Diabete MellitusPhase 3NCT07503548
Effect of Tributyrin Supplementation on Glycemic Control, Inflammation, and Cardiovascular Risk in Patients With Type 2 Diabetes
A Phase 3 study testing tributyrin in people with Diabete Mellitus, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabete Mellitus
- What is being tested?
- tributyrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Mar 2026to 26 Aug 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Matareya Teaching Hospital
Cairo
Amira Younes, MD, +201146916564, amira.younes@gmail.com
About this study
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.
Read the 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.
- Conditions
- Diabete Mellitus
- Being tested
- tributyrin, Placebo
- Keywords
- Tributyrin, Diabetes mellitus, glycemic control, insulin resistance
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tributyrinDrug
500 mg oral tributyrin twice daily for 12 weeks
PlaceboOther
Standard therapy alone
| Study group | Role | What they receive |
|---|---|---|
| Tributyrin | Experimental | 500 mg oral tributyrin twice daily for 12 weeks Receives: Drug: tributyrin |
| Placebo | Other | Standard therapy alone Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic parameters
Fasting plasma glucose (FPG), HbA1c
Measured: week 12
Secondary outcomes (3)
lipid profile
LDL-C, HDL-C, triglycerides
Measured: week 12
Inflammatory markers
CRP, IL-6, TNF-α
Measured: week 12
oxidative stress markers
MDA, total antioxidant capacity
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start26 Mar 2026 (estimated)
- Primary completion26 Aug 2026 (estimated)
- Study completion26 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohamed El Mokadem, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503548
- Sponsor's protocol ID
- HM000216
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31987106
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tributyrin Supplementation on Glycemic Control, Inflammation, and Cardiovascular Risk in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07503548
- Acronym / sponsor ID
- HM000216
- Conditions
- Diabete Mellitus
- Keywords
- Tributyrin, Diabetes mellitus, glycemic control, insulin resistance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 26 Mar 2026 (estimated)
- Primary completion
- 26 Aug 2026 (estimated)
- Study completion
- 26 Aug 2026 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tributyrin | Experimental | Drug: tributyrin500 mg oral tributyrin twice daily for 12 weeks |
| Placebo | Other | Other: PlaceboStandard therapy alone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Diagnosed with Type 2 DM for ≥ 1 year
Key exclusion criteria (6 listed)
- • Established cardiovascular disease (history of MI, stroke, or revascularization)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tributyrin500 mg oral tributyrin twice daily for 12 weeks | Drug | Tributyrin |
| PlaceboStandard therapy alone | Other | Placebo |
Primary outcome
Glycemic parameters
Time frame: week 12
Fasting plasma glucose (FPG), HbA1c
3 secondary outcomes
lipid profile
Time frame: week 12
Inflammatory markers
Time frame: week 12
oxidative stress markers
Time frame: week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Background: PubMed 31987106Ragheb 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tributyrin in people with Diabete Mellitus, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amira Younes, MD (+201146916564, amira.younes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic parameters (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07503548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.