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
Recruitment status was Recruiting
Sponsor:
Hadassah Medical Organization
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00649909
First received: March 27, 2008
Last updated: February 8, 2009
Last verified: February 2009
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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 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| Ages Eligible for Study: | Child, Adult, Senior |
| 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00649909
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
| 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 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 September 28, 2016