Type 1 DiabetesNCT07684248
Butyrate or Intensive Lifestyle Modification in Type 1 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease
A study testing Intensive lifestyle modification (hypocaloric Mediterranean diet and promotion of physical activity), Butyrate and Intensive lifestyle modification + butyrate in people with Type 1 Diabetes, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Intensive lifestyle modification (hypocaloric Mediterranean diet and promotion of physical activity), Butyrate and Intensive lifestyle modification + butyrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2026to 15 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Virginia Soria Utrilla, PhD contact
Spain1 site
Hospital Regional Universitario de Málaga, FIMABIS
Málaga, Málaga, 29009
Jose Carlos Fernández García, MD, 951290343, josec.fernandez.garcia.sspa@juntadeandalucia.es
About this study
Official title: 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.
Read more
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.
- Conditions
- Type 1 Diabetes
- Being tested
- Intensive lifestyle modification (hypocaloric Mediterranean diet and promotion of physical activity), Butyrate, Intensive lifestyle modification + butyrate
- Keywords
- Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Short-Chain Fatty Acids (SCFAs), Sodium Butyrate, Type 1 Diabetes (T1D)
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
ButyrateDietary 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 + butyrateDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo + Standard lifestyle recommendations | No intervention | Participants in this group will not undergo any intervention beyond what is routinely performed in clinical practice. This group will receive microencapsulated placebo. |
| Placebo + Intensive lifestyle modification | Placebo comparator | Not described Receives: Other: Intensive lifestyle modification (hypocaloric Mediterranean diet and promotion of physical activity) |
| Butyrate | Experimental | Not described Receives: Dietary Supplement: Butyrate |
| Intensive lifestyle modification + butyrate | Experimental | Not described Receives: Dietary Supplement: Intensive lifestyle modification + butyrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Controlled Attenuation Parameter (CAP) by hepatic elastography (FibroScan®): Controlled Attenuation Parameter (CAP)
Measured in dB/m
Measured: Baseline, 3 month and 6 month
Changes in Controlled Attenuation Parameter (CAP) by hepatic elastography (FibroScan®): Liver Stiffness Measurement
Measured in : kPa
Measured: Baseline, 3 month and 6 month
Secondary outcomes (38)
Changes in insulin resistance: eGDR
Measured in mg/kg/min
Measured: Baseline, 3 months and 6 months
Changes in metabolic control: Glucose
Measured in mg/dl
Measured: Baseline, 3 months and 6 months
Changes in metabolic control: HbA1c
Measured in mmol/mol
Measured: Baseline, 3 months and 6 months
Changes in metabolic control: Average sensor glucose
Measured in mg/dl
Measured: Baseline, 3 months and 6 months
Changes in metabolic control: Glucose Management Indicator (GMI)
Measured in %
Measured: Baseline, 3 months and 6 months
Changes in metabolic control: Time in range (TIR)
Measured in %
Measured: Baseline, 3 months and 6 months
Changes in metabolic control: Time Above Range (TAR)
Measured in %
Measured: Baseline, 3 months and 6 months
Changes in metabolic control: Time Below Range (TBR)
Measured in minutes or hours
Measured: Baseline, 3 months and 6 months
Changes in body composition: Weight
Measured in kg
Measured: Baseline, 3 months and 6 months
Changes in body composition: Body mass index (BMI)
Measured in kg/m2
Measured: Baseline, 3 months and 6 months
Changes in body composition: Muscular area of rectus anterior
Measured in cm2
Measured: Baseline, 3 months and 6 months
Changes in body composition: Fat mass
Measured in kg
Measured: Baseline, 3 months and 6 months
Changes in body composition: Fat-free mass
Measured in kg
Measured: Baseline, 3 months and 6 months
Changes in body composition: Body cellular mass
Measured in kg
Measured: Baseline, 3 months and 6 months
Changes in body composition: Skeletical muscle mass
Measured in kg
Measured: Baseline, 3 months and 6 months
Changes in body composition: Appendicular skeletal muscle mass
Measured in kg
Measured: Baseline, 3 months and 6 months
Changes in blood pressure: Systolic blood pressure
Measured in mmHg
Measured: Baseline, 3 months and 6 months
Changes in blood pressure: Diastolic blood pressure
Measured in mmHg
Measured: Baseline, 3 months and 6 months
Changes in lipid profile: Total cholesterol
Measured in mg/dl
Measured: Baseline, 3 months and 6 months
Changes in lipid profile: HDL
Measured in mg/dl
Measured: Baseline, 3 months and 6 months
Changes in lipid profile: LDL
Measured in mg/dl
Measured: Baseline, 3 months and 6 months
Changes in adipokines: Leptin
Measured in ng/mL
Measured: Baseline, 3 months and 6 months
Changes in adipokines: Adiponectin
Measured in μg/mL
Measured: Baseline, 3 months and 6 months
Changes in hepatokines: GDF-15
Measured in ng/mL
Measured: Baseline, 3 months and 6 months
Changes in hepatokines: FGF-21
Measured in ng/mL
Measured: Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-10
Measured in pg/mL
Measured: Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-1b
Measured in pg/mL
Measured: Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-6
Measured in pg/mL
Measured: Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-8
Measured in pg/mL
Measured: Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-12
Measured in pg/mL
Measured: Baseline, 3 months and 6 months
Changes in inflammatory markers: TNF-α
Measured in pg/mL
Measured: Baseline, 3 months and 6 months
Changes in intestinal permeability: Zonuline
Measured in ng/mL
Measured: Baseline, 3 months and 6 months
Changes in short-chain fatty acid levels: Butyrate
Measured in μmol/kg
Measured: Baseline, 3 months and 6 months
Changes in gut microbiota: phylum, genus, species
Measured in relative abundance, alpha diversity, beta diversity
