No registrations found.
ID
Source
Brief title
Health condition
Diabetes Mellitus type 2, no cardiovascular disease.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Markers of vascular wall inflammation, represented by hsCRP and Il-6.
Secondary outcome
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.
Background summary
The DIASP study is a study with a prospective, randomised, placebo controlled, double blind, crossover study design, concerning the effects of aspirin (ASA) on markers of inflammation and coagulation in subclinical atherosclerosis in type 2 diabetic subjects. At random, forty patients will receive aspirin in low or intermediate dose in one period and placebo in the other period.
Study objective
An early intervention with low-dose aspirin in asymptomatic diabetic subjects attenuates progression of atherosclerosis, by decreasing inflammation and coagulation.
Study design
N/A
Intervention
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 followed by a washout period of 4 weeks. After the washout period, patients will be treated by placebo when they received aspirin during the first period, and aspirin when they received placebo.
P.O. Box 9600
Marcel M.C. Hovens
Leiden 2300 RC
The Netherlands
+31 (0)71 5262085
P.O. Box 9600
Marcel M.C. Hovens
Leiden 2300 RC
The Netherlands
+31 (0)71 5262085
Inclusion criteria
1. Diabetes mellitus type 2;
2. Age >18 year;
3. HbA1c < 10%;
4. HsCRP >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 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL267 |
| NTR-old | NTR305 |
| Other | : P03-154 |
| ISRCTN | ISRCTN84139732 |
Summary results
2. Diabetes Obes Metab. 2008 Aug;10(8):668-74. Epub 2007 Nov 22.