Role of Tocotrienol supplementation on carotid intima media thickness in patients with Type 2 Diabetes Mellitus patients

Effect of Tocotrienol supplementation on carotid intima media thickness in patients with Type 2 Diabetes Mellitus â?? An Open label, Randomized-controlled clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/054548

Enrollment

Registered

2023-06-28

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Tocotrienol supplementation: Tocotrienol 200mg once daily after meals for period of 12 weeks Control Intervention1: Standard treatment: Standard treatment

Eligibility

Inclusion criteria

Inclusion criteria: • T2DM patients who have not achieved target HbA1c on any antidiabetic drugs for atleast 3 months , with HbA1c ranging between (6.5-10%). • Willing to participate by giving written informed consent.

Exclusion criteria

Exclusion criteria: 1. Not willing to provide consent 2. Pregnant and lactating women 3. Hospitalisation for recent infection in last 2 weeks 4. eGFR 5. Current use of Vitamin E supplementation, Vitamin E allergy 6. Current or past smokers 7. Malignancies 8. Rheumatological conditions namely (Autoimmune diseases, vasculitis, connective tissue disorders) 9. Resistant HTN( >140/90 on 3 antihypertensive medications) 10. Acute/chronic liver diseases

Design outcomes

Primary

Measure	Time frame
CHANGE IN CAROTID INTIMA MEDIA THICKNESSTimepoint: OVER A PERIOD OF 12 WEEKS	—

Secondary

Measure	Time frame
To evaluate change in LDL,HDL,TGL, Total Cholesterol over a period of 12 weeks To evaluate the change in HbA1C over a period of 12 weeksTimepoint: 12 WEEKS	—

Countries

India

Contacts

Public ContactDR DHRITI SUNDAR DAS

AIIMS BHUBANESWAR

genmed_dhriti@aiimsbhubaneswar.edu.in8011605711

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026