Back to resultsBody Composition and Fatty Liver Disease
Primary Purpose
Fatty Liver
Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Non-contrast low-dose abdomen CT
Fibroscan
bioelectrical impedance analysis (BIA)
Sponsored by
About this trial
This is an interventional diagnostic trial for Fatty Liver focused on measuring CT
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
non-contrast low-dose abdomen CT
Arm Description
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).
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
Full Information
NCT ID
NCT05695118
First Posted
December 24, 2022
Last Updated
August 16, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05695118
Brief Title
Body Composition and Fatty Liver Disease
Official Title
Analysis of the Prognostic Correlation Between Body Composition Analysis and Fatty Liver Progression in Patients With Fatty Liver Using Low-dose CT
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver
Keywords
CT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
non-contrast low-dose abdomen CT
Arm Type
Experimental
Arm Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
Non-contrast low-dose abdomen CT
Intervention Description
target effective dose: < 1.5 mSv It is performed twice in 6-month interval.
Intervention Type
Diagnostic Test
Intervention Name(s)
Fibroscan
Intervention Description
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
Intervention Name(s)
bioelectrical impedance analysis (BIA)
Other Intervention Name(s)
Inbody test (commercial name)
Intervention Description
BIA test is performed on the same day of low-dose CT. Commercially available model (Inbody 270) is used.
Primary Outcome Measure Information:
Title
relationship between body composition analysis result from CT and liver fat fraction
Description
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
Time Frame
6 month after CT acquisition
Secondary Outcome Measure Information:
Title
ratio of appropriate non-contrast low dose abdomen CT acquisition & analysis
Description
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
Time Frame
6 month after CT acquisition
Title
relationship between body composition analysis result from CT and hepatic fibrosis
Description
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
Time Frame
6 month after CT acquisition
Title
agreement between body composition analysis result from CT and bioelectrical impedance analysis (Inbody test)
Description
agreement of visceral fat, subcutaneous fat, muscle amount between CT based body composition and Inbody test results
Time Frame
6 month after CT acquisition
Other Pre-specified Outcome Measures:
Title
incidence of incidental finding
Description
incidentally detected findings on low-dose abdomen CT
Time Frame
6 month after CT acquisition
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, MD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Body Composition and Fatty Liver Disease
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