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

1 июля 2026 г. обновлено: 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.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

200

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Учебное резервное копирование контактов

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Факторное присвоение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Без вмешательства: 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.
Плацебо Компаратор: Placebo + Intensive lifestyle modification
Другой: 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.
Экспериментальный: Butyrate
Диетическая добавка: 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.
Экспериментальный: Intensive lifestyle modification + butyrate
Диетическая добавка: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Changes in Controlled Attenuation Parameter (CAP) by hepatic elastography (FibroScan®): Controlled Attenuation Parameter (CAP)
Временное ограничение: 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
Временное ограничение: Baseline, 3 month and 6 month
Measured in : kPa
Baseline, 3 month and 6 month

Вторичные показатели результатов

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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

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

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

15 сентября 2026 г.

Первичное завершение (Оцененный)

15 сентября 2027 г.

Завершение исследования (Оцененный)

15 февраля 2028 г.

Даты регистрации исследования

Первый отправленный

24 июня 2026 г.

Впервые представлено, что соответствует критериям контроля качества

1 июля 2026 г.

Первый опубликованный (Действительный)

6 июля 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

6 июля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

1 июля 2026 г.

Последняя проверка

1 июля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • BEAM-T1D Study

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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