Body Composition and Fatty Liver Disease

Not Applicable

Active, not recruiting

• Conditions: Fatty Liver
• Interventions: Diagnostic Test: Non-contrast low-dose abdomen CT; Diagnostic Test: Fibroscan; Diagnostic Test: bioelectrical impedance analysis (BIA)

• Registration Number: NCT05695118
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-24
• Study First Submitted QC: 2023-01-14
• Study First Posted: 2023-01-23
• Study Start: 2023-02-10
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-18
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
non-contrast low-dose abdomen CT	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).
non-contrast low-dose abdomen CT	bioelectrical impedance analysis (BIA)	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).
non-contrast low-dose abdomen CT	Fibroscan	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of