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

Diabetes Mellitus, Type II Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00649909
• Other study ID #: 0020-08-HMO-CTIL
• Status: Completed
• Phase: N/A
• First received: March 27, 2008
• Last updated: August 9, 2017
• Start date: November 2008
• Est. completion date: November 2010

Study information

• Verified date: August 2017
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The outcome measure is the laboratory Aspirin Resistance.		3 and 6 months.
Secondary	To determine the incidence of laboratory aspirin resistance in type 2 DM in stable out-patients in the diabetic clinic, and possibly related factors.		On screening visit.