Type 2 Diabetes Mellitus
Conditions
Keywords
NIDDM, Aspirin, platelet inhibition, Aspirin treatment
Brief summary
The efficacy of low dose aspirin appears to be substantially lower in diabetic patients, compared to patients without diabetes. The aim of the investigators study is to test the laboratory response to different dosing of aspirin in type 2 Diabetes Mellitus. The investigators will compare the regular dose of 75mg once daily to 75 mg twice daily or to 320 mg once daily. The hypothesis of the study is that twice daily dosing of aspirin may improve the response to aspirin.
Interventions
DRUGAspirin
75 mg per day versus 75 mg twice daily and 320mg once daily
DRUGaspirin
crossover study with three dosages: 75 mg once daily, 75 mg twice daily, 320 mg once daily.
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 DM with micro- or macroangiopathy. * HbA1c 6-9 % (Mono-S method). * Need for, or already on-going aspirin treatment. * Age 50-75 years * Antecubital forearm veins allowing technically good sampling for platelet studies
Exclusion criteria
* Diet controlled DM. * 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 or chronic kidney disease (P-cystatin C within the reference interval) * Acute or chronic liver disease (ALAT ≤2 times the upper reference value). * A history of gastric or duodenal ulcer disease. * Need for treatment with anticoagulants, clopidogrel, NSAID's, or thiazolidinediones. * Thrombocytopenia (platelet count \<150 x 109/L) * Anticipated need for alteration of concomitant drug therapy during the course of the study. * Enrollment in another clinical study. * Contraindication(s) to aspirin treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An exploratory study with three co-primary response variables which are directly related to platelet COX-1 inhibition: arachidonic acid-induced platelet aggregation in whole blood and PRP and in the Cone-and-Plate(let) Assay (CPA) | 12 or 24 hours after last dose of Aspirin |
Secondary
| Measure | Time frame |
|---|---|
| Indirectly COX-related platelet aggregation induced by collagen or ADP, and thromboxane metabolite excretion. | 12 or 24 hours after last dose of aspirin |
Countries
Sweden
Outcome results
None listed