Role of antioxidant therapy in preventing diabetic kidney disease
| ISRCTN | ISRCTN97358113 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97358113 |
| Secondary identifying numbers | 05/Q0803/57 |
- Submission date
- 13/11/2007
- Registration date
- 29/01/2009
- Last edited
- 26/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
St. George's Hospital NHS Trust
St. George's Hospital Medical School
Thomas Addison Diabetes Centre
Lanesborough Wing
London
SW17 0QT
United Kingdom
Study information
| Study design | Randomised double-blind controlled study |
|---|---|
| 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 below to request a patient information sheet |
| Scientific title | Role of antioxidant therapy in preventing diabetic kidney disease: a randomised, double-blind controlled study |
| Study objectives | 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(s) | Wandsworth Local Research Ethics Committee, St George's Hospital, 01/08/2005, ref: 05/Q0803/57 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2006 |
| Completion date | 27/07/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 400 |
| Key inclusion criteria | 1. Adult ambulant patients with type two diabetes 2. Ability to give written informed consent |
| Key exclusion criteria | 1. History of cardiovascular disease 2. Evidence of severe renal impairment 3. Pregnancy 4. Malignancy |
| Date of first enrolment | 10/10/2011 |
| Date of final enrolment | 29/04/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SW17 0RE
United Kingdom
Sponsor information
University/education
St George's Research Office
Cranmer Terrace
Tooting
London
SW17 0RE
England
United Kingdom
| Website | http://www.sgul.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/040f08y74 |
Funders
Funder type
Charity
No information available
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 04/08/2016 | Yes | No | |
| Preprint results | results in preprint | 19/02/2019 | No | No |
Editorial Notes
26/10/2020: Preprint reference added.
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.
