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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
Information provided by:
Hadassah Medical Organization Identifier:
First received: March 27, 2008
Last updated: February 8, 2009
Last verified: February 2009

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.

Diabetes Mellitus, Type II

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Glucose Control on the Response to Aspirin in Type 2 Diabetic Patients

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • The outcome measure is the laboratory Aspirin Resistance. [ Time Frame: 3 and 6 months. ]

Secondary Outcome Measures:
  • 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. ]

Estimated Enrollment: 30
Study Start Date: November 2008
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Type 2 diabetic patients with reduced laboratory response to aspirin.(Aspirin Resistance)and with HbA1c >8%.


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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00649909

Contact: Arik Tzukert, DMD 972 2 6776095
Contact: Hadas Lemberg, PhD 972 2 6777572

Hadassah Medical Organization Recruiting
Jerusalem, Israel
Principal Investigator: David Varon, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: David Varon, MD Hematology Department, Hadassah Medical Organization, Jerusalem, Israel
  More Information

Responsible Party: Prof. David Varon, Hematology department, head of Coagulation Unit., Hadassah Medical Organization. Identifier: NCT00649909     History of Changes
Other Study ID Numbers: 0020-08-HMO-CTIL
Study First Received: March 27, 2008
Last Updated: February 8, 2009

Keywords provided by Hadassah Medical Organization:
Diabetes Mellitus
Type II

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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 processed this record on April 27, 2017