Body Composition and Fatty Liver Disease

NCT ID: NCT05695118

Last Updated: 2023-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-10

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Fatty Liver

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Non-contrast low-dose abdomen CT

Intervention Type DIAGNOSTIC_TEST

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

Fibroscan

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Non-contrast low-dose abdomen CT

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

Intervention Type 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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Inbody test (commercial name)

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong Min Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Min Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUH-2022-3238

Identifier Type: -

Identifier Source: org_study_id

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