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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00649909
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : August 10, 2017
Information provided by (Responsible Party):
David Varon, Hadassah Medical Organization

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

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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

Type 2 diabetic patients with reduced laboratory response to aspirin.(Aspirin Resistance)and with HbA1c >8%.

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. ]

Information from the National Library of Medicine

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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
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)

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 identifier (NCT number): NCT00649909

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Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: David Varon, MD Hematology Department, Hadassah Medical Organization, Jerusalem, Israel
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Responsible Party: David Varon, Director of coagulation unit, Hadassah Medical Organization 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
Keywords provided by David Varon, Hadassah Medical Organization:
Diabetes Mellitus
Type II
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases