Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Non-Alcoholic Fatty Liver Disease (PARADISE-NAFLD)

Summary

This randomized, blinded, sham-control trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for non-alcoholic fatty liver disease.

Eligibility

Inclusion Criteria:

* 18 years or older at the time of screening.
* Total liver fat content ≥10% measured by MRI-PDFF.
* Body mass index (BMI) ≥ 25 kg/m\^2.
* The anteroposterior, transverse and axial diameters of inferior perirenal fat pad measured by ultrasound should be at least 20mm.
* Participants should be willing to sign the informed consent form of the study.

Exclusion Criteria:

* History of significant alcohol consumption (significant alcohol consumption was defined as more than 140 g/week in females and more than 210 g/week in males in the last 12months before screening, on average).
* Secondary factors causing hepatic steatosis, including viral hepatitis C, autoimmune hepatitis, total parenteral nutrition, celiac disease, Wilson's disease, hypothyroidism, hereditary hemochromatosis, drug factors (amiodarone, glucocorticoids, methotrexate, tamoxifen), etc.
* Complicating other chronic liver diseases, mainly including viral hepatitis, cholestatic liver disease, drug-induced liver injury, etc.
* Weight change \>10% in the past 3 months.
* Clinical or pathological diagnosis of cirrhosis.
* NAFLD treatment drugs (such as vitamin E, obecholic acid, thiazolidinediones, etc.) were used within 6 months before enrollment.
* History of bariatric surgery.
* History of kidney and/or surrounding tissue surgery.
* Waist skin infection.
* Urinary stones and/or hematuria (positive for gross hematuria or occult blood).
* Unstable cardiovascular diseases: (1) Myocardial infarction, unstable angina pectoris or cerebrovascular accident occurred in the last 6 months. (2) Persistent atrial fibrillation without anticoagulation. (3) Severe structural heart disease (including valvular heart disease, cardiomyopathy). (4) second degree and above atrioventricular block and/or sick sinus syndrome. (5) Uncontrolled hypertension.
* Type 1 diabetes or uncontrolled hyperglycemia (HBA1c ≥ 9.5%).
* Participants with untreated tumors.
* Laboratory screening results include one or more of the following: (1) Neutrophil absolute value \<1.0x10\^9/L. (2) Platelet count \<100x10\^9/L. (3) Hemoglobin \<100g/L. (4) Albumin \<35g/L. (5) International standard value \>1.5. (6) Total bilirubin \>1.5 times the upper limit of normal value. (7) The estimated glomerular filtration rate was \<60ml/ (minx1.73m\^2).
* Participants who are pregnant, breastfeeding or trying to conceive.
* Any contraindication or inability to obtain an MRI.
* Participants who were unable to follow up.
* Any other situation that the investigator considers to be detrimental to the patient's health, hindering the completion of the study, or interfering with the results of the study.

Conditions2

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