Inflammation and Oxidative Stress of Adipose Tissue in Sleep Apnea Syndrome

NCT01196845 | Terminated

• 2 other identifiers: 09-CHUG-252009-A00826-51
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea Syndrome; Decrease of Inflammation of Adipose Tissue

Keywords

adipose tissue; obese patients; inflammation; oxidative stress; sleep apnea syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Decrease of oxidative stress

  2 months

• measure of insulin sensitivity

  2 months

• Decrease of systemic inflammation

  2 months

• Measure of local hypoxemia of adipose tissue

  2 months

• Measure of structural and functional changes in skeletal muscle

  2 months

Study Arms (4)

obese + cPAP

OTHER

Patients with sleep apnea syndrome will be first randomised in 2 arms according to their obesity. They will be secondly randomised in 2 arms receiving either cPAP treatment or Sham cPAP.

Device: cPAP

obese + Sham cPAP

OTHER

Patients with sleep apnea syndrome will be first randomised in 2 arms according to their obesity. They will be secondly randomised in 2 arms receiving either cPAP treatment or Sham cPAP.

Device: cPAP

non-obese + cPAP

OTHER

Patients with sleep apnea syndrome will be first randomised in 2 arms according to their obesity. They will be secondly randomised in 2 arms receiving either cPAP treatment or Sham cPAP.

Device: cPAP

non-obese + Sham cPAP

OTHER

Patients with sleep apnea syndrome will be first randomised in 2 arms according to their obesity. They will be secondly randomised in 2 arms receiving either cPAP treatment or Sham cPAP.

Device: cPAP

Interventions

cPAP DEVICE

Patients are randomised in 2 arms : cPAP or sham cPAP

obese + cPAP

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Centre Hospitalier Universitaire de Saint Etienne: collaborator
• Hospices Civils de Lyon: collaborator
• University Hospital, Geneva: collaborator

Study Sites (1)

University Hospital Grenoble

Grenoble, 38000, France

Location

Related Publications (7)

• 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.

  PMID: 16304292 BACKGROUND

• 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.

  PMID: 14532320 BACKGROUND

• 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.

  PMID: 17395738 BACKGROUND

• 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.

  PMID: 15781100 BACKGROUND

• 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.

  PMID: 17251237 BACKGROUND

• 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.

  PMID: 12586529 BACKGROUND

• 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.

  PMID: 26567858 RESULT

MeSH Terms

Conditions

Sleep Apnea Syndromes; Inflammation

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean Louis PEPIN, ProfessorPhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2010
• First Posted: September 9, 2010
• Study Start: October 16, 2010
• Primary Completion: February 16, 2017
• Study Completion: February 16, 2017
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

FR (1)