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 |
| Protocol serial number | N/A |
| Sponsor | Greater Glasgow NHS Board/Glasgow University (UK) |
| Funder | Chief Scientist Office of the Scottish Executive Health Department (UK) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Treatment with a xanthine oxidase inhibitor will improve cerebrovascular reactivity in patients with diabetes. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Diabetes |
| Intervention | Two weeks allopurinol versus lactose capsule. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Allopurinol |
| Primary outcome measure(s) |
The change in internal carotid artery flow following L-NMMA infusion. |
| Key secondary outcome measure(s) |
1. Change in serum urate level |
| Completion date | 01/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 24 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 01/11/2006 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Department of Medicine & Therapeutics
Glasgow
G11 6NT
United Kingdom
G11 6NT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
