A Multicenter, Randomized, Crossover Clinical Trial Study of Digital Intelligence Software
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 charact
| Condition(s) | MAFLD |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 | Inclusion Criteria 1. Adult patients aged 18-65 years with a BMI of 24-35 kg/m². 2. Confirmed diagnosis of Metabolic-associated Fatty Liver Disease (MAFLD), defined by a FibroScan® result \> 248 dB/m or an MRI-PDFF \> 5%. 3. 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. 4. 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. 5. 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 Crite |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | The Affiliated Hospital of Hangzhou Normal University |
| Locations | Hangzhou, Zhejiang, China |
| Start date | 2024-08-01 |
| NCT ID | NCT07233486 |
| Official listing | https://clinicaltrials.gov/study/NCT07233486 |