An interventional study of Intensive lifestyle modification (hypocaloric Mediterranean diet and promotion of physical activity) and Butyrate in Type 1 Diabetes, sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Not applicable, Interventional, and Treatment
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 200 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud is the lead sponsor of 71 studies on the registry; 23 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will not undergo any intervention beyond what is routinely performed in clinical practice. This group will receive microencapsulated placebo.
Other: Intensive lifestyle modification (hypocaloric Mediterranean diet and promotion of physical activity)
Dietary Supplement: Butyrate
Dietary Supplement: Intensive lifestyle modification + butyrate
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.
Drug pages: Butyrates · Butyric Acid
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.
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.
Changes in Controlled Attenuation Parameter (CAP) by hepatic elastography (FibroScan®): Controlled Attenuation Parameter (CAP)
Measured in dB/m
Time frame: Baseline, 3 month and 6 month
Changes in Controlled Attenuation Parameter (CAP) by hepatic elastography (FibroScan®): Liver Stiffness Measurement
Measured in : kPa
Time frame: Baseline, 3 month and 6 month
Changes in insulin resistance: eGDR
Measured in mg/kg/min
Time frame: Baseline, 3 months and 6 months
Changes in metabolic control: Glucose
Measured in mg/dl
Time frame: Baseline, 3 months and 6 months
Changes in metabolic control: HbA1c
Measured in mmol/mol
Time frame: Baseline, 3 months and 6 months
Changes in metabolic control: Average sensor glucose
Measured in mg/dl
Time frame: Baseline, 3 months and 6 months
Changes in metabolic control: Glucose Management Indicator (GMI)
Measured in %
Time frame: Baseline, 3 months and 6 months
Changes in metabolic control: Time in range (TIR)
Measured in %
Time frame: Baseline, 3 months and 6 months
Changes in metabolic control: Time Above Range (TAR)
Measured in %
Time frame: Baseline, 3 months and 6 months
Changes in metabolic control: Time Below Range (TBR)
Measured in minutes or hours
Time frame: Baseline, 3 months and 6 months
Changes in body composition: Weight
Measured in kg
Time frame: Baseline, 3 months and 6 months
Changes in body composition: Body mass index (BMI)
Measured in kg/m2
Time frame: Baseline, 3 months and 6 months
Changes in body composition: Muscular area of rectus anterior
Measured in cm2
Time frame: Baseline, 3 months and 6 months
Changes in body composition: Fat mass
Measured in kg
Time frame: Baseline, 3 months and 6 months
Changes in body composition: Fat-free mass
Measured in kg
Time frame: Baseline, 3 months and 6 months
Changes in body composition: Body cellular mass
Measured in kg
Time frame: Baseline, 3 months and 6 months
Changes in body composition: Skeletical muscle mass
Measured in kg
Time frame: Baseline, 3 months and 6 months
Changes in body composition: Appendicular skeletal muscle mass
Measured in kg
Time frame: Baseline, 3 months and 6 months
Changes in blood pressure: Systolic blood pressure
Measured in mmHg
Time frame: Baseline, 3 months and 6 months
Changes in blood pressure: Diastolic blood pressure
Measured in mmHg
Time frame: Baseline, 3 months and 6 months
Changes in lipid profile: Total cholesterol
Measured in mg/dl
Time frame: Baseline, 3 months and 6 months
Changes in lipid profile: HDL
Measured in mg/dl
Time frame: Baseline, 3 months and 6 months
Changes in lipid profile: LDL
Measured in mg/dl
Time frame: Baseline, 3 months and 6 months
Changes in adipokines: Leptin
Measured in ng/mL
Time frame: Baseline, 3 months and 6 months
Changes in adipokines: Adiponectin
Measured in μg/mL
Time frame: Baseline, 3 months and 6 months
Changes in hepatokines: GDF-15
Measured in ng/mL
Time frame: Baseline, 3 months and 6 months
Changes in hepatokines: FGF-21
Measured in ng/mL
Time frame: Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-10
Measured in pg/mL
Time frame: Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-1b
Measured in pg/mL
Time frame: Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-6
Measured in pg/mL
Time frame: Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-8
Measured in pg/mL
Time frame: Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-12
Measured in pg/mL
Time frame: Baseline, 3 months and 6 months
Changes in inflammatory markers: TNF-α
Measured in pg/mL
Time frame: Baseline, 3 months and 6 months
Changes in intestinal permeability: Zonuline
Measured in ng/mL
Time frame: Baseline, 3 months and 6 months
Changes in short-chain fatty acid levels: Butyrate
Measured in μmol/kg
Time frame: Baseline, 3 months and 6 months
Changes in gut microbiota: phylum, genus, species
Measured in relative abundance, alpha diversity, beta diversity
Time frame: Baseline, 3 months and 6 months
Change from baseline in Mediterranean Diet Adherence at 3 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.
Time frame: Baseline, 3 months and 6 months
Change from baseline in Physical Activity Level at 3 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.
Time frame: Baseline, 3 months and 6 months
Change from baseline in Long-term Physical Activity Patterns at 3 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.
Time frame: Baseline, 3 months and 6 months
Changes in body composition: Height
Measured in cm
Time frame: Baseline, 3 months and 6 months
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Butyrates · Butyric Acid
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud