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NCT07503548Not yet recruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 31 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
60 (estimated)
First submitted
26 Mar 2026
Start date
26 Mar 2026
Primary completion date
26 Aug 2026
Lead sponsor
Ain Shams University
NCT number
NCT07503548

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 60
  • From 26 Mar 2026 to the primary completion date, 26 Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • • 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

Who the study is looking for

  • • 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

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Matareya Teaching Hospital
Coordinator of this site? Confirm its status
CairoEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.