Diabetes Mellitus type 2, no cardiovascular disease.
Conditions
Interventions
Subjects will be randomised between aspirin 100 mg and 300 mg. During the study period, each group will be followed 16 weeks. Treatment with aspirin (100 or 300 mg) or placebo for 6 weeks will be foll
Sponsors
Leiden University Medical Center (LUMC), department of General Internal Medicine
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diabetes mellitus type 2; 2. Age >18 year; 3. HbA1c 1.0 mg/l .
Exclusion criteria
Exclusion criteria: 1. History of myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, proven manifest coronary artery disease, angina pectoris, heart failure or severe cardiac arrhythmia; 2. History of cerebrovascular accident, transient ischemic attack; 3. History of peripheral vascular disease, ankle/arm index < 1.0, history of partial ileal bypass surgery; 4. Uncontrolled hypertension; 5. Asthma; 6. Any bleeding disorder; 7. History of gastrointestinal tract bleeding; 8. Severe renal or hepatic dysfunction; 9. Pregnancy; 10. Recent participation in other research projects; 11. Recent blood donation; 12. Known allergy to salicylic acid; 13. Use of all NSAID’s; 14. Use of any antithrombotic medication; 15. Use of corticosteriods; 16. Use of HMG-CoA-reductaseinhibitors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Markers of vascular wall inflammation, represented by hsCRP and Il-6. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Prostaglandin production, represented by 11-dehydro-thromboxaneB2, 8-isoprostaglandineF2á and 2,3-dinor-6-keto-prostaglandineF1á measured in morning-urine samples; 2. Vascular wall adhesion molecules, represented by sICAM-1, p-selectin, MCSF, CD40L; 3. Coagulation markers, represented by fibrinogen, vWillebrand Factor and PAI-1 activity. | — |
Contacts
Public ContactMarcel M.C. Hovens
Leiden University Medical Center (LUMC), Department of General Internal Medicine, P.O. Box 9600
Outcome results
None listed