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

Monash University Malaysia0 sites116 target enrollmentNovember 13, 2019

Overview

No summary available.

Registry

who.int

Start Date

November 13, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Monash University Malaysia

•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

•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