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ISRCTN
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ISRCTN68849312
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ClinicalTrials.gov identifier
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Public title
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Reversal of cerebrovascular endothelial dysfunction in diabetes: the effect of allopurinol upon cerebrovascular nitric oxide bioavailability
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Treatment with a xanthine oxidase inhibitor will improve cerebrovascular reactivity in patients with diabetes.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Diabetes
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/11/2005
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Anticipated end date
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01/11/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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24
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Interventions
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Two weeks allopurinol versus lactose capsule.
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Primary outcome measure(s)
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The change in internal carotid artery flow following L-NMMA infusion.
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Secondary outcome measure(s)
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1. Change in serum urate level
2. Change in middle cerebral artery flow velocity
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Sources of funding
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Chief Scientist Office of the Scottish Executive Health Department (UK)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18945924
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Contact name
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Dr
Matthew
Walters
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Address
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Department of Medicine & Therapeutics
Western Infirmary
44 Church Street
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City/town
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Glasgow
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Zip/Postcode
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G11 6NT
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Country
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United Kingdom
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Tel
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+44 (0)141 211 2821
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Fax
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+44 (0)141 211 1863
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Email
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gcl203@clinmed.gla.ac.uk
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Sponsor
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Greater Glasgow NHS Board/Glasgow University (UK)
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Address
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c/o Judith Godden
Administration Building
Western Infirmary
Dumbarton Road
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City/town
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Glasgow
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Zip/Postcode
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G11 6NT
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Country
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United Kingdom
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Tel
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+44 (0)141 211 2000
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Email
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judith.godden@Northglasgow.NHS.Scot.UK
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Date applied
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09/09/2005
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Last edited
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05/01/2009
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Date ISRCTN assigned
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22/11/2005
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