A Multicenter, Randomized, Crossover Clinical Trial Study of Digital Intelligence Software in Pat… (NCT07233486) | Clinical Trial Compass
RecruitingNot Applicable
A Multicenter, Randomized, Crossover Clinical Trial Study of Digital Intelligence Software in Patients With MAFLD
China2,000 participantsStarted 2024-08-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Body weight
Timeframe: 48weeks
Trial details
NCT IDNCT07233486
SponsorThe Affiliated Hospital of Hangzhou Normal University
. 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.