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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00649909

First Posted: April 1, 2008

Last Update Posted: August 10, 2017

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.

Information provided by (Responsible Party):

David Varon, Hadassah Medical Organization

Purpose

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
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:

Drug Information available for: Aspirin

U.S. FDA Resources

Further study details as provided by David Varon, 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. ]


Enrollment:	18
Study Start Date:	November 2008
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

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

Eligibility

Information from the National Library of Medicine

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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

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)

Contacts and Locations

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


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 Submitted:	March 27, 2008
First Posted:	April 1, 2008
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

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