Aspirin Resistance and Sleep Apnea (AREAS)
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Purpose
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)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 | Intervention |
|---|---|
|
Atherothrombosis Type 2 Diabetes Obstructive Sleep Apnea Syndrome |
Device: CPAP |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Diagnostic |
| Official Title: | Obstructive Sleep Apnea and Aspirin Resistance in Type-2 Diabetic Patients |
- Response to antiplatelet therapy [ Time Frame: Measure will be done in the morning after the sleep diagnosis ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 286 |
| Study Start Date: | February 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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.
|
Device: CPAP |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- 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
Contacts and Locations| 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 | |
| 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 | |
| Principal Investigator: | Olivier ORMEZZANO, MD, PhD | University Hospital, Grenoble |
More Information
No publications provided
| Responsible Party: | University Hospital, Grenoble |
| ClinicalTrials.gov Identifier: | NCT01788930 History of Changes |
| Other Study ID Numbers: | 1227 |
| Study First Received: | February 7, 2013 |
| Last Updated: | February 7, 2013 |
| Health Authority: | France: 'French National Agency for Drug Safety' |
Additional relevant MeSH terms:
|
Apnea Diabetes Mellitus, Type 2 Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013