Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR305; P03-154
Study information
Scientific title
Acronym
DIASP study
Study hypothesis
An early intervention with low-dose aspirin in asymptomatic diabetic subjects attenuates progression of atherosclerosis, by decreasing inflammation and coagulation.
Ethics approval
Received from local medical ethics committee
Study design
Randomised double-blind placebo controlled crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Aspirin
Primary outcome measures
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 trial start date
27/04/2005
Overall trial end date
31/03/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
27/04/2005
Recruitment end date
31/03/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
Leiden University Medical Centre (LUMC) (Netherlands)
Sponsor details
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Leiden University Medical Centre (LUMC) (Netherlands) - Department of General Internal Medicine
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2007 results on http://www.ncbi.nlm.nih.gov/pubmed/17456193
2. 2008 results on http://www.ncbi.nlm.nih.gov/pubmed/18034847
Publication citations
-
Results
Hovens MM, Snoep JD, Groeneveld Y, Tamsma JT, Eikenboom JC, Huisman MV, High levels of low-density lipoprotein cholesterol and triglycerides and suboptimal glycemic control predict diminished ex vivo aspirin responsiveness in patients with Type 2 diabetes., J. Thromb. Haemost., 2007, 5, 7, 1562-1564, doi: 10.1111/j.1538-7836.2007.02596.x.
-
Results
Hovens MM, Snoep JD, Groeneveld Y, Frölich M, Tamsma JT, Huisman MV, Effects of aspirin on serum C-reactive protein and interleukin-6 levels in patients with type 2 diabetes without cardiovascular disease: a randomized placebo-controlled crossover trial., Diabetes Obes Metab, 2008, 10, 8, 668-674, doi: 10.1111/j.1463-1326.2007.00794.x.