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
-
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.