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

The overarching aim of the research is to establish the potential mechanisms of action(s) of Vitamin E on diabetes and its diabetes microvascular complications, namely nephropathy, retinopathy and neuropathy. In this study, we aim to demonstrate the various mechanisms of actions(s) of Vitamin E; namely its anti-oxidant, anti-inflammatory, anti-thrombotic effects as well as establishing Vitamin E potential renal-, retinal- and/or neuro-protective role(s) by measuring its renal, retinal and nerve parameters respectively. We will also be measuring circulating levels of anti-oxidants and anti-inflammatory markers and determine any correlation with the severity of diabetes microvascular complications (i.e. nephropathy, retinopathy and neuropathy). We will also establish the levels of Vitamin E sub-types found both in extracellular fluid and erythrocytes. This is a prospective, randomized, double-blinded, placebo-controlled study. The study will take 12 months to complete. Patients (n=116) will be randomized into intervention and control groups. The interventional (INT) group will receive active treatment (200 mg Tocovid BD) and the control group will receive placebo (200 mg placebo BD) for 6 months. These patients will be followed up for 12 months and attend a total 8 visits. The detail timeline of the study will be provided in the relevant section below. The improvement of the microvascular complications will be assessed by (i) UACR & eGFR for renal parameters (ii) Intraretinal hemorrhages for retinal parameters and (iii) nerve conduction study for peripheral neuropathy. In addition, we will be measuring circulating inflammatory markers such as AGEs, MDA, TNFR1, VCAM-1, Thromboxane B2 and NGF in these patients.