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NCT Number: NCT07684248

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Regional Universitario de Málaga, FIMABIS

Málaga, 29009, Spain

Location contact

Jose Carlos Fernández García, MD

CONTACT

[email protected]

951290343

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

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

    Time frame: Baseline, 3 month and 6 month

    Measured in dB/m

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

    Time frame: Baseline, 3 month and 6 month

    Measured in : kPa

Secondary outcomes

  1. Changes in insulin resistance: eGDR

    Time frame: Baseline, 3 months and 6 months

    Measured in mg/kg/min

  2. Changes in metabolic control: Glucose

    Time frame: Baseline, 3 months and 6 months

    Measured in mg/dl

  3. Changes in metabolic control: HbA1c

    Time frame: Baseline, 3 months and 6 months

    Measured in mmol/mol

  4. Changes in metabolic control: Average sensor glucose

    Time frame: Baseline, 3 months and 6 months

    Measured in mg/dl

  5. Changes in metabolic control: Glucose Management Indicator (GMI)

    Time frame: Baseline, 3 months and 6 months

    Measured in %

  6. Changes in metabolic control: Time in range (TIR)

    Time frame: Baseline, 3 months and 6 months

    Measured in %

  7. Changes in metabolic control: Time Above Range (TAR)

    Time frame: Baseline, 3 months and 6 months

    Measured in %

  8. Changes in metabolic control: Time Below Range (TBR)

    Time frame: Baseline, 3 months and 6 months

    Measured in minutes or hours

  9. Changes in body composition: Weight

    Time frame: Baseline, 3 months and 6 months

    Measured in kg

  10. Changes in body composition: Body mass index (BMI)

    Time frame: Baseline, 3 months and 6 months

    Measured in kg/m2

  11. Changes in body composition: Muscular area of rectus anterior

    Time frame: Baseline, 3 months and 6 months

    Measured in cm2

  12. Changes in body composition: Fat mass

    Time frame: Baseline, 3 months and 6 months

    Measured in kg

  13. Changes in body composition: Fat-free mass

    Time frame: Baseline, 3 months and 6 months

    Measured in kg

  14. Changes in body composition: Body cellular mass

    Time frame: Baseline, 3 months and 6 months

    Measured in kg

  15. Changes in body composition: Skeletical muscle mass

    Time frame: Baseline, 3 months and 6 months

    Measured in kg

  16. Changes in body composition: Appendicular skeletal muscle mass

    Time frame: Baseline, 3 months and 6 months

    Measured in kg

  17. Changes in blood pressure: Systolic blood pressure

    Time frame: Baseline, 3 months and 6 months

    Measured in mmHg

  18. Changes in blood pressure: Diastolic blood pressure

    Time frame: Baseline, 3 months and 6 months

    Measured in mmHg

  19. Changes in lipid profile: Total cholesterol

    Time frame: Baseline, 3 months and 6 months

    Measured in mg/dl

  20. Changes in lipid profile: HDL

    Time frame: Baseline, 3 months and 6 months

    Measured in mg/dl

  21. Changes in lipid profile: LDL

    Time frame: Baseline, 3 months and 6 months

    Measured in mg/dl

  22. Changes in adipokines: Leptin

    Time frame: Baseline, 3 months and 6 months

    Measured in ng/mL

  23. Changes in adipokines: Adiponectin

    Time frame: Baseline, 3 months and 6 months

    Measured in μg/mL

  24. Changes in hepatokines: GDF-15

    Time frame: Baseline, 3 months and 6 months

    Measured in ng/mL

  25. Changes in hepatokines: FGF-21

    Time frame: Baseline, 3 months and 6 months

    Measured in ng/mL

  26. Changes in inflammatory markers: IL-10

    Time frame: Baseline, 3 months and 6 months

    Measured in pg/mL

  27. Changes in inflammatory markers: IL-1b

    Time frame: Baseline, 3 months and 6 months

    Measured in pg/mL

  28. Changes in inflammatory markers: IL-6

    Time frame: Baseline, 3 months and 6 months

    Measured in pg/mL

  29. Changes in inflammatory markers: IL-8

    Time frame: Baseline, 3 months and 6 months

    Measured in pg/mL

  30. Changes in inflammatory markers: IL-12

    Time frame: Baseline, 3 months and 6 months

    Measured in pg/mL

  31. Changes in inflammatory markers: TNF-α

    Time frame: Baseline, 3 months and 6 months

    Measured in pg/mL

  32. Changes in intestinal permeability: Zonuline

    Time frame: Baseline, 3 months and 6 months

    Measured in ng/mL

  33. Changes in short-chain fatty acid levels: Butyrate

    Time frame: Baseline, 3 months and 6 months

    Measured in μmol/kg

  34. Changes in gut microbiota: phylum, genus, species

    Time frame: Baseline, 3 months and 6 months

    Measured in relative abundance, alpha diversity, beta diversity

  35. Change from baseline in Mediterranean Diet Adherence at 3 and 6 months

    Time frame: 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.

  36. Change from baseline in Physical Activity Level at 3 and 6 months

    Time frame: 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.

  37. Change from baseline in Long-term Physical Activity Patterns at 3 and 6 months

    Time frame: 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.

  38. Changes in body composition: Height

    Time frame: Baseline, 3 months and 6 months

    Measured in cm

Study contacts

Contact information is provided by the study sponsor or research team.

Jose Carlos Fernández García, MD

CONTACT

[email protected]

951290343

Virginia Soria Utrilla, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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