Effects of aspirin on markers of inflammation and coagulation in subclinical atherosclerosis in type 2 diabetic subjects

Completed

Conditions: Diabetes mellitus type 2 (DM type 2)
Nutritional, Metabolic, Endocrine
Non-insulin dependant diabetes

Registration Number: ISRCTN84139732

Lead Sponsor: eiden University Medical Centre (LUMC) (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

1. Diabetes mellitus type 2
2. Aged greater than 18 years
3. HbA1c less than 10%
4. High sensitivity C-reactive protein (hsCRP) greater than 1.0 mg/l

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 ischaemic attack
3. History of peripheral vascular disease, ankle/arm index less than 10, 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 non-steroidal anti-inflammatory drugs (NSAID?s)
14. Use of any anti-thrombotic medication
15. Use of corticosteriods
16. Use of HMG-CoA-reductase inhibitors

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Markers of vascular wall inflammation, represented by hsCRP and IL-6

Secondary Outcome Measures

Name	Time	Method
1. Prostaglandin production, represented by 11-dehydro-thromboxaneB2, 8-isoprostaglandineF2a and 2,3-dinor-6-keto-prostaglandineF1a measured in morning urine samples<br>2. Vascular wall adhesion molecules, represented by sICAM-1, p-selectin, MCSF, CD40L<br>3. Coagulation markers, represented by fibrinogen, vWillebrand Factor and PAI-1 activity