NCT01788930

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

4.4 years

First QC Date

February 7, 2013

Last Update Submit

October 9, 2018

Conditions

AtherothrombosisType 2 DiabetesObstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (1)

  • Response to antiplatelet therapy

    Measure will be done in the morning after the sleep diagnosis

Secondary Outcomes (1)

  • 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

Study Arms (2)

CPAP

ACTIVE COMPARATOR

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

Device: CPAP

Sham-CPAP

PLACEBO COMPARATOR

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

Device: CPAP

Interventions

CPAPDEVICE
CPAPSham-CPAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grenoble University Hospital

Grenoble, Isere, France

Location

MeSH Terms

Conditions

ThrombosisDiabetes Mellitus, Type 2Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Olivier ORMEZZANO, MD, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2013

First Posted

February 11, 2013

Study Start

February 1, 2013

Primary Completion

July 1, 2017

Study Completion

October 1, 2017

Last Updated

October 12, 2018

Record last verified: 2018-10

Locations

FR(1)