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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Body weight
Timeframe: 48weeks
Trial details
NCT IDNCT07233486
SponsorThe Affiliated Hospital of Hangzhou Normal University
. 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: