Aspirin Resistance and Sleep Apnea in Type-2 Diabetic Patients

NCT ID: NCT01788930

Last Updated: 2018-10-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2017-10-31

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.

Conditions

Atherothrombosis; Type 2 Diabetes; Obstructive Sleep Apnea Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

CPAP

Intervention Type: DEVICE

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.

Group Type: PLACEBO_COMPARATOR

CPAP

Intervention Type: DEVICE

Interventions

CPAP

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier ORMEZZANO, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

Grenoble University Hospital

Grenoble, Isere, France

Countries

France

Other Identifiers

1227

Identifier Type: -

Identifier Source: org_study_id