Condition category
Circulatory System
Date applied
20/02/2009
Date assigned
20/04/2009
Last edited
11/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dundee.ac.uk

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

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23994420

Publication citations

Additional files

Editorial Notes

11/07/2016: Publication reference added.