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Effect of Glucose Control on the Response to Aspirin in Type 2 Diabetic Patients

Sponsor
Hadassah Medical Organization (Other)
Overall Status
Completed
CT.gov ID
NCT00649909
Collaborator
(none)
18
Enrollment
1
Location
24
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The efficacy of low dose aspirin appears to be substantially lower in diabetic patients, compared to patients without diabetes.

We will perform an observational study where we follow up patients with uncontrolled type 2 Diabetes Mellitus and low response to aspirin (Aspirin Resistance), during a period of 6 months in the diabetic clinic. Our hypothesis is that glucose control will improve the response to aspirin in those patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    18 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effect of Glucose Control on the Response to Aspirin in Type 2 Diabetic Patients
    Study Start Date :
    Nov 1, 2008
    Actual Primary Completion Date :
    Nov 1, 2010
    Actual Study Completion Date :
    Nov 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Observation

    Type 2 diabetic patients with reduced laboratory response to aspirin.(Aspirin Resistance)and with HbA1c >8%.

    Outcome Measures

    Primary Outcome Measures

    1. The outcome measure is the laboratory Aspirin Resistance. [3 and 6 months.]

    Secondary Outcome Measures

    1. To determine the incidence of laboratory aspirin resistance in type 2 DM in stable out-patients in the diabetic clinic, and possibly related factors. [On screening visit.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    1. Type 2 DM.

    2. Patients that take aspirin.

    3. Antecubital forearm veins allowing technically good sampling for platelet studies.

    4. Reduced Laboratory response to aspirin.

    5. HbA1c > 8 %

    6. The physician decides that there is an indication for glucose control.

    Exclusion Criteria:

    1. Acute ischemic stroke, acute coronary syndrome, (myocardial infarction or unstable angina pectoris), or revascularization by PCI or by-pass surgery within the last 6 months.

    2. Acute kidney disease or chronic kidney disease with creatinine clearance <30.

    3. Acute liver disease or chronic liver disease with severe liver impairment.

    4. Need for treatment with anticoagulants, clopidogrel, NSAID's, or thiazolidinediones.

    5. Thrombocytopenia (platelet count <150 x 109/L)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hadassah Medical Organization Jerusalem Israel

    Sponsors and Collaborators

    • Hadassah Medical Organization

    Investigators

    • Principal Investigator: David Varon, MD, Hematology Department, Hadassah Medical Organization, Jerusalem, Israel

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David Varon, Director of coagulation unit, Hadassah Medical Organization
    ClinicalTrials.gov Identifier:
    NCT00649909
    Other Study ID Numbers:
    • 0020-08-HMO-CTIL
    First Posted:
    Apr 1, 2008
    Last Update Posted:
    Aug 10, 2017
    Last Verified:
    Aug 1, 2017
    Keywords provided by David Varon, Director of coagulation unit, Hadassah Medical Organization
    Diabetes Mellitus
    Type II
    Aspirin
    Resistance
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Aug 10, 2017