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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01788930
Other study ID # 1227
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 2013
Est. completion date October 2017

Study information

Verified date October 2018
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 53
Est. completion date October 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Device:
CPAP


Locations

Country Name City State
France Grenoble University Hospital Grenoble Isere

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response to antiplatelet therapy Measure will be done in the morning after the sleep diagnosis
Secondary 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
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