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.
• 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
• 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
Ain Shams University
Lead sponsor