- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01196845
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
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
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-
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Grenoble, France, 38000
- University Hospital Grenoble
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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.
|
Patients are randomised in 2 arms : cPAP or sham 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.
|
Patients are randomised in 2 arms : cPAP or sham 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.
|
Patients are randomised in 2 arms : cPAP or sham 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.
|
Patients are randomised in 2 arms : cPAP or sham 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"
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2 months
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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"
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2 months
|
Measure of vascular adhesion factors modifications and protein synthesis signals modifications
Time Frame: 2 months
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This measure will be done in musculus skeletal of obese and non-obese patients treated either by cPAP or "placebo cPAP"
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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
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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
Collaborators
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Disease
- Nutrition Disorders
- Connective Tissue Diseases
- Signs and Symptoms, Respiratory
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Vitamin E Deficiency
- Sleep Apnea Syndromes
- Syndrome
- Inflammation
- Apnea
- Panniculitis
- Steatitis
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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