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

NCT07503548 | Not Yet Recruiting Phase 3

• 1 other identifier: HM000216
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabete Mellitus

Keywords

Tributyrin; Diabetes mellitus; glycemic control; insulin resistance

Outcome Measures

Primary Outcomes (1)

• Glycemic parameters

  Fasting plasma glucose (FPG), HbA1c

  week 12

Secondary Outcomes (3)

• lipid profile

  week 12

• Inflammatory markers

  week 12

• oxidative stress markers

  week 12

Study Arms (2)

Tributyrin

EXPERIMENTAL

500 mg oral tributyrin twice daily for 12 weeks

Drug: tributyrin

Placebo

OTHER

Standard therapy alone

Other: Placebo

Interventions

tributyrin DRUG

500 mg oral tributyrin twice daily for 12 weeks

Tributyrin

Placebo OTHER

Standard therapy alone

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Matareya Teaching Hospital

Cairo, Egypt

Location

Related Publications (1)

• Ragheb SR, El Wakeel LM, Nasr MS, Sabri NA. Impact of Rutin and Vitamin C combination on oxidative stress and glycemic control in patients with type 2 diabetes. Clin Nutr ESPEN. 2020 Feb;35:128-135. doi: 10.1016/j.clnesp.2019.10.015. Epub 2019 Nov 14.

  PMID: 31987106 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance

Interventions

tributyrin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Central Study Contacts

Amira Younes, MD

CONTACT

+201146916564; amira.younes@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pharmacy Practice and Clinical Pharmacy

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: March 31, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): August 26, 2026
• Study Completion (Estimated): August 26, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)