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

NCT06225713 | Recruiting DMC

• 1 other identifier: PARADISE-NAFLD
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Non-alcoholic Fatty Liver Disease; Focused ultrasound; Novel method

Outcome Measures

Primary Outcomes (1)

• Absolute Change in Liver Fat Content

  Absolute change in liver fat content assessed by magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) at 3-month compared with baseline

  From baseline to 3 months post-procedure

Secondary Outcomes (6)

• Relative Change in Liver Fat Content

  From baseline to 3 months post-procedure

• Proportion of MRI-PDFF Responders

  From baseline to 3 months post-procedure

• Change in Alanine Aminotransferase (ALT)

  From baseline to 3 months post-procedure

• Change in Concentration of Cytokeratin-18

  From baseline to 3 months post-procedure

• Change in Liver Stiffness Measurement and Controlled Attenuation Parameter

  From baseline to 3 months post-procedure

Other Outcomes (12)

• Chang in Fasting Lipid Profile

  From baseline to 3 months post-procedure

• Change in Concentration of Fasting Plasma Glucose (FPG)

  From baseline to 3 months post-procedure

• Change in Concentration of Fasting serum insulin (FINS)

  From baseline to 3 months post-procedure

Study Arms (2)

intervention group

EXPERIMENTAL

In intervention group, participants will receive the whole peri-renal fat modification therapy (including peri-renal fat ultrasonic measurement and localization, focused ultrasound treatment parameters setting and initiating)

Device: focused power ultrasound mediated inferior perirenal adipose tissue modification

sham-control group

SHAM COMPARATOR

In sham control group, participants will receive the sham control therapy (including peri-renal fat ultrasonic measurement and localization, focused ultrasound treatment parameters setting), however, without initiating the focused ultrasound equipment.

Device: sham-control group

Interventions

focused power ultrasound mediated inferior perirenal adipose tissue modification DEVICE

This novel focused power ultrasound is an externally delivered, completely noninvasive focused therapeutic ultrasound device. It is capable of focusing the resulting ultrasound beam to a small "cigar"-shaped volume and monitoring the temperature of the target area, which leads to the rapid elevation of the peri-renal adipose tissue temperature and the destruction of target tissue eventually.

intervention group

sham-control group DEVICE

Participants will receive the sham control therapy (including peri-renal fat ultrasonic measurement and localization, focused ultrasound treatment parameters setting), however, without initiating the focused ultrasound equipment.

sham-control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• The Affiliated Jiangning Hospital of Nanjing Medical University: collaborator
• Suzhou Municipal Hospital: collaborator

Study Sites (3)

The Affiliated Jiangning Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

JiangSu Province Hospital / The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Suzhou Municipal Hospital

Suzhou, Jiangsu, 215000, China

RECRUITING

Related Publications (3)

• Xu C, Ma Z, Wang Y, Liu X, Tao L, Zheng D, Guo X, Yang X. Visceral adiposity index as a predictor of NAFLD: A prospective study with 4-year follow-up. Liver Int. 2018 Dec;38(12):2294-2300. doi: 10.1111/liv.13941. Epub 2018 Sep 6.

  PMID: 30099825 BACKGROUND

• Petta S, Amato MC, Di Marco V, Camma C, Pizzolanti G, Barcellona MR, Cabibi D, Galluzzo A, Sinagra D, Giordano C, Craxi A. Visceral adiposity index is associated with significant fibrosis in patients with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2012 Jan;35(2):238-47. doi: 10.1111/j.1365-2036.2011.04929.x. Epub 2011 Nov 24.

  PMID: 22117531 BACKGROUND

• van der Poorten D, Milner KL, Hui J, Hodge A, Trenell MI, Kench JG, London R, Peduto T, Chisholm DJ, George J. Visceral fat: a key mediator of steatohepatitis in metabolic liver disease. Hepatology. 2008 Aug;48(2):449-57. doi: 10.1002/hep.22350.

  PMID: 18627003 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• shijing5499@jsph.org.cn Kong

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangqing Kong

CONTACT

+8613951610265; kongxq@njmu.edu.cn

Jing Shi

CONTACT

+8615051872305; shijing5499@jsph.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The masking range includes participants, most researchers (including the study leader; subjects screening researchers; follow-up researchers; sonographers, MR scanners, members of the clinical endpoint identification committee, and etc.) except for the study statistical analysts and the therapy operators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiology

Model Details: This is a randomized, blinded, and sham-control study. The ratio of the intervention group versus sham-control group is 1:1

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 26, 2024
• Study Start: February 2, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)