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Could a simple supplement tame diabetes and heart risk?

NCT ID NCT07503548

Disease control Sponsor: Ain Shams University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether tributyrin, a dietary supplement that turns into butyrate in the body, can improve blood sugar control, reduce inflammation, and lower heart disease risk in people with type 2 diabetes. Sixty participants at high risk for heart problems will receive either tributyrin or a placebo alongside their usual diabetes treatment for 12 weeks. The goal is to see if this safe, natural compound can offer extra benefits beyond standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tributyrin (a dietary supplement that turns into butyrate in the body)
What this could lead to
If it works, this could point toward a simple, safe supplement to help manage blood sugar and reduce heart disease risk in people with type 2 diabetes.
What could go wrong
This is a small, early-phase trial with only 60 participants, so results may not apply to everyone. The supplement may not show significant benefits over standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Insulin Resistance type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabete mellitus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Matareya Teaching Hospital

    Cairo, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.