Reversal of cerebrovascular endothelial dysfunction in diabetes: the effect of allopurinol upon cerebrovascular nitric oxide bioavailability
| ISRCTN | ISRCTN68849312 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68849312 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/09/2005
- Registration date
- 22/11/2005
- Last edited
- 05/01/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Matthew Walters
Scientific
Scientific
Department of Medicine & Therapeutics
Western Infirmary
44 Church Street
Glasgow
G11 6NT
United Kingdom
| Phone | +44 (0)141 211 2821 |
|---|---|
| gcl203@clinmed.gla.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study hypothesis | Treatment with a xanthine oxidase inhibitor will improve cerebrovascular reactivity in patients with diabetes. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Diabetes |
| Intervention | Two weeks allopurinol versus lactose capsule. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Allopurinol |
| Primary outcome measure | 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 study start date | 01/11/2005 |
| Overall study end date | 01/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 24 |
| 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 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
- Scotland
- United Kingdom
Study participating centre
Department of Medicine & Therapeutics
Glasgow
G11 6NT
United Kingdom
G11 6NT
United Kingdom
Sponsor information
Greater Glasgow NHS Board/Glasgow University (UK)
Not defined
Not defined
c/o Judith Godden
Administration Building
Western Infirmary
Dumbarton Road
Glasgow
G11 6NT
United Kingdom
| Phone | +44 (0)141 211 2000 |
|---|---|
| judith.godden@Northglasgow.NHS.Scot.UK | |
"ROR" |
https://ror.org/05kdz4d87 |
Funders
Funder type
Government
Chief Scientist Office of the Scottish Executive Health Department (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2009 | Yes | No |
