Body Composition and Fatty Liver Disease

Sponsor

Seoul National University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05695118

Collaborator

(none)

150

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Fatty Liver	Diagnostic Test: Non-contrast low-dose abdomen CT Diagnostic Test: Fibroscan Diagnostic Test: bioelectrical impedance analysis (BIA)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jan 31, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

relationship between body composition analysis result from CT and liver fat fraction [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 Outcome Measures

ratio of appropriate non-contrast low dose abdomen CT acquisition & analysis [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 [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) [6 month after CT acquisition]
agreement of visceral fat, subcutaneous fat, muscle amount between CT based body composition and Inbody test results

Other Outcome Measures

incidence of incidental finding [6 month after CT acquisition]
incidentally detected findings on low-dose abdomen CT

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Jeong Min Lee, MD, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeong Min Lee, Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT05695118

Other Study ID Numbers:

SNUH-2022-3238

First Posted:

Jan 23, 2023

Last Update Posted:

Jan 23, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jeong Min Lee, Professor, Seoul National University Hospital

Additional relevant MeSH terms:

Fatty Liver

Study Results

No Results Posted as of Jan 23, 2023