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

Hadassah Medical Organization18 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diabetes Mellitus, Type II

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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)

Locations (1)

Hadassah Medical Organization

Jerusalem, Israel

Outcomes

Primary Outcomes

The outcome measure is the laboratory Aspirin Resistance.

Time frame: 3 and 6 months.

Secondary Outcomes

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

Time frame: On screening visit.

Data from ClinicalTrials.gov

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