Actively Recruiting
A Multicenter, Randomized, Crossover Clinical Trial Study of Digital Intelligence Software in Patients With MAFLD
Led by The Affiliated Hospital of Hangzhou Normal University · Updated on 2025-11-18
2000
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Multicenter, Randomized, Crossover Clinical Trial Study of Digital Intelligence Software in Patients With MAFLD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years with a BMI of 24-35 kg/m8
- Confirmed diagnosis of metabolic associated fatty liver disease (MAFLD) by FibroScan4 or MRI-PDFF
- Willing and able to provide written informed consent and follow the study protocol
- If treated for Type 2 Diabetes Mellitus, must be on a stable medication regimen for at least 3 months before Day 0
- If taking medications with potential NASH-remitting effects, must be on a stable dose for at least 3 months before Day 0
You will not qualify if you...
- Evidence of cirrhosis (histological stage F4 or clinical equivalent)
- History of heavy alcohol use (>30 g/day for males, >20 g/day for females) for over 3 consecutive months within one year before screening
- Prior or planned solid organ transplantation (except corneal transplants)
- Planned bariatric surgery; prior bariatric surgery allowed only if weight stable within 10% for 3 months before screening
- Other chronic liver diseases including hepatitis B, hepatitis C, primary biliary cholangitis, autoimmune hepatitis, Wilson's disease, alpha-1 antitrypsin deficiency, or hereditary hemochromatosis
- History of Type 1 Diabetes Mellitus or uncontrolled Type 2 Diabetes Mellitus (HbA1c >9% or current insulin therapy)
- History of hepatic decompensation events
- Laboratory abnormalities at screening such as low platelets, low albumin, high INR, elevated liver enzymes, high bilirubin (except Gilbert's syndrome), low eGFR, low hemoglobin
- Uncontrolled thyroid dysfunction
- Documented HIV infection
- Known G6PD deficiency
- Significant cardiovascular history within one year before screening
- Malignancy diagnosis within past 2 years (except certain skin cancers)
- Severe comorbid respiratory, cardiac, cerebrovascular, hepatic, or renal conditions
- Active severe infection requiring IV antibiotics within 30 days before screening
- Major surgery within 30 days before screening
- Chronic use of medications that promote hepatic steatosis within 3 months before screening
- Current or planned treatment with radiation, chemotherapy, or immunomodulatory agents
- Use of investigational agents within 6 months before screening or prior participation in NASH/MAFLD clinical trials within 6 months
- Pregnancy or lactation
- Any other condition or circumstance that may compromise safety or study validity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hangzhou Normal University Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
J
junping shi, doctor's degree
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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