Aspirin Resistance and Sleep Apnea in Type-2 Diabetic Patients (AREAS)
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|ClinicalTrials.gov Identifier: NCT01788930|
Recruitment Status : Recruiting
First Posted : February 11, 2013
Last Update Posted : September 29, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Atherothrombosis Type 2 Diabetes Obstructive Sleep Apnea Syndrome||Device: CPAP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||286 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Obstructive Sleep Apnea and Aspirin Resistance in Type-2 Diabetic Patients|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||October 2017|
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
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.
- Response to antiplatelet therapy [ Time Frame: Measure will be done in the morning after the sleep diagnosis ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01788930
|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|
|Grenoble University Hospital||Recruiting|
|Grenoble, Isere, France|
|Contact: Marie PEETERS +334 76 76 92 65 MPeeters@chu-grenoble.fr|
|Principal Investigator: Olivier ORMEZZANO, MD, PhD|
|Sub-Investigator: Jean-Louis PEPIN, MD, PhD|
|Sub-Investigator: Patrick LEVY, MD, PhD|
|Sub-Investigator: Renaud TAMISIER, MD, PhD|
|Sub-Investigator: Sandrine LAUNOIS, MD, PhD|
|Sub-Investigator: Pierre-Yves BENHAMOU, MD, PhD|
|Sub-Investigator: Anne-Laure BOREL, MD, PhD|
|Sub-Investigator: Nelly WION-BARBOT, MD, PhD|
|Sub-Investigator: Patrice FAURE, MD, PhD|
|Sub-Investigator: Françoise STANKE, MD, PhD|
|Sub-Investigator: Jean-Philippe BAGUET, MD, PhD|
|Sub-Investigator: Gérald VANZETTO, MD, PhD|
|Sub-Investigator: Patrick CARPENTIER, MD, PhD|
|Sub-Investigator: Christophe SEINTURIER, MD, PhD|
|Sub-Investigator: Jacqueline YVER, MD, PhD|
|Sub-Investigator: Gilles PERNOD, MD, PhD|
|Sub-Investigator: Benoit POLACK, MD, PhD|
|Sub-Investigator: Raphael MARLU, MD, PhD|
|Sub-Investigator: Cécile BOSC, MD|
|Sub-Investigator: Marie DESTORS, MD|
|Principal Investigator:||Olivier ORMEZZANO, MD, PhD||University Hospital, Grenoble|