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
Parallel
tributyrin
Drug500 mg oral tributyrin twice daily for 12 weeks
Placebo
Other interventionStandard therapy alone
Glycemic parameters
Fasting plasma glucose (FPG), HbA1c
lipid profile
LDL-C, HDL-C, triglycerides
Inflammatory markers
CRP, IL-6, TNF-α
oxidative stress markers
MDA, total antioxidant capacity
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This trial is not recruiting at the moment. You can still explore other options:
