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
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
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