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

Phase 2

Not yet recruiting

• Conditions: Prediabetes; Impaired fasting glucose; Impaired Glucose Tolerance; Newly diagnosed diabetes; Metabolic and Endocrine - Diabetes; Metabolic and Endocrine - Metabolic disorders

• Registration Number: ACTRN12622000256774
• Lead Sponsor: Monash University Malaysia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-11
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified