MAFLDDISMANCT07233486
A Multicenter, Randomized, Crossover Clinical Trial Study of Digital Intelligence Software in Patients With MAFLD
A study testing Digital Intelligence Software Intervention Group in people with MAFLD, run by The Affiliated Hospital of Hangzhou Normal University at 1 site in China.
Trial summary
Cirrhosis associated with metabolic associated fatty liver disease (MAFLD) can lead to a series of adverse outcomes in and outside the liver, but there is no approved treatment so far. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- MAFLD
- What is being tested?
- Digital Intelligence Software Intervention Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 30 Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18-65 years with a BMI of 24-35 kg/m².
- Confirmed diagnosis of Metabolic-associated Fatty Liver Disease (MAFLD), defined by a FibroScan® result > 248 dB/m or an MRI-PDFF > 5%.
- Willing and able to provide written informed consent and comply with the study protocol, including the use of a compatible smartphone for digital health components.
- If treated for Type 2 Diabetes Mellitus (T2DM), must be on a stable medication regimen for at least 3 months prior to baseline (Day 0), with the expectation to maintain stability throughout the study barring medical necessity.
- If taking medications with potential NASH-remitting effects (e.g., vitamin E, thiazolidinediones), must be on a stable dose for at least 3 months prior to Day 0.
Who cannot join
- Subjects were excluded from participation if they met any of the following criteria, based on the most recent pre-randomization assessments:
- Evidence of cirrhosis, defined as histological stage F4 or its clinical equivalent.
- History of heavy alcohol consumption (>30 g/day for males, >20 g/day for females) for more than 3 consecutive months within one year prior to screening.
- Prior or planned solid organ transplantation (excluding corneal transplants).
- Planned bariatric surgery. A history of bariatric surgery was permitted only if weight had been stable (variation <10%) for at least 3 months prior to screening.
- Presence of other chronic liver diseases, including:
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- Hepatitis B surface antigen (HBsAg) positivity.
- Hepatitis C virus (HCV) RNA positivity.
- Primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis, or overlap syndromes.
- Wilson's disease, alpha-1 antitrypsin deficiency (ZZ phenotype), or hereditary hemochromatosis.
- History of Type 1 Diabetes Mellitus. Uncontrolled Type 2 Diabetes Mellitus, defined as HbA1c >9% or current insulin therapy.
- History of hepatic decompensation events (e.g., ascites, hepatic encephalopathy, variceal hemorrhage).
- Any of the following laboratory abnormalities at screening:
- Platelet count < 150,000/mm³
- Albumin < 3.0 g/dL
- International Normalized Ratio (INR) > 1.3
- Alkaline Phosphatase (ALP) > 2 × Upper Limit of Normal (ULN)
- Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 5 × ULN
- Total Bilirubin > 1.3 × ULN (except in cases of documented Gilbert's syndrome)
- Estimated Glomerular Filtration Rate (eGFR) < 60 mL/min/1.73 m²
- Hemoglobin < 10 g/dL
- Uncontrolled thyroid dysfunction, defined as a thyroid-stimulating hormone (TSH) level < 0.1 or > 10 µIU/mL at screening.
- Documented HIV-1 or HIV-2 infection.
- Known Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.
- Significant cardiovascular history, including myocardial infarction, unstable angina, heart failure, uncontrolled arrhythmia, coronary artery bypass graft, or percutaneous coronary intervention within one year prior to screening.
- Diagnosis of malignancy within the past 2 years (except for adequately treated basal cell carcinoma or cutaneous squamous cell carcinoma).
- Severe co-morbid respiratory, cardiac, cerebrovascular, hepatic, or renal conditions that, in the investigator's judgment, would preclude safe participation in a diet and exercise intervention.
- Active, severe infection requiring parenteral antimicrobial therapy within 30 days of screening.
- Major surgery within 30 days prior to screening.
- Chronic use of medications known to promote hepatic steatosis (e.g., systemic corticosteroids, amiodarone, methotrexate, tamoxifen, valproic acid) within 3 months of screening. Short-term, low-dose corticosteroid use was permissible.
- Current or planned treatment with radiation therapy, cytotoxic chemotherapy, or immunomodulatory agents (e.g., interleukins, interferons).
