A Multicenter, Randomized, Crossover Clinical Trial Study of Digital Intelligence Software in Patients With MAFLD

NCT07233486 | Recruiting

• 2 other identifiers: 2025(E2)-HS-0532023ZD0508704
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Body weight

  Absolute and relative changes from baseline in body weight

  48weeks

Secondary Outcomes (4)

• Fasting plasma glucose

  48week

• Liver MRI PDFF

  48weeks

• Liver FibroScan

  48week

• Body Mass Index (BMI)

  48week

Other Outcomes (1)

• Biochemical indicators

  48week

Study Arms (2)

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.

Procedure: Digital Intelligence Software Intervention Group

Interventions

Digital Intelligence Software Intervention Group PROCEDURE

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.

Digital Intelligence Software Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• The Affiliated Hospital of Hangzhou Normal University: lead

Study Sites (1)

Hangzhou Normal University Hospital

Hangzhou, Zhejiang, China

RECRUITING

Central Study Contacts

junping shi, doctor's degree

CONTACT

+86 139 5712 1199; 20131004@hznu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: November 18, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): August 30, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)