Not Yet RecruitingNot Applicable

Butyrate or Intensive Lifestyle Modification in Type 1 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease

Spain200 participantsStarted 2026-09-15

Plain-language summary

Background: Metabolic dysfunction-associated steatotic liver disease (MASLD) is highly prevalent in individuals with type 1 diabetes (T1D) and is associated with increased cardiovascular and metabolic risk. However, evidence regarding effective therapeutic strategies for MASLD in T1D remains scarce. Lifestyle modification has shown benefits in obesity and type 2 diabetes, whereas butyrate, a microbiota-derived short-chain fatty acid, has emerged as a potential therapeutic approach because of its anti-inflammatory and metabolic effects. This study aims to evaluate the efficacy of intensive lifestyle modification, butyrate supplementation, or their combination on hepatic steatosis in individuals with T1D and MASLD. Methods: BEAM-T1D is a factorial, randomized, 6-month, parallel-group, placebo-controlled clinical trial conducted at the Regional University Hospital of Malaga. A total of 200 adults with T1D and MASLD will be randomized (1:1:1:1) to receive: (1) standard lifestyle recommendations plus placebo; (2) intensive lifestyle modification plus placebo; (3) standard lifestyle recommendations plus butyrate; or (4) intensive lifestyle modification plus butyrate. Intensive lifestyle modification includes a hypocaloric Mediterranean diet and promotion of physical activity. Participants randomized to butyrate will receive 2.25 g/day of microencapsulated sodium butyrate. The primary endpoint will be the change in controlled attenuation parameter (CAP) measured by transient elastography (FibroScan®). Secondary outcomes include changes in liver fat content, insulin resistance, metabolic control, body composition, inflammatory markers, gut microbiota composition, and short-chain fatty acid concentrations. Results: Participant recruitment is expected to begin in October 2025. The study will evaluate the independent and combined effects of butyrate supplementation and intensive lifestyle modification on hepatic steatosis and metabolic outcomes in individuals with T1D and MASLD. Conclusion: The BEAM-T1D study will provide novel evidence regarding the potential role of butyrate and intensive lifestyle modification in the management of MASLD in T1D. If effective, these interventions could represent feasible and scalable therapeutic strategies for a population with limited evidence-based treatment options.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is looking at butyrate supplements and lifestyle changes for people who have both Type 1 diabetes and a fatty liver condition — does my situation actually fit what they're studying, and is my liver health something we should be paying closer attention to?
2The trial hasn't started enrolling yet — given where I am right now with my health, does it make more sense to wait and see if I might qualify for this study, or should we be pursuing treatment options for my liver right away?
3The study is measuring liver fat and stiffness using a FibroScan — is that something you'd recommend I get done regardless of this trial, so we have a baseline picture of what's happening with my liver?
4This trial compares butyrate supplements to intensive lifestyle changes — from what you know about both approaches, are there any safety concerns specific to someone with Type 1 diabetes that I should weigh before considering either of these?
5Since this trial has no assigned phase, which suggests it may be early or exploratory in nature, what is currently the most evidence-based way to manage fatty liver disease in someone with Type 1 diabetes, and how does that compare to what this study is testing?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in Controlled Attenuation Parameter (CAP) by hepatic elastography (FibroScan®): Controlled Attenuation Parameter (CAP)

Timeframe: Baseline, 3 month and 6 month

Changes in Controlled Attenuation Parameter (CAP) by hepatic elastography (FibroScan®): Liver Stiffness Measurement

Timeframe: Baseline, 3 month and 6 month

Trial details

NCT IDNCT07684248

SponsorFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-15

Contact for this trial

Jose Carlos Fernández García, MD

951290343 josec.fernandez.garcia.sspa@juntadeandalucia.es

View on ClinicalTrials.gov More Type 1 Diabetes trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Changes in Controlled Attenuation Parameter (CAP) by hepatic elastography (FibroScan®): Controlled Attenuation Parameter (CAP)

Timeframe: Baseline, 3 month and 6 month

Changes in Controlled Attenuation Parameter (CAP) by hepatic elastography (FibroScan®): Liver Stiffness Measurement

Timeframe: Baseline, 3 month and 6 month