Diabetes Mellitus, Type II Clinical Trial
Official title:
Effect of Glucose Control on the Response to Aspirin in Type 2 Diabetic Patients
Verified date | August 2017 |
Source | Hadassah Medical Organization |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Israel | Hadassah Medical Organization | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Hadassah Medical Organization |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The outcome measure is the laboratory Aspirin Resistance. | 3 and 6 months. | ||
Secondary | 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. |
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