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
Recruitment status was Recruiting
Sponsor:
University Hospital, Grenoble
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
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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
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:
|
Apnea Inflammation Sleep Apnea Syndromes Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Pathologic Processes Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013