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

August 9, 2017 updated by: David Varon, Hadassah Medical Organization

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 2 diabetic patients that take aspirin, from the diabetology clinic.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The outcome measure is the laboratory Aspirin Resistance.
Time Frame: 3 and 6 months.
3 and 6 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
On screening visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: David Varon, MD, Hematology Department, Hadassah Medical Organization, Jerusalem, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

March 27, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 1, 2008

Study Record Updates

Last Update Posted (Actual)

August 10, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0020-08-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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