Body Composition and Fatty Liver Disease

Analysis of the Prognostic Correlation Between Body Composition Analysis and Fatty Liver Progression in Patients With Fatty Liver Using Low-dose CT

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Fatty Liver
• Intervention / Treatment: Diagnostic test: Non-contrast low-dose abdomen CT; Diagnostic test: Fibroscan; Diagnostic test: bioelectrical impedance analysis (BIA)

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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).

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.; Other Names: Inbody test (commercial name)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
relationship between body composition analysis result from CT and liver fat fraction	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	6 month after CT acquisition

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ratio of appropriate non-contrast low dose abdomen CT acquisition & analysis	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	6 month after CT acquisition
relationship between body composition analysis result from CT and hepatic fibrosis	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	6 month after CT acquisition
agreement between body composition analysis result from CT and bioelectrical impedance analysis (Inbody test)	agreement of visceral fat, subcutaneous fat, muscle amount between CT based body composition and Inbody test results	6 month after CT acquisition

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of incidental finding	incidentally detected findings on low-dose abdomen CT	6 month after CT acquisition

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Jeong Min Lee, MD, professor

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 24, 2022
• First Submitted That Met QC Criteria: January 14, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: CT
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: SNUH-2022-3238

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No