Effect of Glucose Control on the Response to Aspirin in Type 2 Diabetic Patients
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ClinicalTrials.gov Identifier: NCT00649909 |
Recruitment Status :
Completed
First Posted : April 1, 2008
Last Update Posted : August 10, 2017
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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.
Condition or disease |
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Diabetes Mellitus, Type II |
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 : | November 2008 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | November 2010 |
Group/Cohort |
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Observation
Type 2 diabetic patients with reduced laboratory response to aspirin.(Aspirin Resistance)and with HbA1c >8%.
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- The outcome measure is the laboratory Aspirin Resistance. [ Time Frame: 3 and 6 months. ]
- 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. ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria
- Type 2 DM.
- Patients that take aspirin.
- Antecubital forearm veins allowing technically good sampling for platelet studies.
- Reduced Laboratory response to aspirin.
- HbA1c > 8 %
- The physician decides that there is an indication for glucose control.
Exclusion Criteria:
- 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.
- Acute kidney disease or chronic kidney disease with creatinine clearance <30.
- Acute liver disease or chronic liver disease with severe liver impairment.
- Need for treatment with anticoagulants, clopidogrel, NSAID's, or thiazolidinediones.
- Thrombocytopenia (platelet count <150 x 109/L)

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): NCT00649909
Israel | |
Hadassah Medical Organization | |
Jerusalem, Israel |
Principal Investigator: | David Varon, MD | Hematology Department, Hadassah Medical Organization, Jerusalem, Israel |
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: | April 1, 2008 Key Record Dates |
Last Update Posted: | August 10, 2017 |
Last Verified: | August 2017 |
Diabetes Mellitus Type II Aspirin Resistance |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |