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Aspirin Resistance and Sleep Apnea in Type-2 Diabetic Patients (AREAS)

This study is currently recruiting participants.
Verified September 2017 by University Hospital, Grenoble
Sponsor:
ClinicalTrials.gov Identifier:
NCT01788930
First Posted: February 11, 2013
Last Update Posted: September 29, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Grenoble
February 7, 2013
February 11, 2013
September 29, 2017
February 2013
July 2017   (Final data collection date for primary outcome measure)
Response to antiplatelet therapy [ Time Frame: Measure will be done in the morning after the sleep diagnosis ]
Same as current
Complete list of historical versions of study NCT01788930 on ClinicalTrials.gov Archive Site
Effects of CPAP treatment for severe obstructive sleep apnea on aspirin efficacity in type-2 diabetic patients [ Time Frame: Change from baseline after 3 months randomized treatment ]
Same as current
Not Provided
Not Provided
 
Aspirin Resistance and Sleep Apnea in Type-2 Diabetic Patients
Obstructive Sleep Apnea and Aspirin Resistance in Type-2 Diabetic Patients

Type-2 Diabetes and Sleep Apnea Syndrome (SAS) are both related to an increase in platelet activation. Type 2 diabetes is often associated with sleep apnea syndrome with a prevalence up to 60%.

The main objective of our study is to analyze the influence of sleep apnea on the response to antiplatelet therapy in stable aspirin-treated type-2 diabetes patients.

Consecutive stable aspirin-treated type-2 diabetes patients referred for suspicion of sleep apnea will be recruited after providing informed consent. Response to aspirin will be assessed with the Verify Now Aspirin(TM)rapid analyser in the morning after nocturnal polysomnography, and compared with a group of type-2 diabetes free of sleep apnea. Other endocrine, metabolic, hematologic and cardiovascular confounders will also be assessed at baseline to determine their influence on the response to aspirin.

Then, Patients with severe SAS (Apnea-Hypopnea Index> 30 events/h) and response with Aspirin (ARU > 454) will be randomized to 3 months of active or sham continuous positive airway pressure treatment in a pilot study. After the 3-months of intervention, response to aspirin will be compared between the sham and effective CPAP groups.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
  • Atherothrombosis
  • Type 2 Diabetes
  • Obstructive Sleep Apnea Syndrome
Device: CPAP
  • Active Comparator: CPAP

    This device consists in a nasal continuous positive airway pressure (CPAP). It will be applied 3 months after the beginning of drug treatment and for 3 months.

    Other Name: positive airway pressure

    Intervention: Device: CPAP
  • Placebo Comparator: Sham-CPAP
    This device consists in a sham CPAP. It will be applied 3 months after the beginning of drug treatment and for 3 months.
    Intervention: Device: CPAP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
286
October 2017
July 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women aged > 18 years old
  • With Type 2 diabetes
  • Stable Atherothrombosis for more than 3 months
  • Using aspirin for more than 10 days or without aspirin (in this last case, they will do only the observational study.)
  • Without any modification in their treatments for 10 days
  • Ambulatory patient
  • Without any cardiovascular event or inflammatory disease for 3 months before inclusion

Exclusion Criteria:

  • Pregnant women
  • Other active clinically significant illness, including unstable cardiovascular, or neoplasia which could interfere with the study conduct or counterindicate the study treatments or place the patient at risk during the trial or compromise the study participation
  • Patients participating in an other study
  • Patient without any medical care insurance
  • Any treatment that could interfere with aspirin
  • Previous treatment by CPAP
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Olivier ORMEZZANO, MD, PhD +33 4 76 76 75 75 OOrmezzano@chu-grenoble.fr
Contact: Jean-Louis PEPIN, MD, PhD + 33 4 76 76 55 16 JPepin@chu-grenoble.fr
France
 
 
NCT01788930
1227
Yes
Not Provided
Not Provided
University Hospital, Grenoble
University Hospital, Grenoble
Not Provided
Principal Investigator: Olivier ORMEZZANO, MD, PhD University Hospital, Grenoble
University Hospital, Grenoble
September 2017

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