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

NCT07684248 | Not Yet Recruiting

• 1 other identifier: BEAM-T1D Study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Keywords

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD); Short-Chain Fatty Acids (SCFAs); Sodium Butyrate; Type 1 Diabetes (T1D)

Outcome Measures

Primary Outcomes (2)

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

  Measured in dB/m

  Baseline, 3 month and 6 month

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

  Measured in : kPa

  Baseline, 3 month and 6 month

Secondary Outcomes (38)

• Changes in insulin resistance: eGDR

  Baseline, 3 months and 6 months

• Changes in metabolic control: Glucose

  Baseline, 3 months and 6 months

• Changes in metabolic control: HbA1c

  Baseline, 3 months and 6 months

• Changes in metabolic control: Average sensor glucose

  Baseline, 3 months and 6 months

• Changes in metabolic control: Glucose Management Indicator (GMI)

  Baseline, 3 months and 6 months

Study Arms (4)

Placebo + Standard lifestyle recommendations

NO INTERVENTION

Participants in this group will not undergo any intervention beyond what is routinely performed in clinical practice. This group will receive microencapsulated placebo.

Placebo + Intensive lifestyle modification

PLACEBO COMPARATOR

Other: Intensive lifestyle modification (hypocaloric Mediterranean diet and promotion of physical activity)

Butyrate

EXPERIMENTAL

Dietary Supplement: Butyrate

Intensive lifestyle modification + butyrate

EXPERIMENTAL

Dietary Supplement: Intensive lifestyle modification + butyrate

Interventions

Intensive lifestyle modification (hypocaloric Mediterranean diet and promotion of physical activity) OTHER

Participants will be advised to follow a Mediterranean diet, characterized by the use of olive oil as the main source of fat, regular consumption of vegetables, fruits, legumes, and fish, reduced consumption of red meat and processed meats, and elimination of sugar-sweetened beverages, industrial pastries, and confectionery. The Mediterranean diet will include a 30% energy restriction based on estimated energy needs (Harris-Benedict equation). Participants will also be advised to perform ≥150 minutes of moderate-to-vigorous physical activity per week, distributed over at least 3 days, with no more than 2 consecutive days without activity, and to perform 2-3 resistance training sessions per week on non-consecutive days. This group will receive microencapsulated placebo.

Placebo + Intensive lifestyle modification

Butyrate DIETARY_SUPPLEMENT

Participants randomized to this group will receive microencapsulated sodium butyrate (MSB). Each sachet contains 750 mg sodium butyrate and 1750 mg triglyceride matrix (total 2,500 mg). Participants will take 3 sachets daily (total daily dose: 2.25 g butyrate): one in the morning, one at midday, and one in the evening.

Butyrate

Intensive lifestyle modification + butyrate DIETARY_SUPPLEMENT

Participants will undergo both intensive lifestyle modification and receive butyrate as described above. This study will be placebo-controlled: participants not randomized to butyrate will receive placebo sachets identical in size, color, appearance, and taste to the investigational product but without butyrate. Placebo will also be taken three times daily following the same schedule.

Intensive lifestyle modification + butyrate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead

Study Sites (1)

Hospital Regional Universitario de Málaga, FIMABIS

Málaga, Málaga, 29009, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Butyrates

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Central Study Contacts

Jose Carlos Fernández García, MD

CONTACT

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

Virginia Soria Utrilla, PhD

CONTACT

virginia.soria.sspa@juntadeandalucia.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both butyrate and placebo will be packaged and labeled identically to ensure double blinding of participants and study staff.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 6, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): February 15, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-07

Locations

ES (1)