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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.