Elucidating the Effects of Tocotrienol rich Vitamin E on Metabolic Biomarkers in a Pre-diabetes Population of different ethnicities in Malaysia.

Monash University Malaysia0 个研究点目标入组 240 人开始时间: 2022年2月11日最近更新: 2022年2月21日

适应症

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•1.Multi-ethnic population in Malaysia namely, Chinese, Malay, Indian and Orang Asli (indigenous population) who are 40 years and above with high risk of Diabetes Mellitus/Pre-diabetes with a FINDRISC Score of 15 and above i.e. risk of diabetes 33%. (Follow the FINDRISC Model)
•A risk score of 15 to 20 points indicates a high risk of diabetes (33% chance of diabetes over 10 years).
•A risk score of greater than 20 points indicate a very high risk of diabetes (50% chance of diabetes over 10 years).
•2.Pre-Diabetes criteria: HbA1c: 6.0 to 6.5%.
•3.Newly diagnosed diabetes patients ( less than 5 years) with HbA1c equal to 8% and on 2 medications or less and excluding insulin.

•1.FINDRISC score lower than 15 and HbA1c greater than 6.5% for pre diabetes, and greater than 8.0% for new diabetes
•2.Diagnosed diabetes patients for 5 years or more.
•3.Fluctuating blood sugar level
•unstable glucose control (more than 10% change in HbA1c levels over the last 2 months)
•4.High blood pressure
•poor blood pressure control, BP greater than 160/100
•5.Pregnancy
•pregnant during screening
•6.Breastfeeding mothers
•7.Known diabetic or non-diabetic kidney disease, such as kidney stones etc.
•8.Acute or severe chronic illness such as acute coronary syndrome, active tuberculosis, and previous or current history of cancer, liver, or inflammatory disease etc.
•9.Taking other vitamins such as Vitamin C or A for the past 1 month
•10.Taking other water-soluble antioxidants for the past 2 weeks or fat-soluble antioxidants for the past 1 month
•11.Abnormal liver enzyme
•elevated liver enzymes (serum ALT and/or serum AST more than 3 times the upper limit of normal)
•12.Participants that are below 40 years old and above 75 years old.

发起方

Monash University Malaysia