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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01196845
Recruitment Status : Active, not recruiting
First Posted : September 9, 2010
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
Centre Hospitalier Universitaire de Saint Etienne
Hospices Civils de Lyon
University Hospital, Geneva
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date  ICMJE September 6, 2010
First Posted Date  ICMJE September 9, 2010
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE October 16, 2010
Actual Primary Completion Date October 17, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2010)
Decrease of inflammation in adipose tissue [ Time Frame: 2 months ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2016)
  • 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"
  • 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"
  • 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"
  • 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"
  • 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"
  • 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"
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2010)
  • 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"
  • 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"
  • 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"
  • 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"
  • 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"
  • Measure of vascular adhesion factors modifications and protein synthesis signals modifications [ Time Frame: 2 months ]
    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 ]
    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 ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inflammation and Oxidative Stress of Adipose Tissue in Sleep Apnea Syndrome
Official Title  ICMJE Inflammation and Oxidative Stress of Adipose Tissue in Obese and Non-obese Patients Having Sleep Apnea Syndrome
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE
  • Decrease of Inflammation of Adipose Tissue
  • Sleep Apnea Syndrome
Intervention  ICMJE
  • Device: cPAP
    Patients are randomised in 2 arms : cPAP or sham cPAP
  • Device: cPAP
    Patients are randomised in 2 arms : cPAP or Sham cPAP
Study Arms  ICMJE
  • 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.
    Intervention: Device: 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.
    Intervention: Device: 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.
    Intervention: Device: 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.
    Intervention: Device: cPAP
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 7, 2010)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date October 17, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01196845
Other Study ID Numbers  ICMJE 09-CHUG-25
2009-A00826-51 ( Registry Identifier: ID RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Grenoble
Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE
  • Centre Hospitalier Universitaire de Saint Etienne
  • Hospices Civils de Lyon
  • University Hospital, Geneva
Investigators  ICMJE
Principal Investigator: Jean Louis PEPIN, ProfessorPhD University Hospital, Grenoble
PRS Account University Hospital, Grenoble
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP