Aspirin Resistance and Sleep Apnea in Type-2 Diabetic Patients (AREAS)
Primary Purpose
Atherothrombosis, Type 2 Diabetes, Obstructive Sleep Apnea Syndrome
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CPAP
Sponsored by
About this trial
This is an interventional diagnostic trial for Atherothrombosis
Eligibility Criteria
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
Sites / Locations
- Grenoble University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
CPAP
Sham-CPAP
Arm Description
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
This device consists in a sham CPAP. It will be applied 3 months after the beginning of drug treatment and for 3 months.
Outcomes
Primary Outcome Measures
Response to antiplatelet therapy
Secondary Outcome Measures
Effects of CPAP treatment for severe obstructive sleep apnea on aspirin efficacity in type-2 diabetic patients
Full Information
NCT ID
NCT01788930
First Posted
February 7, 2013
Last Updated
October 9, 2018
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT01788930
Brief Title
Aspirin Resistance and Sleep Apnea in Type-2 Diabetic Patients
Acronym
AREAS
Official Title
Obstructive Sleep Apnea and Aspirin Resistance in Type-2 Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Recommendations changing
Study Start Date
February 2013 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherothrombosis, Type 2 Diabetes, Obstructive Sleep Apnea Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPAP
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sham-CPAP
Arm Type
Placebo Comparator
Arm Description
This device consists in a sham CPAP. It will be applied 3 months after the beginning of drug treatment and for 3 months.
Intervention Type
Device
Intervention Name(s)
CPAP
Primary Outcome Measure Information:
Title
Response to antiplatelet therapy
Time Frame
Measure will be done in the morning after the sleep diagnosis
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier ORMEZZANO, MD, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grenoble University Hospital
City
Grenoble
State/Province
Isere
Country
France
12. IPD Sharing Statement
Learn more about this trial
Aspirin Resistance and Sleep Apnea in Type-2 Diabetic Patients
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