Inflammation and Oxidative Stress of Adipose Tissue in Sleep Apnea Syndrome (ADISAS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University Hospital, Grenoble.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Centre Hospitalier Universitaire de Saint Etienne
Hospices Civils de Lyon
University Hospital, Geneva
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01196845
First received: September 6, 2010
Last updated: September 7, 2010
Last verified: September 2010
  Purpose

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).


Condition Intervention
Decrease of Inflammation of Adipose Tissue
Sleep Apnea Syndrome
Device: cPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Inflammation and Oxidative Stress of Adipose Tissue in Obese and Non-obese Patients Having Sleep Apnea Syndrome

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Decrease of inflammation in adipose tissue [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Obese and non-obese patients having a sleep apnea syndrom 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.


Secondary Outcome Measures:
  • Decrease of oxidative stress [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Measures of oxidative stress will be done in obese and non-obese patients treated either by cPAP or "Placebo cPAP"

  • measure of insulin sensitivity [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Insulin sensitivity will be measured in obese and non-obese patients treated either by cPAP or "placebo cPAP"

  • Decrease of systemic inflammation [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    This measure will be done in obese and non-obese patients treated either by cPAP or "placebo cPAP"

  • Measure of local hypoxemia of adipose tissue [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    This measure will be done in obese and non-obese patients treated either by cPAP or "placebo cPAP"

  • Measure of structural and functional changes in skeletal muscle [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    This measure will be done in obese and non-obese patients treated either by cPAP or "placebo cPAP"

  • Measure of vascular adhesion factors modifications and protein synthesis signals modifications [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    This measure will be done in musculus skeleti of obese and non-obese patients treated either by cPAP or "placebo cPAP"

  • Decrease in endothelial dysfunction [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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

  • Decrease in arterial rigidity [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 80
Study Start Date: July 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
obese + cPAP
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
Patients are randomised in 2 arms : cPAP or sham cPAP
obese + Sham cPAP
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
Patients are randomised in 2 arms : cPAP or Sham cPAP
non-obese + cPAP
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
Patients are randomised in 2 arms : cPAP or sham cPAP
non-obese + Sham cPAP
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
Patients are randomised in 2 arms : cPAP or sham cPAP

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

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196845

Contacts
Contact: Jean Louis PEPIN, ProfessorPhD 0033476765516 ext 65516 JPepin@chu-grenoble.fr

Locations
France
University Hospital Grenoble Recruiting
Grenoble, France, 38000
Contact: Jean Louis PEPIN, ProfessorPhD    0033476765516    JPepin@chu-grenoble.fr   
Contact: Renaud TAMISIER    0033476768469    RTamisier@chu-grenoble.fr   
Sub-Investigator: Patrick LEVY, ProfessorPhD         
Sub-Investigator: Renaud TAMISIER, MD         
Sub-Investigator: Sandrine LAUNOIS ROLLINAT, MD         
Sub-Investigator: Jean Philippe BAGUET, ProfessorPhD         
Sub-Investigator: Serge HALIMI, ProfessorPhD         
Sub-Investigator: Patrice FAURE, ProfessorPhD         
Sub-Investigator: Denis MONNERET, MD         
Sub-Investigator: Bernard WUYAM, MD         
Sub-Investigator: Anne Laure BOREL, MD         
Sponsors and Collaborators
University Hospital, Grenoble
Centre Hospitalier Universitaire de Saint Etienne
Hospices Civils de Lyon
University Hospital, Geneva
Investigators
Principal Investigator: Jean Louis PEPIN, ProfessorPhD University Hospital, Grenoble
  More Information

Publications:
Responsible Party: PEPIN Jean Louis, University Hospital of Grenoble
ClinicalTrials.gov Identifier: NCT01196845     History of Changes
Other Study ID Numbers: 09-CHUG-25, 2009-A00826-51
Study First Received: September 6, 2010
Last Updated: September 7, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
adipose tissue
obese patients
inflammation
oxidative stress
sleep apnea syndrome

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Apnea
Inflammation
Syndrome
Steatitis
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Pathologic Processes
Disease
Vitamin E Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on October 19, 2014