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

June 3, 2022 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • University Hospital Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Device: cPAP
Patients are randomised in 2 arms : cPAP or Sham cPAP
Other: 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
Device: cPAP
Patients are randomised in 2 arms : cPAP or Sham cPAP
Other: 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
Device: cPAP
Patients are randomised in 2 arms : cPAP or Sham cPAP
Other: 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
Device: cPAP
Patients are randomised in 2 arms : cPAP or Sham cPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease of inflammation in adipose tissue
Time Frame: 2 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease of oxidative stress
Time Frame: 2 months
Measures of oxidative stress will be done in obese and non-obese patients treated either by cPAP or "Placebo cPAP"
2 months
measure of insulin sensitivity
Time Frame: 2 months
Insulin sensitivity will be measured in obese and non-obese patients treated either by cPAP or "placebo cPAP"
2 months
Decrease of systemic inflammation
Time Frame: 2 months
This measure will be done in obese and non-obese patients treated either by cPAP or "placebo cPAP"
2 months
Measure of local hypoxemia of adipose tissue
Time Frame: 2 months
This measure will be done in obese and non-obese patients treated either by cPAP or "placebo cPAP"
2 months
Measure of structural and functional changes in skeletal muscle
Time Frame: 2 months
This measure will be done in obese and non-obese patients treated either by cPAP or "placebo cPAP"
2 months
Measure of vascular adhesion factors modifications and protein synthesis signals modifications
Time Frame: 2 months
This measure will be done in musculus skeletal of obese and non-obese patients treated either by cPAP or "placebo cPAP"
2 months
Decrease in endothelial dysfunction
Time Frame: 2 months
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
Decrease in arterial rigidity
Time Frame: 2 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Hospices Civils de Lyon
Centre Hospitalier Universitaire de Saint Etienne
University Hospital, Geneva

Investigators

  • Principal Investigator: Jean Louis PEPIN, ProfessorPhD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2010

Primary Completion (Actual)

February 16, 2017

Study Completion (Actual)

February 16, 2017

Study Registration Dates

First Submitted

September 6, 2010

First Submitted That Met QC Criteria

September 7, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Actual)

June 8, 2022

Last Update Submitted That Met QC Criteria

June 3, 2022

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-CHUG-25
  • 2009-A00826-51 (Registry Identifier: ID RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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