metabolic dysfunction-associated steatotic liver disease
Conditions
Interventions
Intervention group:Low-intensity ultrasound stimulation of the liver region guided by external body , at an intensity not exceeding the FDA safety threshold of 720 mW/cm^2 for ultrasound applied to th
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–60 years, male or female; 2. Meet the diagnostic criteria for MASLD: imaging evidence of hepatic steatosis, presence of metabolic dysfunction-related features, and exclusion of other major causes of steatotic liver disease; 3.Confirmed by MRI-PDFF at enrollment: baseline (end of stabilization period) MRI-PDFF >=8%; 4. Relatively stable body weight during the stabilization period (weight change <=3% over 4 weeks), willingness to maintain existing diet and exercise habits as required, completion of weekly weight reporting and diet/exercise log (once/week) during the 4-week stabilization period, and ability to complete at least two effective contacts (including one telephone confirmation) to ensure compliance with follow-up and key assessments. No history of bariatric surgery or use of weight-loss medications within the past 6 months; 5.No definite chronic liver disease attributable to other etiologies (see exclusion criteria for details); 6.Able to tolerate MRI, ultrasound, and other examinations, and complete follow-up visits; 7.Voluntary participation with signed informed consent from the subject or their legal guardian, and ability to cooperate with all study-related examinations during the clinical trial.
Exclusion criteria
Exclusion criteria: 1. Clinically diagnosed with alcohol-related liver disease; 2. History of other confirmed chronic liver diseases: viral hepatitis, autoimmune liver disease, cholestatic liver disease, drug-induced liver injury, inherited metabolic liver disease, etc.; 3. Imaging or clinical evidence of decompensated cirrhosis (ascites, bleeding from esophageal varices, hepatic encephalopathy, etc.); 4. History of liver transplantation or hepatocellular carcinoma; 5. Contraindications to MRI or severe claustrophobia; 6. Unstable cardiovascular or cerebrovascular disease, or deemed unsuitable for participation by the investigator; 7. Pregnancy, lactation, or plans to become pregnant during the study period; 8. Presence of implants or special conditions in the thoracic or abdominal region that may significantly affect ultrasound transmission or safety, and deemed unsuitable after evaluation; 9. BMI > 40 kg/m² and inability to obtain a stable acoustic window or secure transducer placement; 10. Concurrent severe psychiatric disorders or significant lack of compliance; 11. Concurrent severe cardiopulmonary or renal insufficiency, active malignant tumors, etc.; 12. Concurrent participation in other clinical trials that may influence the assessment of the primary endpoint.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRI-PDFF; | — |
Secondary
| Measure | Time frame |
|---|---|
| liver stiffness measurement;Controlled Attenuation Parameter;Liver Function Tests;Body weight;Body mass index;Blood glucose;Blood lipid profile;Glycosylated Hemoglobin, Type A1C;Fibrosis 4 Score;Nonalcoholic Fatty Liver Disease Fibrosis Score;waist circumference; | — |
Countries
China
Contacts
Public ContactZheng yuanyi
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed