Fatty LiverNCT05695118
Body Composition and Fatty Liver Disease
A study testing Non-contrast low-dose abdomen CT, Fibroscan and bioelectrical impedance analysis (BIA) in people with Fatty Liver, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Fatty Liver
- What is being tested?
- Non-contrast low-dose abdomen CT, Fibroscan and bioelectrical impedance analysis (BIA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Feb 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Prognostic Correlation Between Body Composition Analysis and Fatty Liver Progression in Patients With Fatty Liver Using Low-dose CT
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
- Being tested
- Non-contrast low-dose abdomen CT, Fibroscan, bioelectrical impedance analysis (BIA)
- Keywords
- CT
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-contrast low-dose abdomen CTDiagnostic test
target effective dose: < 1.5 mSv It is performed twice in 6-month interval.
FibroscanDiagnostic 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)Diagnostic test
Also called Inbody test (commercial name)
BIA test is performed on the same day of low-dose CT. Commercially available model (Inbody 270) is used.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Non-contrast low-dose abdomen CT; Diagnostic Test: Fibroscan; Diagnostic Test: bioelectrical impedance analysis (BIA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 month after CT acquisition
Secondary outcomes (3)
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
Measured: 6 month after CT acquisition
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
Measured: 6 month after CT acquisition
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
Measured: 6 month after CT acquisition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start10 Feb 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
- Investigators
- Jeong Min Lee, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695118
- Sponsor's protocol ID
- SNUH-2022-3238
- Status last verified
- Aug 2023
- First submitted
- 24 Dec 2022
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Prognostic Correlation Between Body Composition Analysis and Fatty Liver Progression in Patients With Fatty Liver Using Low-dose CT
- ClinicalTrials.gov ID
- NCT05695118
- Acronym / sponsor ID
- SNUH-2022-3238
- Conditions
- Fatty Liver
- Keywords
- CT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-contrast low-dose abdomen CT | Experimental | Diagnostic Test: Non-contrast low-dose abdomen CT, Diagnostic Test: Fibroscan, Diagnostic Test: 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). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-contrast low-dose abdomen CTtarget effective dose: < 1.5 mSv It is performed twice in 6-month interval. | Diagnostic test | non-contrast low-dose abdomen CT |
| FibroscanFibroscan is performed within a week of low-dose CT. It is used as a reference standard of hepatic fibrosis and steatosis. | Diagnostic test | non-contrast low-dose abdomen CT |
| bioelectrical impedance analysis (BIA)Also: Inbody test (commercial name)BIA test is performed on the same day of low-dose CT. Commercially available model (Inbody 270) is used. | Diagnostic test | non-contrast low-dose abdomen CT |
Primary outcome
relationship between body composition analysis result from CT and liver fat fraction
Time frame: 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
3 secondary outcomes
ratio of appropriate non-contrast low dose abdomen CT acquisition & analysis
Time frame: 6 month after CT acquisition
relationship between body composition analysis result from CT and hepatic fibrosis
Time frame: 6 month after CT acquisition
agreement between body composition analysis result from CT and bioelectrical impedance analysis (Inbody test)
Time frame: 6 month after CT acquisition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong Min Lee, MD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-contrast low-dose abdomen CT, Fibroscan and bioelectrical impedance analysis (BIA) in people with Fatty Liver, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relationship between body composition analysis result from CT and liver fat fraction (time frame: 6 month after CT acquisition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.