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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
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atherothrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 7, 2013
Last Updated
October 9, 2018
Sponsor
University Hospital, Grenoble
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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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