Clinical trial NCT01788930: Aspirin Resistance and Sleep Apnea in Type-2 Diabetic Patients
Official title: Obstructive Sleep Apnea and Aspirin Resistance in Type-2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atherothrombosis
Type 2 Diabetes
Obstructive Sleep Apnea Syndrome
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2013-02-11
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Response to antiplatelet therapy
timeFrame: Measure will be done in the morning after the sleep diagnosis
Secondary outcomes:
measure: Effects of CPAP treatment for severe obstructive sleep apnea on aspirin efficacity in type-2 diabetic patients
timeFrame: Change from baseline after 3 months randomized treatment
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble University Hospital
state: Isere
Study officials:
affiliation: University Hospital, Grenoble
name: Olivier ORMEZZANO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: