Aspirin Resistance and Sleep Apnea in Type-2 Diabetic Pat... | NCT01788930

Studies
Aspirin Resistance and Sleep Apnea in Type-2 Diabetic Patients

NCT01788930

Sponsor

University Hospital, Grenoble

Status

Terminated

Last Update Posted

Oct 12, 2018Actual

Enrollment

53Actual

Phase

Not Applicable

Conditions

Atherothrombosis
Type 2 Diabetes
Obstructive Sleep Apnea Syndrome

Interventions

CPAP

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recommendations changing

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Jul 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

Feb 7, 2013

First Submission Date that Met QC Criteria

Feb 7, 2013

First Posted Date

Feb 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2018

Last Update Posted Date

Oct 12, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CPAP	Device		CPAP Sham-CPAP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response to antiplatelet therapy		Measure will be done in the morning after the sleep diagnosis

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olivier ORMEZZANO, MD, PhD	University Hospital, Grenoble	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Grenoble University Hospital		Grenoble	Isere		France

Condition Browse Module

MeSH Terms

ID	Term
D013927	Thrombosis
D003924	Diabetes Mellitus, Type 2
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D003920	Diabetes Mellitus

Browse Leaves

Not provided

Browse Branches

Not provided