- Treatment with any investigational agent within 6 months prior to screening, or prior participation in a clinical trial for NASH/MAFLD within 6 months.
- Pregnancy or lactation.
- 1.Any other condition or circumstance that, in the opinion of the Investigator, would compromise patient safety or the validity of the study data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hangzhou Normal University Hospital
Hangzhou, Zhejiang
Binbin Zhang, doctor's degree, 19921306083, Drzhangvip@163.com
About this study
Cirrhosis associated with metabolic associated fatty liver disease (MAFLD) can lead to a series of adverse outcomes in and outside the liver, but there is no approved treatment so far. In recent years, the prevalence of MAFLD-related cirrhosis in our country is increasing rapidly, but its clinical, pathological characteristics and natural prognosis are not clear, and there is a lack of standardized and effective prevention and treatment strategies.Through"Digital Intelligence software" to assist clinicians in MAFLD patients with remote data intervention, lifestyle intervention guidance and follow-up management, to evaluate the efficacy and safety of the intervention software on body weight and blood glucose in patients with MAFLD.
- Conditions
- MAFLD
- Being tested
- Digital Intelligence Software Intervention Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Intelligence Software Intervention GroupProcedure or surgery
Study participants were guided by the program officer to download and register the"Data Intelligence software (patient-side)" and to establish a relationship with the clinicians involved in the study, baseline data were collected under the guidance of the program director, health records were created, and data were collected using a software-supported"Body composition analyzer.". The participating clinicians evaluated the subjects through the"Digital Intelligence software (doctor side)", and formulated the diet and exercise program according to the individual conditions of the subjects.
| Study group | Role | What they receive |
|---|---|---|
| Life intervention group | No intervention | Detailed nutritional intervention protocols were developed according to patients' food preferences, dietary habits, physical activity levels, working conditions, sociocultural conditions, and lifestyle. Low-carbon diet and balanced diet were adopted for dietary intervention. According to the patients' basic metabolic level, overweight and fatty liver degree, a calorie restriction diet was formulated, and it was recommended to reduce 500-1000 kcal calories per day, a balanced diet of pastries and carbohydrates, with increased intake of whole grains, omega-3 fatty acid, and dietary fiber. Choose the right ingredients for your particular patient's diet |
| Digital Intelligence Software Group | Placebo comparator | Study participants were guided by the program officer to download and register the"Data Intelligence software (patient-side)" and to establish a relationship with the clinicians involved in the study, baseline data were collected under the guidance of the program director, health records were created, and data were collected using a software-supported"Body composition analyzer.". The participating clinicians evaluated the subjects through the"Digital Intelligence software (doctor side)", and formulated the diet and exercise program according to the individual conditions of the subjects. Receives: Procedure: Digital Intelligence Software Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Absolute and relative changes from baseline in body weight
Measured: 48weeks
Secondary outcomes (4)
Fasting plasma glucose
Compare the changes in fasting blood glucose before and after treatment
Measured: 48week
Liver MRI PDFF
To evaluate the effects of weight and glucose reduction interventions on proton density fat fraction (MRI-PDFF) in patients with MAFLD
Measured: 48weeks
Liver FibroScan
liver fat attenuation parameter (CAP) , liver stiffness value (LSM)
Measured: 48week
Body Mass Index (BMI)
Clarify how multiple measurements will be aggregated to arrive at one reported value weight and height will be combined to report BMI in kg/m^2)
Measured: 48week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Aug 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MAFLDStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Hangzhou Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233486
- Sponsor's protocol ID
- 2025(E2)-HS-053
- Other IDs
- 2023ZD0508704
- Acronym
- DISMA
- Status last verified
- Jul 2025
- First submitted
- 28 Aug 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study has not been completed
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Crossover Clinical Trial Study of Digital Intelligence Software in Patients With MAFLD
- ClinicalTrials.gov ID
- NCT07233486
- Acronym / sponsor ID
- DISMA / 2025(E2)-HS-053
- Conditions
- MAFLD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 18 Nov 2025 (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.
