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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00649909

Enrollment

Registered

2008-04-01

Start date

2008-11-30

Completion date

2010-11-30

Last updated

2017-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type II

Keywords

Diabetes Mellitus, Type II, Aspirin, Resistance

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
The outcome measure is the laboratory Aspirin Resistance.	3 and 6 months.

Secondary

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.	On screening visit.

Countries

Israel

Outcome results