Effects of aspirin on markers of inflammation and coagulation in subclinical atherosclerosis in type 2 diabetic subjects
| ISRCTN | ISRCTN84139732 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84139732 |
| Secondary identifying numbers | NTR305; P03-154 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 03/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Marcel M.C. Hovens
Scientific
Scientific
Leiden University Medical Center
Department of General Internal Medicine
P.O. Box 9600
Leiden
2300 RC
Netherlands
Study information
| Study design | Randomised double-blind placebo controlled crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | DIASP study |
| Study objectives | An early intervention with low-dose aspirin in asymptomatic diabetic subjects attenuates progression of atherosclerosis, by decreasing inflammation and coagulation. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Diabetes mellitus type 2 (DM type 2) |
| 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Aspirin |
| Primary outcome measure | Markers of vascular wall inflammation, represented by hsCRP and IL-6 |
| Secondary outcome measures | 1. Prostaglandin production, represented by 11-dehydro-thromboxaneB2, 8-isoprostaglandineF2a and 2,3-dinor-6-keto-prostaglandineF1a 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 |
| Overall study start date | 27/04/2005 |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 (NSAIDs) 14. Use of any anti-thrombotic medication 15. Use of corticosteriods 16. Use of HMG-CoA-reductase inhibitors |
| Date of first enrolment | 27/04/2005 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (Netherlands)
University/education
University/education
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/ |
|---|---|
"ROR" |
https://ror.org/027bh9e22 |
Funders
Funder type
Hospital/treatment centre
Leiden University Medical Centre (LUMC) (Netherlands) - Department of General Internal Medicine
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2007 | Yes | No | |
| Results article | results | 01/08/2008 | Yes | No |