Cirrhosis associated with metabolic associated fatty liver disease (MAFLD) can lead to a series of adverse outcomes in and outside the liver, but there is no approved treatment so far. In recent years, the prevalence of MAFLD-related cirrhosis in our country is increasing rapidly, but its clinical, pathological characteristics and natural prognosis are not clear, and there is a lack of standardized and effective prevention and treatment strategies.Through"Digital Intelligence software" to assist clinicians in MAFLD patients with remote data intervention, lifestyle intervention guidance and follow-up management, to evaluate the efficacy and safety of the intervention software on body weight and blood glucose in patients with MAFLD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Life intervention group | No intervention | –Detailed nutritional intervention protocols were developed according to patients' food preferences, dietary habits, physical activity levels, working conditions, sociocultural conditions, and lifestyle. Low-carbon diet and balanced diet were adopted for dietary intervention. According to the patients' basic metabolic level, overweight and fatty liver degree, a calorie restriction diet was formulated, and it was recommended to reduce 500-1000 kcal calories per day, a balanced diet of pastries and carbohydrates, with increased intake of whole grains, omega-3 fatty acid, and dietary fiber. Choose the right ingredients for your particular patient's diet |
| Digital Intelligence Software Group | Placebo comparator | Procedure: Digital Intelligence Software Intervention GroupStudy participants were guided by the program officer to download and register the"Data Intelligence software (patient-side)" and to establish a relationship with the clinicians involved in the study, baseline data were collected under the guidance of the program director, health records were created, and data were collected using a software-supported"Body composition analyzer.". The participating clinicians evaluated the subjects through the"Digital Intelligence software (doctor side)", and formulated the diet and exercise program according to the individual conditions of the subjects. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients aged 18-65 years with a BMI of 24-35 kg/m².
- Confirmed diagnosis of Metabolic-associated Fatty Liver Disease (MAFLD), defined by a FibroScan® result > 248 dB/m or an MRI-PDFF > 5%.
- Willing and able to provide written informed consent and comply with the study protocol, including the use of a compatible smartphone for digital health components.
- If treated for Type 2 Diabetes Mellitus (T2DM), must be on a stable medication regimen for at least 3 months prior to baseline (Day 0), with the expectation to maintain stability throughout the study barring medical necessity.
- If taking medications with potential NASH-remitting effects (e.g., vitamin E, thiazolidinediones), must be on a stable dose for at least 3 months prior to Day 0.
Key exclusion criteria (34 listed)
- Subjects were excluded from participation if they met any of the following criteria, based on the most recent pre-randomization assessments:
- Evidence of cirrhosis, defined as histological stage F4 or its clinical equivalent.
- History of heavy alcohol consumption (>30 g/day for males, >20 g/day for females) for more than 3 consecutive months within one year prior to screening.
- Prior or planned solid organ transplantation (excluding corneal transplants).
- Planned bariatric surgery. A history of bariatric surgery was permitted only if weight had been stable (variation <10%) for at least 3 months prior to screening.
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 |
|---|---|---|
| Digital Intelligence Software Intervention GroupStudy participants were guided by the program officer to download and register the"Data Intelligence software (patient-side)" and to establish a relationship with the clinicians involved in the study, baseline data were collected under the guidance of the program director, health records were created, and data were collected using a software-supported"Body composition analyzer.". The participating clinicians evaluated the subjects through the"Digital Intelligence software (doctor side)", and formulated the diet and exercise program according to the individual conditions of the subjects. | Procedure or surgery | Digital Intelligence Software Group |
Primary outcome
Body weight
Time frame: 48weeks
Absolute and relative changes from baseline in body weight
4 secondary outcomes
Fasting plasma glucose
Time frame: 48week
Liver MRI PDFF
Time frame: 48weeks
Liver FibroScan
Time frame: 48week
Body Mass Index (BMI)
Time frame: 48week
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 18 Nov 2025.
- Individual participant dataSharing planned: No. The study has not been completed
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Effect of SGLT2 Inhibitor on Metabolic-Dysfunction-Associated Fatty Liver Disease in Patients With Insulin Resistance
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Intelligence Software Intervention Group in people with MAFLD, run by The Affiliated Hospital of Hangzhou Normal University at 1 site in China.
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 5 inclusion and 34 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. 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 China. 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 junping shi, doctor's degree (+86 139 5712 1199, 20131004@hznu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 48weeks). 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 18 Nov 2025.