Body Composition and Fatty Liver Disease

Overview

This study investigates relationship between fatty liver prognosis and body composition analysis result based on non-contrast low dose CT in patients with fatty liver disease.

Full Title of Study: “Analysis of the Prognostic Correlation Between Body Composition Analysis and Fatty Liver Progression in Patients With Fatty Liver Using Low-dose CT”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2023

Interventions

  • Diagnostic Test: Non-contrast low-dose abdomen CT
    • target effective dose: < 1.5 mSv It is performed twice in 6-month interval.
  • Diagnostic Test: Fibroscan
    • Fibroscan is performed within a week of low-dose CT. It is used as a reference standard of hepatic fibrosis and steatosis.
  • Diagnostic Test: bioelectrical impedance analysis (BIA)
    • BIA test is performed on the same day of low-dose CT. Commercially available model (Inbody 270) is used.

Arms, Groups and Cohorts

  • Experimental: non-contrast low-dose abdomen CT
    • non-contrast low-dose abdomen CT (target effective dose: < 1.5 mSv). CT based body composition analysis is performedd with commercially available automatic segmentation software (DeepCatch, Medical IP, South Korea).

Clinical Trial Outcome Measures

Primary Measures

  • relationship between body composition analysis result from CT and liver fat fraction
    • Time Frame: 6 month after CT acquisition
    • relationship between visceral fat volume fraction (obtained from CT analysis using automatic body segmentation, unitless (visceral fat fraction = visceral fat volume/total body volume)) and CAP value of fibroscan

Secondary Measures

  • ratio of appropriate non-contrast low dose abdomen CT acquisition & analysis
    • Time Frame: 6 month after CT acquisition
    • Number of CT scan with effective dose < 1.5 mSv AND successful automatic body composition analysis (without manual editing) divided by total number of CT scan
  • relationship between body composition analysis result from CT and hepatic fibrosis
    • Time Frame: 6 month after CT acquisition
    • relationship between visceral fat volume fraction (CT analysis using automatic body segmentation, unitless (visceral fat fraction = visceral fat volume/total body volume)) and liver stiffness value of fibroscan
  • agreement between body composition analysis result from CT and bioelectrical impedance analysis (Inbody test)
    • Time Frame: 6 month after CT acquisition
    • agreement of visceral fat, subcutaneous fat, muscle amount between CT based body composition and Inbody test results

Participating in This Clinical Trial

Inclusion Criteria

  • metabolic dysfunction-associated fatty liver disease (fatty liver with overweight/obesity, or type II DM or other metabolic dysfunction) – or non-alcoholic fatty liver disease with liver function test abnormality – signed informed consent Exclusion Criteria:

  • chronic hepatitis B or C – other disease related to fatty liver such as glycogen storage disease, lipodystrophy, familial combined hyperlipidemia, hypobetalipoproteinemia, Weber-Christian syndrome or abetalipoproteinemia – on medication related to hepatic steatosis (tamoxifen, steroid, valproic acid, methotrexate, amiodarone) – diabetes after pancreatectomy – history of total parenteral nutrition in 6 months – pregnancy or nursing mother

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jeong Min Lee, Professor – Seoul National University Hospital
  • Overall Official(s)
    • Jeong Min Lee, MD, Principal Investigator, Professor
  • Overall Contact(s)
    • Hyuna Jung, 82-2-2072-4177, jha5375@snu.ac.kr

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