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.
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.
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.
Crossover
Digital Intelligence Software Intervention Group
Procedure/SurgeryStudy 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.
Body weight
Absolute and relative changes from baseline in body weight
Fasting plasma glucose
Compare the changes in fasting blood glucose before and after treatment
Liver MRI PDFF
To evaluate the effects of weight and glucose reduction interventions on proton density fat fraction (MRI-PDFF) in patients with MAFLD
Liver FibroScan
liver fat attenuation parameter (CAP) , liver stiffness value (LSM)
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)
Biochemical indicators
Serum levels of aspartate aminotransferase (AST U/L) and alanine aminotransferase (ALT U/L)
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