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
EudraCT/CTIS number	2008-008485-12
Secondary identifying numbers	eb/lm/let390/ln950/20038

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

Clinical Pharmacology and Therapeutics
University of Dundee
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

Phone	+44 (0)1382 632180
Email	a.d.struthers@dundee.ac.uk

Study information

Study design	Single-centre double-blind randomised placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details provided in the interventions field to request a patient 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
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	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 study start date	02/02/2009
Completion date	01/02/2011

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	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

Scotland
United Kingdom

Study participating centre

Ninewells Hospital and Medical School

Dundee
DD1 9SY
United Kingdom

Sponsor information

University of Dundee (UK)
University/education

Research and Innovation Services
Dundee
DD1 4HN
Scotland
United Kingdom

Phone	+44 (0)1382 384664
Email	j.z.houston@dundee.ac.uk
Website	http://www.dundee.ac.uk
"ROR"	https://ror.org/03h2bxq36

Funders

Funder type

Charity

Diabetes UK (UK) (ref: BDA:RD08/0003627)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): DIABETES UK LIMITED, British Diabetic Association
Location: United Kingdom

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	17/12/2013		Yes	No

Editorial Notes

11/07/2016: Publication reference added.