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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 because the information has not been verified recently.
Verified February 2009 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00649909
First received: March 27, 2008
Last updated: February 8, 2009
Last verified: February 2009
History of Changes
  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:

MedlinePlus related topics: Diabetes
Drug Information available for: Aspirin
U.S. FDA Resources

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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]

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

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00649909

Contacts
Contact: Arik Tzukert, DMD 972 2 6776095 arik@hadassah.org.il
Contact: Hadas Lemberg, PhD 972 2 6777572 lhadas@hadassah.org.il

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

No publications provided

Responsible Party: Prof. David Varon, Hematology department, head 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: February 8, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by 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
Pharmacologic Actions
 Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013