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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05695118
Enrollment
150
Registered
2023-01-23
Start date
2023-02-10
Completion date
2024-12-31
Last updated
2023-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Liver

Keywords

CT

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.

Interventions

DIAGNOSTIC_TESTNon-contrast low-dose abdomen CT

target effective dose: \< 1.5 mSv It is performed twice in 6-month interval.

DIAGNOSTIC_TESTFibroscan

Fibroscan is performed within a week of low-dose CT. It is used as a reference standard of hepatic fibrosis and steatosis.

BIA test is performed on the same day of low-dose CT. Commercially available model (Inbody 270) is used.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
relationship between body composition analysis result from CT and liver fat fraction6 month after CT acquisitionrelationship 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

MeasureTime frameDescription
ratio of appropriate non-contrast low dose abdomen CT acquisition & analysis6 month after CT acquisitionNumber 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 fibrosis6 month after CT acquisitionrelationship 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 acquisitionagreement of visceral fat, subcutaneous fat, muscle amount between CT based body composition and Inbody test results

Other

MeasureTime frameDescription
incidence of incidental finding6 month after CT acquisitionincidentally detected findings on low-dose abdomen CT

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026