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NOT YET RECRUITING
NCT07503548
PHASE3

Effect of Tributyrin Supplementation on Glycemic Control, Inflammation, and Cardiovascular Risk in Patients With Type 2 Diabetes

Sponsor: Ain Shams University

View on ClinicalTrials.gov

Summary

This study evaluates the effectiveness and safety of tributyrin supplementation in patients with type 2 diabetes mellitus (T2DM) who are at increased risk of cardiovascular disease. Type 2 diabetes is commonly associated with poor blood sugar control, chronic inflammation, oxidative stress, and an increased risk of heart disease. Tributyrin is a dietary supplement that acts as a precursor to butyrate, a compound known for its anti-inflammatory and metabolic benefits. It may help improve blood sugar levels, reduce inflammation, and lower cardiovascular risk. In this randomized, double-blind, controlled clinical trial, participants will receive either tributyrin in addition to their standard diabetes treatment or standard therapy alone. The study will assess whether tributyrin improves glycemic control, inflammation, oxidative stress, lipid profile, and overall cardiovascular risk while maintaining safety and tolerability.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-03-26

Completion Date

2026-08-26

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DRUG

tributyrin

500 mg oral tributyrin twice daily for 12 weeks

OTHER

Placebo

Standard therapy alone

Locations (1)

Matareya Teaching Hospital

Cairo, Egypt