Do xanthine oxidase inhibitors regress left ventricular hypertrophy in diabetes? A whole new approach to reducing cardiac deaths
| ISRCTN | ISRCTN96755104 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96755104 |
| Clinical Trials Information System (CTIS) | 2008-008485-12 |
| Protocol serial number | eb/lm/let390/ln950/20038 |
| Sponsor | University of Dundee (UK) |
| Funder | Diabetes UK (UK) (ref: BDA:RD08/0003627) |
- Submission date
- 20/02/2009
- Registration date
- 20/04/2009
- Last edited
- 11/07/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Allan Struthers
Scientific
Scientific
Clinical Pharmacology and Therapeutics
University of Dundee
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
| Phone | +44 (0)1382 632180 |
|---|---|
| a.d.struthers@dundee.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre double-blind randomised placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Do xanthine oxidase inhibitors regress left ventricular hypertrophy in diabetes? A double-blind randomised placebo-controlled trial |
| Study objectives | The primary aim is to see if allopurinol (a xanthine oxidase inhibitor) reduces left ventricular hypertrophy over and above normotensive type 2 diabetics. |
| Ethics approval(s) | Fife and Forth Valley Research Ethics Committee pending approval as of 20/02/2009, ref: 09/S)501/3 |
| Health condition(s) or problem(s) studied | Left ventricular hypertrophy |
| Intervention | Allpurinol or placebo will be given in a stepwise manner as shown below: 1. 100 mg/placebo once daily (od) for 2 weeks 2. 300 mg/placebo od for 2 weeks 3. 600 mg/placebo od for 1 year Allopurinol and placebo will be given orally. Contact details for patient information sheet: Ben Szwejkowski Clinical Research Fellow Department of Clinical Pharmacology University of Dundee Ninewells Hospital and Medical School Dundee DD1 9SY United Kingdom |
| Intervention type | Drug |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Allopurinol |
| Primary outcome measure(s) |
To assess if allopurinol reduces left ventricular hypertrophy in patients with diabetes |
| Key secondary outcome measure(s) |
1. To assess if allopurinol improves endothelial function in diabetic patients will be done with flow mediated dilatation (FMD) and sphygmocor measurements. These tests will be done at time 0, 6 months and 1 year. |
| Completion date | 01/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 66 |
| Key inclusion criteria | 1. Patients with type 2 diabetes 2. Patients with left ventricular hypertrophy 3. Office target blood pressure less than 150/90 mmHg at recruitment No age or gender restrictions. |
| Key exclusion criteria | 1. Gout 2. Already on allopurinol 3. Previous adverse reaction to allopurinol 4. Poor kidney function (estimated glomerular filtration rate [eGFR] less than 60 ml/mm) 5. Conditions that exclude magnetic resonance imaging (MRI) 6. Heart failure (left ventricular ejection fraction [LVEF] less than 45%) 7. Cancer or other life threatening illness 8. Pregnancy or breast feeding 9. Unable to provide consent |
| Date of first enrolment | 02/02/2009 |
| Date of final enrolment | 01/02/2011 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
DD1 9SY
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 | 17/12/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/07/2016: Publication reference added.
