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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Varon, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00649909
First received: March 27, 2008
Last updated: August 9, 2017
Last verified: August 2017
  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:


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

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
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 ClinicalTrials.gov identifier: 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
Study First Received: March 27, 2008
Last Updated: August 9, 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

ClinicalTrials.gov processed this record on August 18, 2017