Aspirin Resistance and Sleep Apnea in Type-2 Diabetic Patients

Not Applicable

Terminated

• Conditions: Obstructive Sleep Apnea Syndrome; Atherothrombosis; Type 2 Diabetes
• Interventions: Device: CPAP

• Registration Number: NCT01788930
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-07
• Study First Submitted QC: 2013-02-07
• Study First Posted: 2013-02-11
• Primary Completion: 2017-07
• Study Completion: 2017-10
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-09
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham-CPAP	CPAP	This device consists in a sham CPAP. It will be applied 3 months after the beginning of drug treatment and for 3 months.
CPAP	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

Primary Outcome Measures

Name	Time	Method
Response to antiplatelet therapy	Measure will be done in the morning after the sleep diagnosis

Secondary Outcome Measures

Name	Time	Method
Effects of CPAP treatment for severe obstructive sleep apnea on aspirin efficacity in type-2 diabetic patients	Change from baseline after 3 months randomized treatment

Trial Locations

Locations (1)

Grenoble University Hospital; 🇫🇷 Grenoble, Isere, France