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.
Visceral adiposity is closely related to the incidence of non-alcoholic fatty liver disease (NAFLD), and it is also directly associated with liver inflammation and fibrosis. Visceral adiposity, via its unique location and enhanced lipolytic activity, releases toxic free fatty acids, which are delivered in high concentrations directly to the liver and lead to the accumulation and storage of hepatic fat. Furthermore, it has been recognized as an important endocrine organ, and a variety of factors secreted by visceral adiposity may lead to an increased risk of NAFLD. Peri-renal fat is a special type of visceral adiposity which is different from other type of visceral fat in histology, physiology, and functions. The position of peri-renal fat is more stable than other visceral fat. The investigators found that prophylactic perirenal adipose tissue ablation can prevent the development of NAFLD in mice induced by high fat diets, and also this novel focused power ultrasound can rapidly and efficiently promote the peri-renal adipose tissue fibrosis in the model of swine. Moreover, the investigators performed a single arm, small sample study to investigate the feasibility of the novel focused power ultrasound to modify the inferior peri-renal adipose tissue in NAFLD participants, showing that this kind of method was feasible and safe. In this study, the investigators aim to further evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for NAFLD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
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.
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.
The Affiliated Jiangning Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGJiangSu Province Hospital / The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGSuzhou Municipal Hospital
Suzhou, Jiangsu, China
RECRUITINGAbsolute 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
Time frame: From baseline to 3 months post-procedure
Relative Change in Liver Fat Content
Relative change in liver fat content assessed by MRI-PDFF at 3-month compared with baseline
Time frame: From baseline to 3 months post-procedure
Proportion of MRI-PDFF Responders
Proportion of MRI-PDFF responders in two groups at 3-month of treatment. MRI-PDFF responder is defined as a ≥30% relative reduction in MRI-PDFF between baseline and end of treatment
Time frame: From baseline to 3 months post-procedure
Change in Alanine Aminotransferase (ALT)
ALT is increased with liver damage. The blood levels of ALT are used to detect liver injury.
Time frame: From baseline to 3 months post-procedure
Change in Concentration of Cytokeratin-18
Change in concentration of cytokeratin-18 in two groups at 3-month of treatment
Time frame: From baseline to 3 months post-procedure
Change in Liver Stiffness Measurement and Controlled Attenuation Parameter
Change in liver stiffness measurement and controlled attenuation parameter measured by transient elastography at 3-month of treatment
Time frame: From baseline to 3 months post-procedure
Change in Enhanced Liver Fibrosis Test
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The markers of fibrosis assessed in this test comprised hyaluronic acid, tissue inhibitor of metalloproteinase 1 and procollagen III N-terminal peptide; these are elevated during fibrogenesis as a result of activation of the hepatic stellate cell.
Time frame: From baseline to 3 months post-procedure