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

NCT ID: NCT00649909

Last Updated: 2017-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type II

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observation

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

No interventions assigned to this group

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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David Varon

Director of coagulation unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Varon, MD

Role: PRINCIPAL_INVESTIGATOR

Hematology Department, Hadassah Medical Organization, Jerusalem, Israel

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0020-08-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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