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

Primary Purpose

Decrease of Inflammation of Adipose Tissue, Sleep Apnea Syndrome

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cPAP
cPAP
cPAP
cPAP
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Decrease of Inflammation of Adipose Tissue focused on measuring adipose tissue, obese patients, inflammation, oxidative stress, sleep apnea syndrome

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Grenoble

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

obese + cPAP

obese + Sham cPAP

non-obese + cPAP

non-obese + Sham cPAP

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Decrease of oxidative stress
Measures of oxidative stress will be done in obese and non-obese patients treated either by cPAP or "Placebo cPAP"
measure of insulin sensitivity
Insulin sensitivity will be measured in obese and non-obese patients treated either by cPAP or "placebo cPAP"
Decrease of systemic inflammation
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
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
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
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
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
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

Full Information

First Posted
September 6, 2010
Last Updated
June 3, 2022
Sponsor
University Hospital, Grenoble
Collaborators
Centre Hospitalier Universitaire de Saint Etienne, Hospices Civils de Lyon, University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT01196845
Brief Title
Inflammation and Oxidative Stress of Adipose Tissue in Sleep Apnea Syndrome
Acronym
ADISAS
Official Title
Inflammation and Oxidative Stress of Adipose Tissue in Obese and Non-obese Patients Having Sleep Apnea Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Enrollment difficulty
Study Start Date
October 16, 2010 (Actual)
Primary Completion Date
February 16, 2017 (Actual)
Study Completion Date
February 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Centre Hospitalier Universitaire de Saint Etienne, Hospices Civils de Lyon, University Hospital, Geneva

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decrease of Inflammation of Adipose Tissue, Sleep Apnea Syndrome
Keywords
adipose tissue, obese patients, inflammation, oxidative stress, sleep apnea syndrome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
obese + cPAP
Arm Type
Other
Arm Description
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.
Arm Title
obese + Sham cPAP
Arm Type
Other
Arm Description
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.
Arm Title
non-obese + cPAP
Arm Type
Other
Arm Description
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.
Arm Title
non-obese + Sham cPAP
Arm Type
Other
Arm Description
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 Type
Device
Intervention Name(s)
cPAP
Intervention Description
Patients are randomised in 2 arms : cPAP or sham cPAP
Intervention Type
Device
Intervention Name(s)
cPAP
Intervention Description
Patients are randomised in 2 arms : cPAP or Sham cPAP
Intervention Type
Device
Intervention Name(s)
cPAP
Intervention Description
Patients are randomised in 2 arms : cPAP or sham cPAP
Intervention Type
Device
Intervention Name(s)
cPAP
Intervention Description
Patients are randomised in 2 arms : cPAP or sham cPAP
Primary Outcome Measure Information:
Title
Decrease of inflammation in adipose tissue
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Decrease of oxidative stress
Description
Measures of oxidative stress will be done in obese and non-obese patients treated either by cPAP or "Placebo cPAP"
Time Frame
2 months
Title
measure of insulin sensitivity
Description
Insulin sensitivity will be measured in obese and non-obese patients treated either by cPAP or "placebo cPAP"
Time Frame
2 months
Title
Decrease of systemic inflammation
Description
This measure will be done in obese and non-obese patients treated either by cPAP or "placebo cPAP"
Time Frame
2 months
Title
Measure of local hypoxemia of adipose tissue
Description
This measure will be done in obese and non-obese patients treated either by cPAP or "placebo cPAP"
Time Frame
2 months
Title
Measure of structural and functional changes in skeletal muscle
Description
This measure will be done in obese and non-obese patients treated either by cPAP or "placebo cPAP"
Time Frame
2 months
Title
Measure of vascular adhesion factors modifications and protein synthesis signals modifications
Description
This measure will be done in musculus skeletal of obese and non-obese patients treated either by cPAP or "placebo cPAP"
Time Frame
2 months
Title
Decrease in endothelial dysfunction
Description
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
Time Frame
2 months
Title
Decrease in arterial rigidity
Description
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
Time Frame
2 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Louis PEPIN, ProfessorPhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Grenoble
City
Grenoble
ZIP/Postal Code
38000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16304292
Citation
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.
Results Reference
background
PubMed Identifier
14532320
Citation
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.
Results Reference
background
PubMed Identifier
17395738
Citation
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.
Results Reference
background
PubMed Identifier
15781100
Citation
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.
Results Reference
background
PubMed Identifier
17251237
Citation
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.
Results Reference
background
PubMed Identifier
12586529
Citation
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.
Results Reference
background
PubMed Identifier
26567858
Citation
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.
Results Reference
derived

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Inflammation and Oxidative Stress of Adipose Tissue in Sleep Apnea Syndrome

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