipose Tissue in Sleep Apnea Syndrome

Sleep Apnea Syndrome Clinical Trial

— ADISAS  

Official title:

Inflammation and Oxidative Stress of Adipose Tissue in Obese and Non-obese Patients Having Sleep Apnea Syndrome

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
• 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
• 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

Related Conditions & MeSH terms

• Apnea
• Decrease of Inflammation of Adipose Tissue
• Inflammation
• Panniculitis
• Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Syndrome

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