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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
Sponsor:
Information provided by (Responsible Party):
David Varon, Hadassah Medical Organization

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Diabetes Mellitus, Type II

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Observation
Type 2 diabetic patients with reduced laboratory response to aspirin.(Aspirin Resistance)and with HbA1c >8%.


Outcome Measures
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Primary Outcome Measures :
  1. The outcome measure is the laboratory Aspirin Resistance. [ Time Frame: 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. [ Time Frame: On screening visit. ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 2 diabetic patients that take aspirin, from the diabetology clinic.
Criteria

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: David Varon, MD Hematology Department, Hadassah Medical Organization, Jerusalem, Israel
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: David Varon, Director of coagulation unit, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00649909     History of Changes
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

Keywords provided by David Varon, Hadassah Medical Organization:
Diabetes Mellitus
Type II
Aspirin
Resistance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics