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

ConditionMAFLD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe Affiliated Hospital of Hangzhou Normal University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Digital Intelligence Software Intervention Group

Treatment groups

2,000 Participants
are divided into 2 treatment groups