Role of antioxidant therapy in preventing diabetic kidney disease

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN97358113

Enrollment

400

Registered

2009-01-29

Start date

2011-10-10

Completion date

Unknown

Last updated

2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

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 intak

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026