The Effects of Tocotrienol-Rich Vitamin E (Tocovid) on Diabetes and Diabetic Microvascular Complications: Kidney Disease (Nephropathy), Eye Disease (Retinopathy) and (Nerve Impariment (Neuropathy)

Phase 2

Recruiting

• Conditions: Diabetes Mellitus; Diabetic Nephropathy; Diabetic Retinopathy; Diabetic Neuropathy; Metabolic and Endocrine - Diabetes; Renal and Urogenital - Other renal and urogenital disorders; Eye - Diseases / disorders of the eye; Neurological - Other neurological disorders

• Registration Number: ACTRN12619001568101
• Lead Sponsor: Monash University Malaysia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-13
• Last Update Posted: 18 November 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

1. Subject, or legal representative, has voluntarily signed and dated an Informed Consent Form.
2. Subject is 35-75 years of age at screening date
3. Subject has T2DM with stable glucose control (not more than 10% change in HbA1c levels over the last 2 months) AND HbA1c range should be within 6-9%
4. Subject has eGFR of 30-89 AND has microalbuminuria as assessed by UACR of 20-200mg/mmol, or
5. Mild/moderate retinopathy as defined by: Mild: At least one microaneurysm Moderate: Hemorrhage/microaneurysm, cotton wool spots, venous beading, and intraretinal
microvascular abnormalities
6. If subject has hypertension, he/she must have stable blood pressure control for the past 2 months with not more than 10% change and BP range should be <145/90mmHg

Exclusion Criteria

1. Subject is pregnant during screening, OR planning to be pregnant, OR not on contraception
2. Subject has urine protein >1.5g/L during screening
3. Subject has current urinary tract infection during screening (symptomatic or definitively on urine FEME: pyuria, nitrites and red blood cells)
4. Subject has acute or severe chronic illness such as acute coronary syndrome, active tuberculosis, current history of cancer, liver or inflammatory disease etc.
5. Subject with unstable eye diseases such as media opacity and glaucoma
6. Subject has known non-diabetic kidney disease, such as kidney stones etc
7. Patient has severe chronic kidney disease (Stage 4/5 CKD, eGFR <30ml/min/1.73m2)
8. Subject is taking other water-soluble antioxidants for the past 2 weeks or fat-soluble antioxidants for the past 1 month
9. Subject is a heavy smoker (>20 sticks/day) that is currently smoking or has stopped smoking for <1 month

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine any changes in early diabetic nephropathy as assessed by microalbuminuria (urine albumin-creatinine ratio) in patients given tocotrienol-rich vitamin E from palm oil (Tocovid)[48 weeks];To determine any changes in early diabetic retinopathy as assessed by changes in intraretinal microhaemorrhage by means of fundal photography in patients given tocotrienol-rich vitamin E from palm oil (Tocovid)[48 weeks];To determine any changes in diabetic peripheral neuropathy as assessed by nerve conduction study in patients given tocotrienol-rich vitamin E from palm oil (Tocovid)[48 weeks]