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months and 6 months
Changes in body composition: Height
Measured in cm
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684248
- Sponsor's protocol ID
- BEAM-T1D Study
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Butyrate or Intensive Lifestyle Modification in Type 1 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease: A Factorial Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07684248
- Acronym / sponsor ID
- BEAM-T1D Study
- Conditions
- Type 1 Diabetes
- Keywords
- Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Short-Chain Fatty Acids (SCFAs), Sodium Butyrate, Type 1 Diabetes (T1D)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Feb 2028 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo + Standard lifestyle recommendations | No intervention | –Participants in this group will not undergo any intervention beyond what is routinely performed in clinical practice. This group will receive microencapsulated placebo. |
| Placebo + Intensive lifestyle modification | Placebo comparator | Other: Intensive lifestyle modification (hypocaloric Mediterranean diet and promotion of physical activity) |
| Butyrate | Experimental | Dietary Supplement: Butyrate |
| Intensive lifestyle modification + butyrate | Experimental | Dietary Supplement: Intensive lifestyle modification + butyrate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Placebo + Intensive lifestyle modification |
| ButyrateParticipants 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. | Dietary supplement | Butyrate |
| Intensive lifestyle modification + butyrateParticipants 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. | Dietary supplement | Intensive lifestyle modification + butyrate |
Primary outcome
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
Changes in Controlled Attenuation Parameter (CAP) by hepatic elastography (FibroScan®): Liver Stiffness Measurement
Time frame: Baseline, 3 month and 6 month
Measured in : kPa
38 secondary outcomes
Changes in insulin resistance: eGDR
Time frame: Baseline, 3 months and 6 months
Changes in metabolic control: Glucose
Time frame: Baseline, 3 months and 6 months
Changes in metabolic control: HbA1c
Time frame: Baseline, 3 months and 6 months
Changes in metabolic control: Average sensor glucose
Time frame: Baseline, 3 months and 6 months
Changes in metabolic control: Glucose Management Indicator (GMI)
Time frame: Baseline, 3 months and 6 months
Changes in metabolic control: Time in range (TIR)
Time frame: Baseline, 3 months and 6 months
Changes in metabolic control: Time Above Range (TAR)
Time frame: Baseline, 3 months and 6 months
Changes in metabolic control: Time Below Range (TBR)
Time frame: Baseline, 3 months and 6 months
Changes in body composition: Weight
Time frame: Baseline, 3 months and 6 months
Changes in body composition: Body mass index (BMI)
Time frame: Baseline, 3 months and 6 months
Changes in body composition: Muscular area of rectus anterior
Time frame: Baseline, 3 months and 6 months
Changes in body composition: Fat mass
Time frame: Baseline, 3 months and 6 months
Changes in body composition: Fat-free mass
Time frame: Baseline, 3 months and 6 months
Changes in body composition: Body cellular mass
Time frame: Baseline, 3 months and 6 months
Changes in body composition: Skeletical muscle mass
Time frame: Baseline, 3 months and 6 months
Changes in body composition: Appendicular skeletal muscle mass
Time frame: Baseline, 3 months and 6 months
Changes in blood pressure: Systolic blood pressure
Time frame: Baseline, 3 months and 6 months
Changes in blood pressure: Diastolic blood pressure
Time frame: Baseline, 3 months and 6 months
Changes in lipid profile: Total cholesterol
Time frame: Baseline, 3 months and 6 months
Changes in lipid profile: HDL
Time frame: Baseline, 3 months and 6 months
Changes in lipid profile: LDL
Time frame: Baseline, 3 months and 6 months
Changes in adipokines: Leptin
Time frame: Baseline, 3 months and 6 months
Changes in adipokines: Adiponectin
Time frame: Baseline, 3 months and 6 months
Changes in hepatokines: GDF-15
Time frame: Baseline, 3 months and 6 months
Changes in hepatokines: FGF-21
Time frame: Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-10
Time frame: Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-1b
Time frame: Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-6
Time frame: Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-8
Time frame: Baseline, 3 months and 6 months
Changes in inflammatory markers: IL-12
Time frame: Baseline, 3 months and 6 months
Changes in inflammatory markers: TNF-α
Time frame: Baseline, 3 months and 6 months
Changes in intestinal permeability: Zonuline
Time frame: Baseline, 3 months and 6 months
Changes in short-chain fatty acid levels: Butyrate
Time frame: Baseline, 3 months and 6 months
Changes in gut microbiota: phylum, genus, species
Time frame: Baseline, 3 months and 6 months
Change from baseline in Mediterranean Diet Adherence at 3 and 6 months
Time frame: Baseline, 3 months and 6 months
Change from baseline in Physical Activity Level at 3 and 6 months
Time frame: Baseline, 3 months and 6 months
Change from baseline in Long-term Physical Activity Patterns at 3 and 6 months
Time frame: Baseline, 3 months and 6 months
Changes in body composition: Height
Time frame: Baseline, 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Virginia Soria Utrilla, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive lifestyle modification (hypocaloric Mediterranean diet and promotion of physical activity), Butyrate and Intensive lifestyle modification + butyrate in people with Type 1 Diabetes, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose Carlos Fernández García, MD (951290343, josec.fernandez.garcia.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Controlled Attenuation Parameter (CAP) by hepatic elastography (FibroScan®): Controlled Attenuation Parameter (CAP) (time frame: Baseline, 3 month and 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.