Focused power ultrasound mediated modification of perirenal adipose tissue for managing non-alcoholic fatty liver disease: a pilot study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300068192

Enrollment

Unknown

Registered

2023-02-09

Start date

2023-02-15

Completion date

Unknown

Last updated

2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic fatty liver disease

Interventions

Treatment group:Perirenal adipose tissue modification therapy

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age = 18 years 2.Liver fat content in the liver = 10% (measured by MRI-PDFF) 3.Body mass index (BMI) = 25 kg/m^2 4.The minimum perirenal fat volume of either side > 8000mm^3 (measured by ultrasound) 5.Provision of written informed consent

Exclusion criteria

Exclusion criteria: 1.History of excessive alcohol consumption (alcohol intake > 210 g/week for men and > 140 g/week for women in the past 12 months) 2.Secondary factors causing hepatic steatosis, such as viral hepatitis C, autoimmune hepatitis, total parenteral nutrition, celiac disease, Wilson's disease, hypothyroidism, hereditary hemochromatosis, drug factors (amiodarone, glucocorticoids, methotrexate, tamoxifen), etc. 3.Coexisting with other chronic liver diseases, such as viral hepatitis, cholestatic liver disease, drug induced liver injury 4.Weight change > 5% in the past 6 months 5.Clinical or pathological diagnosis of cirrhosis 6.NAFLD treatment drugs (e.g., vitamin E, obecholic acid, thiazolidinediones, etc.) were used within 3 months before enrollment 7.Previous bariatric surgery 8.History of renal and/or peripheral tissue surgery 9.Waist skin infection 10.Urolithiasis and/or hematuria (positive for gross hematuria or occult blood) 11.Unstable cardiovascular disease: (1)Myocardial infarction, unstable angina pectoris or cerebrovascular accident 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 (5)Uncontrolled hypertension 12.Type 1 diabetes mellitus or uncontrolled hyperglycemia (HBA1c =9.5%) 13.Patients with untreated tumors 14.Laboratory screening results include one or more of the following: (1)Neutrophil absolute value 1.5 (6)Total bilirubin > 1.5 times the upper limit of normal (7)Estimated glomerular filtration rate < 60ml/ (min×1.73m^2) 15.Woman who is pregnant,lactating or preparing for pregnancy 16.Unable to complete MR Examination 17.Patients who are unable to complete the follow-up visit 18.Any other condition possibly harmimg the patient's health, hindering the completion of the study, or interfering with the results of the study

Design outcomes

Primary

Measure	Time frame
Liver fat content;	—

Secondary

Measure	Time frame
Cytokeratin 18;Enhance liver fibrosis score;Alanine transaminase;Liver stiffness measurement;Controlled attenuation parameter;	—

Countries

China

Contacts

Public ContactXiangqing Kong

Suzhou Municipal Hospital

kongxq@njmu.edu.cn+86 13951610265

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026