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
- Diseases
- Type 2 diabetes
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Matareya Teaching Hospital Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.