Body Composition and Fatty Liver Disease

Fatty Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05695118
• Other study ID #: SNUH-2022-3238
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 10, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver

Intervention

Diagnostic Test:
• Non-contrast low-dose abdomen CT
target effective dose: < 1.5 mSv It is performed twice in 6-month interval.
• Fibroscan
Fibroscan is performed within a week of low-dose CT. It is used as a reference standard of hepatic fibrosis and steatosis.
• bioelectrical impedance analysis (BIA)
BIA test is performed on the same day of low-dose CT. Commercially available model (Inbody 270) is used.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	incidence of incidental finding	incidentally detected findings on low-dose abdomen CT	6 month after CT acquisition
Primary	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	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
Secondary	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
Secondary	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