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

1 de julho de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

200

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição fatorial
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: 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 Placebo: Placebo + Intensive lifestyle modification
Outro: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Changes in Controlled Attenuation Parameter (CAP) by hepatic elastography (FibroScan®): Controlled Attenuation Parameter (CAP)
Prazo: 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
Prazo: Baseline, 3 month and 6 month
Measured in : kPa
Baseline, 3 month and 6 month

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Changes in insulin resistance: eGDR
Prazo: Baseline, 3 months and 6 months
Measured in mg/kg/min
Baseline, 3 months and 6 months
Changes in metabolic control: Glucose
Prazo: Baseline, 3 months and 6 months
Measured in mg/dl
Baseline, 3 months and 6 months
Changes in metabolic control: HbA1c
Prazo: Baseline, 3 months and 6 months
Measured in mmol/mol
Baseline, 3 months and 6 months
Changes in metabolic control: Average sensor glucose
Prazo: Baseline, 3 months and 6 months
Measured in mg/dl
Baseline, 3 months and 6 months
Changes in metabolic control: Glucose Management Indicator (GMI)
Prazo: Baseline, 3 months and 6 months
Measured in %
Baseline, 3 months and 6 months
Changes in metabolic control: Time in range (TIR)
Prazo: Baseline, 3 months and 6 months
Measured in %
Baseline, 3 months and 6 months
Changes in metabolic control: Time Above Range (TAR)
Prazo: Baseline, 3 months and 6 months
Measured in %
Baseline, 3 months and 6 months
Changes in metabolic control: Time Below Range (TBR)
Prazo: Baseline, 3 months and 6 months
Measured in minutes or hours
Baseline, 3 months and 6 months
Changes in body composition: Weight
Prazo: Baseline, 3 months and 6 months
Measured in kg
Baseline, 3 months and 6 months
Changes in body composition: Body mass index (BMI)
Prazo: 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
Prazo: Baseline, 3 months and 6 months
Measured in cm2
Baseline, 3 months and 6 months
Changes in body composition: Fat mass
Prazo: Baseline, 3 months and 6 months
Measured in kg
Baseline, 3 months and 6 months
Changes in body composition: Fat-free mass
Prazo: Baseline, 3 months and 6 months
Measured in kg
Baseline, 3 months and 6 months
Changes in body composition: Body cellular mass
Prazo: Baseline, 3 months and 6 months
Measured in kg
Baseline, 3 months and 6 months
Changes in body composition: Skeletical muscle mass
Prazo: Baseline, 3 months and 6 months
Measured in kg
Baseline, 3 months and 6 months
Changes in body composition: Appendicular skeletal muscle mass
Prazo: Baseline, 3 months and 6 months
Measured in kg
Baseline, 3 months and 6 months
Changes in blood pressure: Systolic blood pressure
Prazo: Baseline, 3 months and 6 months
Measured in mmHg
Baseline, 3 months and 6 months
Changes in blood pressure: Diastolic blood pressure
Prazo: Baseline, 3 months and 6 months
Measured in mmHg
Baseline, 3 months and 6 months
Changes in lipid profile: Total cholesterol
Prazo: Baseline, 3 months and 6 months
Measured in mg/dl
Baseline, 3 months and 6 months
Changes in lipid profile: HDL
Prazo: Baseline, 3 months and 6 months
Measured in mg/dl
Baseline, 3 months and 6 months
Changes in lipid profile: LDL
Prazo: Baseline, 3 months and 6 months
Measured in mg/dl
Baseline, 3 months and 6 months
Changes in adipokines: Leptin
Prazo: Baseline, 3 months and 6 months
Measured in ng/mL
Baseline, 3 months and 6 months
Changes in adipokines: Adiponectin
Prazo: Baseline, 3 months and 6 months
Measured in μg/mL
Baseline, 3 months and 6 months
Changes in hepatokines: GDF-15
Prazo: Baseline, 3 months and 6 months
Measured in ng/mL
Baseline, 3 months and 6 months
Changes in hepatokines: FGF-21
Prazo: Baseline, 3 months and 6 months
Measured in ng/mL
Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-10
Prazo: Baseline, 3 months and 6 months
Measured in pg/mL
Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-1b
Prazo: Baseline, 3 months and 6 months
Measured in pg/mL
Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-6
Prazo: Baseline, 3 months and 6 months
Measured in pg/mL
Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-8
Prazo: Baseline, 3 months and 6 months
Measured in pg/mL
Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-12
Prazo: Baseline, 3 months and 6 months
Measured in pg/mL
Baseline, 3 months and 6 months
Changes in inflammatory markers: TNF-α
Prazo: Baseline, 3 months and 6 months
Measured in pg/mL
Baseline, 3 months and 6 months
Changes in intestinal permeability: Zonuline
Prazo: Baseline, 3 months and 6 months
Measured in ng/mL
Baseline, 3 months and 6 months
Changes in short-chain fatty acid levels: Butyrate
Prazo: Baseline, 3 months and 6 months
Measured in μmol/kg
Baseline, 3 months and 6 months
Changes in gut microbiota: phylum, genus, species
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline, 3 months and 6 months
Measured in cm
Baseline, 3 months and 6 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de setembro de 2026

Conclusão Primária (Estimado)

15 de setembro de 2027

Conclusão do estudo (Estimado)

15 de fevereiro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

24 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de julho de 2026

Primeira postagem (Real)

6 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • BEAM-T1D Study

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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