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

March 26, 2026 updated by: Eman Mohamed El Mokadem, Ain Shams University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by hyperglycemia, insulin resistance, and progressive beta-cell dysfunction. It is strongly associated with chronic low-grade inflammation, oxidative stress, endothelial dysfunction, and an increased risk of atherosclerotic cardiovascular disease (ASCVD).

Short-chain fatty acids, particularly butyrate, have been shown to exert beneficial metabolic effects, including improving insulin sensitivity, reducing inflammation, and modulating oxidative stress. However, the clinical use of butyrate is limited by its poor bioavailability. Tributyrin, a triglyceride form of butyrate, serves as a prodrug that enhances absorption and provides sustained systemic release of butyrate.

Emerging evidence suggests that tributyrin may improve glycemic control, reduce inflammatory cytokines such as C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α), enhance lipid metabolism, and improve endothelial function. Despite these promising findings, there is a lack of well-designed clinical trials evaluating its role in patients with T2DM, particularly those at elevated cardiovascular risk.

This study is a prospective, randomized, double-blind, controlled clinical trial conducted in adult patients with T2DM attending a diabetic outpatient clinic. Eligible participants will be randomly assigned in a 1:1 ratio to receive either oral tributyrin (500 mg twice daily) in addition to standard therapy or standard therapy alone for 12 weeks. Blinding will be maintained using identical capsules.

The primary objective is to evaluate the effect of tributyrin on glycemic control, assessed by fasting plasma glucose and glycated hemoglobin (HbA1c). Secondary objectives include assessment of inflammatory markers (CRP, IL-6, TNF-α), oxidative stress parameters (malondialdehyde and total antioxidant capacity), lipid profile (LDL-C, HDL-C, triglycerides), and estimated cardiovascular risk.

Safety outcomes will include monitoring of liver and renal function and the incidence of adverse events. Participants will be followed at regular intervals to assess treatment adherence, tolerability, and clinical response.

This study aims to determine whether tributyrin can serve as a safe and effective adjunctive therapy to improve metabolic control and reduce cardiovascular risk in patients with type 2 diabetes.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • 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

Exclusion Criteria:

  • • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tributyrin
500 mg oral tributyrin twice daily for 12 weeks
Drug: tributyrin
500 mg oral tributyrin twice daily for 12 weeks
Other: Placebo
Standard therapy alone
Other: Placebo
Standard therapy alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic parameters
Time Frame: week 12
Fasting plasma glucose (FPG), HbA1c
week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lipid profile
Time Frame: week 12
LDL-C, HDL-C, triglycerides
week 12
Inflammatory markers
Time Frame: week 12
CRP, IL-6, TNF-α
week 12
oxidative stress markers
Time Frame: week 12
MDA, total antioxidant capacity
week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 26, 2026

Primary Completion (Estimated)

August 26, 2026

Study Completion (Estimated)

August 26, 2026

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM000216

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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