Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/11/2007
Date assigned
29/01/2009
Last edited
29/06/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of this study is to investigate the role of antioxidants (vitamin E and/or selenium) in the prevention of kidney disease in patients with type 2 diabetes.

Who can participate?
Adult patients with type 2 diabetes

What does the study involve?
Participants are randomly allocated to take either vitamin E or placebo (dummy supplement) and to take either selenium or placebo. The method of intake is oral and the duration of intake is 3 years. Kidney function is assessed every 6 months.

What are the possible benefits and risks of participating?
All patients could potentially benefit from having their general health reviewed more frequently than is the case with their usual care. Those patients receiving active treatment may benefit from preservation of their kidney function in the longer term. There is a possibility that by having more regular interactions with the research team than usual new health problems might be uncovered. Should this happen there will be appropriate further investigation and/or treatment which may or may not affect the participant's ability to continue in the study.

Where is the study run from?
St George's University of London (UK)

When is the study starting and how long is it expected to run for?
March 2006 to July 2016

Who is funding the study?
St George's Hospital NHS Trust Charitable Trust Foundation (UK)

Who is the main contact?
Dr Kenneth Earle

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kenneth Earle

ORCID ID

Contact details

St. George’s Hospital NHS Trust
St. George’s Hospital Medical School
Thomas Addison Diabetes Centre
Lanesborough Wing
London
SW17 0QT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

05/Q0803/57

Study information

Scientific title

Role of antioxidant therapy in preventing diabetic kidney disease: a randomised, double-blind controlled study

Acronym

Study hypothesis

Susceptibility to kidney disease failure in patients with diabetes is associated with reduction in kidney blood flow due to a chemical imbalance called oxidative stress. Therefore, the supplementation of antioxidants may reverse it.

Ethics approval

Wandsworth Local Research Ethics Committee, St George's Hospital, 01/08/2005, ref: 05/Q0803/57

Study design

Randomised double-blind controlled study

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 below to request a patient information sheet

Condition

Type 2 diabetes

Intervention

Two month washout period, then patients will be randomised to receive vitamin E 400 IU daily or placebo and 200 µg daily selenium or placebo. The method of intake is oral and the duration of the intake is 3 years.

Intervention type

Supplement

Phase

Not Applicable

Drug names

Antioxidant supplementation

Primary outcome measure

1. Change in renal blood flow
2. Change in serum creatinine and creatinine clearance
Assessments every 6 months

Secondary outcome measures

1. Systolic blood pressure
2. Diastolic blood pressure
3. Total cholesterol
4. Total triglycerides
5. Beta-2 microglobulin
6. Haemoglobin A1c
7. F2-alpha isoprostanes
8. Monocyte vascular endothelial growth factor (VEGF) production
9. Total antioxidant capacity
10. Urine monocyte chemoattractant protein-1 (MCP-1)
11. Urine albumin:creatinine ratio
Assessments every 6 months

Overall trial start date

01/03/2006

Overall trial end date

27/07/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adult ambulant patients with type two diabetes
2. Ability to give written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. History of cardiovascular disease
2. Evidence of severe renal impairment
3. Pregnancy
4. Malignancy

Recruitment start date

10/10/2011

Recruitment end date

29/04/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St George's University of London
London
SW17 0RE
United Kingdom

Sponsor information

Organisation

St George's University of London

Sponsor details

St George's Research Office
Cranmer Terrace
Tooting
London
SW17 0RE
United Kingdom

Sponsor type

University/education

Website

http://www.sgul.ac.uk/

Funders

Funder type

Charity

Funder name

St George's Hospital NHS Trust Charitable Trust Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27492324

Publication citations

Additional files

Editorial Notes

29/06/2018: The following changes were made to the trial record: 1. The sponsor was changed from St George's Hospital NHS Trust to St George's University of London. 2. The recruitment dates were added. 3. The overall trial end date was changed from 28/02/2015 to 27/07/2016. 4. The plain English summary was added. 08/08/2016: Publication reference added. 23/12/2010: This record has been updated to include an extended overall trial end date due to delays with the setup of the study. The previous overall trial end date was 31/05/2010.