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

NCT07503548 · tracked via the Priya Life Science Egypt tracker

Sponsor

Ain Shams University

Phase

Phase 3

Started

2026-03-26

Last updated

2026-03-31

Condition(s) studied

Diabete Mellitus

Investigational drug(s) / intervention(s)

tributyrinPlacebo

tributyrin: 500 mg oral tributyrin twice daily for 12 weeks

Placebo: Standard therapy alone

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: * • Diagnosed with Type 2 DM for ≥ 1 year * ASCVD 10-year risk ≥ 7.5% * Stable antidiabetic and cardiovascular medication regimen for ≥ 3 months * Able to provide informed consent and comply with study procedures Exclusion Criteria: * • Established cardiovascular disease (history of MI, stroke, or revascularization) * Chronic gastrointestinal disorders affecting absorption * Severe hepatic or renal impairment * Use of GLP-1 receptor agonists or SGLT2 inhibitors * Pregnancy or lactation * Known hypersensitivity to tributyrin or butyrate

Primary outcome measure(s)

Glycemic parameters — week 12
Fasting plasma glucose (FPG), HbA1c

Trial sites (1)

Facility	City	Region	Status
Matareya Teaching Hospital	Cairo	Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07503548 on ClinicalTrials.gov ↗ ← All trials in Egypt