Contact information
Type
Scientific
Primary contact
Prof Allan Struthers
ORCID ID
Contact details
Clinical Pharmacology and Therapeutics
University of Dundee
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 632180
a.d.struthers@dundee.ac.uk
Additional identifiers
EudraCT number
2008-008485-12
ClinicalTrials.gov number
Protocol/serial number
eb/lm/let390/ln950/20038
Study information
Scientific title
Do xanthine oxidase inhibitors regress left ventricular hypertrophy in diabetes? A double-blind randomised placebo-controlled trial
Acronym
Study hypothesis
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
Fife and Forth Valley Research Ethics Committee pending approval as of 20/02/2009, ref: 09/S)501/3
Study design
Single-centre double-blind randomised placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details provided in the interventions field to request a patient information sheet
Condition
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 names
Allopurinol
Primary outcome measure
To assess if allopurinol reduces left ventricular hypertrophy in patients with diabetes
Secondary outcome measures
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.
2. To assess if allopurinol reduces arrthymogenicity in diabetic patients will be done with a technique called microvolt T wave alternans (MTWA). This test will be done at time 0 and 1 year.
Overall trial start date
02/02/2009
Overall trial end date
01/02/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
66
Participant 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
Recruitment start date
02/02/2009
Recruitment end date
01/02/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
Sponsor information
Organisation
University of Dundee (UK)
Sponsor details
Research and Innovation Services
Dundee
DD1 4HN
United Kingdom
+44 (0)1382 384664
j.z.houston@dundee.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Diabetes UK (UK) (ref: BDA:RD08/0003627)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23994420