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

1 de julio de 2026 actualizado por: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Butyrate or Intensive Lifestyle Modification in Type 1 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease: A Factorial Randomized Clinical Trial

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

200

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Placebo + Standard lifestyle recommendations
Participants in this group will not undergo any intervention beyond what is routinely performed in clinical practice. This group will receive microencapsulated placebo.
Comparador de placebos: Placebo + Intensive lifestyle modification
Otro: Intensive lifestyle modification (hypocaloric Mediterranean diet and promotion of physical activity)
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.
Experimental: Butyrate
Suplemento dietético: Butyrate
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.
Experimental: Intensive lifestyle modification + butyrate
Suplemento dietético: Intensive lifestyle modification + butyrate

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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in Controlled Attenuation Parameter (CAP) by hepatic elastography (FibroScan®): Controlled Attenuation Parameter (CAP)
Periodo de tiempo: Baseline, 3 month and 6 month
Measured in dB/m
Baseline, 3 month and 6 month
Changes in Controlled Attenuation Parameter (CAP) by hepatic elastography (FibroScan®): Liver Stiffness Measurement
Periodo de tiempo: Baseline, 3 month and 6 month
Measured in : kPa
Baseline, 3 month and 6 month

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in insulin resistance: eGDR
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in mg/kg/min
Baseline, 3 months and 6 months
Changes in metabolic control: Glucose
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in mg/dl
Baseline, 3 months and 6 months
Changes in metabolic control: HbA1c
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in mmol/mol
Baseline, 3 months and 6 months
Changes in metabolic control: Average sensor glucose
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in mg/dl
Baseline, 3 months and 6 months
Changes in metabolic control: Glucose Management Indicator (GMI)
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in %
Baseline, 3 months and 6 months
Changes in metabolic control: Time in range (TIR)
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in %
Baseline, 3 months and 6 months
Changes in metabolic control: Time Above Range (TAR)
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in %
Baseline, 3 months and 6 months
Changes in metabolic control: Time Below Range (TBR)
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in minutes or hours
Baseline, 3 months and 6 months
Changes in body composition: Weight
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in kg
Baseline, 3 months and 6 months
Changes in body composition: Body mass index (BMI)
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in kg/m2
Baseline, 3 months and 6 months
Changes in body composition: Muscular area of rectus anterior
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in cm2
Baseline, 3 months and 6 months
Changes in body composition: Fat mass
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in kg
Baseline, 3 months and 6 months
Changes in body composition: Fat-free mass
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in kg
Baseline, 3 months and 6 months
Changes in body composition: Body cellular mass
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in kg
Baseline, 3 months and 6 months
Changes in body composition: Skeletical muscle mass
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in kg
Baseline, 3 months and 6 months
Changes in body composition: Appendicular skeletal muscle mass
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in kg
Baseline, 3 months and 6 months
Changes in blood pressure: Systolic blood pressure
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in mmHg
Baseline, 3 months and 6 months
Changes in blood pressure: Diastolic blood pressure
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in mmHg
Baseline, 3 months and 6 months
Changes in lipid profile: Total cholesterol
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in mg/dl
Baseline, 3 months and 6 months
Changes in lipid profile: HDL
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in mg/dl
Baseline, 3 months and 6 months
Changes in lipid profile: LDL
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in mg/dl
Baseline, 3 months and 6 months
Changes in adipokines: Leptin
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in ng/mL
Baseline, 3 months and 6 months
Changes in adipokines: Adiponectin
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in μg/mL
Baseline, 3 months and 6 months
Changes in hepatokines: GDF-15
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in ng/mL
Baseline, 3 months and 6 months
Changes in hepatokines: FGF-21
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in ng/mL
Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-10
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in pg/mL
Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-1b
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in pg/mL
Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-6
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in pg/mL
Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-8
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in pg/mL
Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-12
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in pg/mL
Baseline, 3 months and 6 months
Changes in inflammatory markers: TNF-α
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in pg/mL
Baseline, 3 months and 6 months
Changes in intestinal permeability: Zonuline
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in ng/mL
Baseline, 3 months and 6 months
Changes in short-chain fatty acid levels: Butyrate
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in μmol/kg
Baseline, 3 months and 6 months
Changes in gut microbiota: phylum, genus, species
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in relative abundance, alpha diversity, beta diversity
Baseline, 3 months and 6 months
Change from baseline in Mediterranean Diet Adherence at 3 and 6 months
Periodo de tiempo: Baseline, 3 months and 6 months
The 17-item Mediterranean Diet Adherence Questionnaire assesses dietary habits through 17 questions regarding the consumption of traditional Mediterranean diet components (e.g., olive oil, vegetables, fruits, fish). Each item is scored as 0 (does not meet the criterion) or 1 (meets the criterion), with a total score ranging from 0 (minimum score) to 17 (maximum score). Higher scores indicate greater adherence to the Mediterranean diet.
Baseline, 3 months and 6 months
Change from baseline in Physical Activity Level at 3 and 6 months
Periodo de tiempo: Baseline, 3 months and 6 months

The Short version of the International Physical Activity Questionnaire (IPAQ) assesses physical activity across three intensities (vigorous, moderate, and walking) over the last 7 days. Total physical activity is calculated as a continuous variable expressed in Metabolic Equivalent of Task minutes per week (MET-minutes/week), summing the duration (minutes/week) of each activity type multiplied by its specific MET value (walking = 3.3, moderate = 4.0, vigorous = 8.0). Higher MET-minutes/week indicate higher levels of physical activity.

Sedentary behavior is assessed by measuing the total time spent sitting during a typical weekday over the last 7 days (including time at work, home, study, or leisure). The score is expressed as total minutes or hours of sitting time per day. Higher values indicate greater sedentary behavior.
Baseline, 3 months and 6 months
Change from baseline in Long-term Physical Activity Patterns at 3 and 6 months
Periodo de tiempo: Baseline, 3 months and 6 months
The validated version of the Nurses' Health Study and Health Professionals' Follow-up Study physical activity questionnaire assesses the average time per week spent on specific recreational activities (e.g., walking, jogging, cycling, swimming, running) over a longer recall period. Each activity is assigned a standard MET value based on intensity (the number of METs corresponding to each activity were calculated using the Compendium of Physical Activities). Total activity is computed as the sum of MET-hours per week (MET-hours/week) by multiplying the weekly hours dedicated to each activity by its corresponding MET value. Higher scores reflect greater energy expenditure from physical activity.
Baseline, 3 months and 6 months
Changes in body composition: Height
Periodo de tiempo: Baseline, 3 months and 6 months
Measured in cm
Baseline, 3 months and 6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de septiembre de 2026

Finalización primaria (Estimado)

15 de septiembre de 2027

Finalización del estudio (Estimado)

15 de febrero de 2028

Fechas de registro del estudio

Enviado por primera vez

24 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de julio de 2026

Publicado por primera vez (Actual)

6 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • BEAM-T1D Study

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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