Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/09/2005
Date assigned
22/11/2005
Last edited
05/01/2009
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 Matthew Walters

ORCID ID

Contact details

Department of Medicine & Therapeutics
Western Infirmary
44 Church Street
Glasgow
G11 6NT
United Kingdom
+44 (0)141 211 2821
gcl203@clinmed.gla.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Treatment with a xanthine oxidase inhibitor will improve cerebrovascular reactivity in patients with diabetes.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Diabetes

Intervention

Two weeks allopurinol versus lactose capsule.

Intervention type

Drug

Phase

Not Applicable

Drug names

Allopurinol

Primary outcome measures

The change in internal carotid artery flow following L-NMMA infusion.

Secondary outcome measures

1. Change in serum urate level
2. Change in middle cerebral artery flow velocity

Overall trial start date

01/11/2005

Overall trial end date

01/11/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Type II diabetes less than 5 years duration, treated with diet, metformin thiazolidinediones or a combination
2. Aged greater than 40 years
3. Normal full Bruce protocol exercise treadmill testing (ETT)
4. Favourable temporal bony window
5. HbA1c less than 9%
6. Cholesterol less than 7.5 mmol/l

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant exclusion criteria

1. Greater than 70% Internal carotid artery stenosis
2. Known coronary artery disease
3. Other significant comorbidity
4. Contraindication to allopurinol
5. Concurrent therapy with azathioprine or 6-mercaptopurine
6. Insulin or sulphonylurea treatment
7. Serum creatinine greater than 250 µmol/l

Recruitment start date

01/11/2005

Recruitment end date

01/11/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Medicine & Therapeutics
Glasgow
G11 6NT
United Kingdom

Sponsor information

Organisation

Greater Glasgow NHS Board/Glasgow University (UK)

Sponsor details

c/o Judith Godden
Administration Building
Western Infirmary
Dumbarton Road
Glasgow
G11 6NT
United Kingdom
+44 (0)141 211 2000
judith.godden@Northglasgow.NHS.Scot.UK

Sponsor type

Not defined

Website

Funders

Funder type

Government

Funder name

Chief Scientist Office of the Scottish Executive Health Department (UK)

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18945924

Publication citations

  1. Results

    Dawson J, Quinn T, Harrow C, Lees KR, Weir CJ, Cleland SJ, Walters MR, Allopurinol and nitric oxide activity in the cerebral circulation of those with diabetes: a randomized trial., Diabetes Care, 2009, 32, 1, 135-137, doi: 10.2337/dc08-1179.

Additional files

Editorial Notes