Type 2 Diabetes Clinical Trial
— AREASOfficial title:
Obstructive Sleep Apnea and Aspirin Resistance in Type-2 Diabetic Patients
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 |
Verified date | October 2018 |
Source | University Hospital, Grenoble |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Grenoble University Hospital | Grenoble | Isere |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble |
France,
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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