AzTrials
AzTrials

Decrease of Inflammation of Adipose TissueADISASNCT01196845

Inflammation and Oxidative Stress of Adipose Tissue in Sleep Apnea Syndrome

A study testing cPAP in people with Decrease of Inflammation of Adipose Tissue and Sleep Apnea Syndrome, run by University Hospital, Grenoble at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 69 years, men only
What is being tested?
cPAP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteFrance
Study dates
16 Oct 2010to 16 Feb 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 69 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • University Hospital Grenoble

    Grenoble, 38000

Other trials in France

About this study

Official title: 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.

Read the 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).

Being tested
cPAP
Keywords
adipose tissue, obese patients, inflammation, oxidative stress, sleep apnea syndrome
Medical subject headings
Sleep Apnea Syndromes, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cPAPDevice

    Patients are randomised in 2 arms : cPAP or sham cPAP

  • cPAPDevice

    Patients are randomised in 2 arms : cPAP or Sham cPAP

  • cPAPDevice

    Patients are randomised in 2 arms : cPAP or sham cPAP

  • cPAPDevice

    Patients are randomised in 2 arms : cPAP or sham cPAP

Study groups in NCT01196845
Study groupRoleWhat they receive
obese + cPAPOtherPatients 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.
Receives: Device: cPAP
obese + Sham cPAPOtherPatients 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.
Receives: Device: cPAP
non-obese + cPAPOtherPatients 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.
Receives: Device: cPAP
non-obese + Sham cPAPOtherPatients 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.
Receives: Device: cPAP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 months

Secondary outcomes (8)

  1. Decrease of oxidative stress

    Measures of oxidative stress will be done in obese and non-obese patients treated either by cPAP or "Placebo cPAP"

    Measured: 2 months

  2. measure of insulin sensitivity

    Insulin sensitivity will be measured in obese and non-obese patients treated either by cPAP or "placebo cPAP"

    Measured: 2 months

  3. Decrease of systemic inflammation

    This measure will be done in obese and non-obese patients treated either by cPAP or "placebo cPAP"

    Measured: 2 months

  4. 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"

    Measured: 2 months

  5. 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"

    Measured: 2 months

  6. 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"

    Measured: 2 months

  7. 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

    Measured: 2 months

  8. 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

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2010 (estimated)
  2. Study start16 Oct 2010
  3. Primary completion16 Feb 2017
  4. Study completion16 Feb 2017

Why it stopped: Enrollment difficulty

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01196845
Sponsor's protocol ID
09-CHUG-25
Other IDs
2009-A00826-51
Acronym
ADISAS
Status last verified
Dec 2025
First submitted
6 Sep 2010
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 16304292

  • 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.

    PubMed 14532320

  • 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.

    PubMed 17395738

  • 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.

    PubMed 15781100

  • 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.

    PubMed 17251237

  • 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.

    PubMed 12586529

  • 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.

    PubMed 26567858

Questions about this trial

What is this clinical trial studying?

A study testing cPAP in people with Decrease of Inflammation of Adipose Tissue and Sleep Apnea Syndrome, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Enrollment difficulty). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease of inflammation in adipose tissue (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01196845, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in