Body Composition and Fatty Liver Disease

NCT05695118 | Unknown DMC

• 1 other identifier: SNUH-2022-3238
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatty Liver

Keywords

CT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• ratio of appropriate non-contrast low dose abdomen CT acquisition & analysis

  6 month after CT acquisition

• relationship between body composition analysis result from CT and hepatic fibrosis

  6 month after CT acquisition

• agreement between body composition analysis result from CT and bioelectrical impedance analysis (Inbody test)

  6 month after CT acquisition

Other Outcomes (1)

• incidence of incidental finding

  6 month after CT acquisition

Study Arms (1)

non-contrast low-dose abdomen CT

EXPERIMENTAL

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; Diagnostic Test: Fibroscan; Diagnostic Test: bioelectrical impedance analysis (BIA)

Interventions

Non-contrast low-dose abdomen CT DIAGNOSTIC_TEST

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

non-contrast low-dose abdomen CT

Fibroscan DIAGNOSTIC_TEST

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

non-contrast low-dose abdomen CT

bioelectrical impedance analysis (BIA) DIAGNOSTIC_TEST

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

Also known as: Inbody test (commercial name)

non-contrast low-dose abdomen CT

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Jeong Min Lee, MD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 24, 2022
• First Posted: January 23, 2023
• Study Start: February 10, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)