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

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Diabete Mellitus

In brief

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 facts

Study ID

NCT07503548

Run by

Ain Shams University

People needed

60

Starts

2026-03-26

Expected to finish

2026-08-26

Last updated by the study team

2026-03-31

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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

You may not qualify if…

• • 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

Where it is running

• Matareya Teaching Hospital — Cairo, Egypt

Full record on ClinicalTrials.gov

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