Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
03/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marcel M.C. Hovens

ORCID ID

Contact details

Leiden University Medical Center
Department of General Internal Medicine
P.O. Box 9600
Leiden
2300 RC
Netherlands

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 (NSAID’s)
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

http://www.lumc.nl/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes