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Could a gut bacteria byproduct help tame fatty liver in type 1 diabetes?

NCT ID NCT07684248

Disease control Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This trial investigates whether a supplement called butyrate (a substance produced by gut bacteria) and an intensive lifestyle program (Mediterranean diet plus exercise) can reduce liver fat in adults with type 1 diabetes who also have fatty liver disease. Participants are randomly assigned to one of four groups: standard advice plus placebo, lifestyle changes plus placebo, butyrate alone, or both butyrate and lifestyle changes. The study measures changes in liver fat using a special ultrasound-like scan, along with blood sugar control and other health markers over six months.

What this could mean

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

Active substance
sodium butyrate (microencapsulated)
What this could lead to
If effective, this could offer a simple, low-cost way to manage fatty liver disease in people with type 1 diabetes, where few treatment options exist.
What could go wrong
This is a mid-sized early-stage trial, and the benefits seen may not be large or lasting. Butyrate supplements can cause mild digestive upset.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

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 75 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: * Age 18-75 years. * Type 1 diabetes. * MASLD: Defined by a Controlled Attenuation Parameter (CAP) measured by Fibroscan® ≥248 dB/m (40). * Signed informed consent. Exclusion Criteria: * History of alcohol consumption \> 50 g/day in men or \> 30 g/day in women for 3 consecutive months in the last year. * Patients with impaired liver function (total bilirubin \> 2.0 mg/dL). * Hemochromatosis, Wilson's disease, or autoimmune hepatitis. * History of cancer (except basal cell carcinoma) in the past 5 years or active cancer of any type. * Known infection with HIV, HBV, HCV, or any other infection that may cause liver disease. * Severe underlying diseases that, in the investigators' judgment, constitute an exclusion criterion for study participation. * Reduced life expectancy. * Pregnant or breastfeeding women. * Documented history of intolerance/allergy to butyrate. * Participation in another clinical trial within 30 days prior to study entry. * Inability to comply with scheduled visits. * Use of antibiotics, prebiotics, or probiotics (in pharmacological form or as supplements, not as part of usual diet) in the month prior to inclusion in the study.

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatotic liver disease type 1 diabetes mellitus

As listed by the trial registrant

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

Type 1 diabetes

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

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Contacts and locations

Locations

  • Hospital Regional Universitario de Málaga, FIMABIS

    Málaga, Málaga, 29009, Spain

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