Focused ultrasound treatment for non-alcoholic fatty liver disease
Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Non-Alcoholic Fatty Liver Disease: a Randomized Controlled Trial (PARADISE-NAFLD)
This study is testing a new ultrasound treatment to see if it can help reduce liver fat and improve liver health in people with non-alcoholic fatty liver disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 3 sites (Nanjing, Jiangsu and 2 other locations) |
| Trial ID | NCT06225713 on ClinicalTrials.gov |
What this trial studies
This randomized, blinded, sham-controlled trial evaluates the efficacy and safety of a novel focused power ultrasound technique aimed at modifying inferior perirenal adipose tissue in patients with non-alcoholic fatty liver disease (NAFLD). The study builds on previous findings that suggest that modifying peri-renal fat can impact liver health by reducing toxic free fatty acids that contribute to NAFLD. Participants will be randomly assigned to receive either the ultrasound treatment or a sham procedure, and their liver fat content will be monitored using MRI-PDFF. The goal is to determine if this innovative approach can effectively reduce liver fat and improve overall liver function.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a body mass index of 25 kg/m² or higher and liver fat content of 10% or more.
Not a fit: Patients with significant alcohol consumption or secondary factors causing hepatic steatosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for patients with non-alcoholic fatty liver disease, potentially improving liver health and reducing associated complications.
How similar studies have performed: While this approach is novel, preliminary studies have shown feasibility and safety, indicating potential for success in larger trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Nanjing, Jiangsu and 2 other locations
- The Affiliated Jiangning Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
- JiangSu Province Hospital / The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
- Suzhou Municipal Hospital — Suzhou, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: shijing5499@jsph.org.cn Kong — The First Affiliated Hospital with Nanjing Medical University
- Study coordinator: Xiangqing Kong
- Email: kongxq@njmu.edu.cn
- Phone: +8613951610265
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.