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Aspirin Resistance and Sleep Apnea in Type-2 Diabetic Patients (AREAS)

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ClinicalTrials.gov Identifier: NCT01788930
Recruitment Status : Recruiting
First Posted : February 11, 2013
Last Update Posted : September 29, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Atherothrombosis Type 2 Diabetes Obstructive Sleep Apnea Syndrome Device: CPAP

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Obstructive Sleep Apnea and Aspirin Resistance in Type-2 Diabetic Patients
Study Start Date : February 2013
Primary Completion Date : July 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Aspirin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 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

Device: CPAP
Placebo Comparator: 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.
Device: CPAP

Outcome Measures

Primary Outcome Measures :
  1. Response to antiplatelet therapy [ Time Frame: Measure will be done in the morning after the sleep diagnosis ]

Secondary Outcome Measures :
  1. Effects of CPAP treatment for severe obstructive sleep apnea on aspirin efficacity in type-2 diabetic patients [ Time Frame: Change from baseline after 3 months randomized treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01788930

Contact: Olivier ORMEZZANO, MD, PhD +33 4 76 76 75 75 OOrmezzano@chu-grenoble.fr
Contact: Jean-Louis PEPIN, MD, PhD + 33 4 76 76 55 16 JPepin@chu-grenoble.fr

Grenoble University Hospital Recruiting
Grenoble, Isere, France
Contact: Marie PEETERS    +334 76 76 92 65    MPeeters@chu-grenoble.fr   
Principal Investigator: Olivier ORMEZZANO, MD, PhD         
Sub-Investigator: Jean-Louis PEPIN, MD, PhD         
Sub-Investigator: Patrick LEVY, MD, PhD         
Sub-Investigator: Renaud TAMISIER, MD, PhD         
Sub-Investigator: Sandrine LAUNOIS, MD, PhD         
Sub-Investigator: Pierre-Yves BENHAMOU, MD, PhD         
Sub-Investigator: Anne-Laure BOREL, MD, PhD         
Sub-Investigator: Nelly WION-BARBOT, MD, PhD         
Sub-Investigator: Patrice FAURE, MD, PhD         
Sub-Investigator: Françoise STANKE, MD, PhD         
Sub-Investigator: Jean-Philippe BAGUET, MD, PhD         
Sub-Investigator: Gérald VANZETTO, MD, PhD         
Sub-Investigator: Patrick CARPENTIER, MD, PhD         
Sub-Investigator: Christophe SEINTURIER, MD, PhD         
Sub-Investigator: Jacqueline YVER, MD, PhD         
Sub-Investigator: Gilles PERNOD, MD, PhD         
Sub-Investigator: Benoit POLACK, MD, PhD         
Sub-Investigator: Raphael MARLU, MD, PhD         
Sub-Investigator: Cécile BOSC, MD         
Sub-Investigator: Marie DESTORS, MD         
Sponsors and Collaborators
University Hospital, Grenoble
Principal Investigator: Olivier ORMEZZANO, MD, PhD University Hospital, Grenoble
More Information

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01788930     History of Changes
Other Study ID Numbers: 1227
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors