Non-Alcoholic Fatty Liver DiseaseNCT04989062
Predicting Obesity Consequences Using Body Measure and Urine Metabolomics
An observational study of Non-Alcoholic Fatty Liver Disease and Body Composition, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This is a prospective observational study which will recruit up to 1200 participants over a two-year period to investigate whether non-invasive methods such as bioelectrical impedance analysis parameters and urine metabolic profile are predictors for pediatric non-alcoholic liver disease. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Body Composition, Electric Impedance
- What is being tested?
- Fibroscan, Bioelectrical impedance analysis and Urine unclear magnetic resonance metabolomics
- How many people
- 1,200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2020to 31 Jul 2022
- Phase
- Observational
- 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 6 to 13 years
- All sexes
- Child
Study population: Participants in the Year 1 to Year 6 of primary school (aged 6-13 years) without liver disease will be recruited for body measure, urine sampling and Fibroscan test.
Who may be able to join
- Apparently healthy male or female children
- Students in Year 1 to Year 6 of primary schools
Who cannot join
- Unknown liver disease
- Metal implant or splint
- Pacemaker implantation
- Limb defect or injury
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Chiayi City, 61363
Li-Wen Lee, MD, PhD, +886 5 3621 000 ext. 2382, m4572@cgmh.org.tw
About this study
This is a prospective observational study which will recruit up to 1200 participants over a two-year period to investigate whether non-invasive methods such as bioelectrical impedance analysis parameters and urine metabolic profile are predictors for pediatric non-alcoholic liver disease.
Read the detailed description
Obesity is associated with non-alcoholic fatty liver in children. Currently, body mass index is used for stratification risk for non-alcoholic fatty liver disease in children. However, body mass index represents the adjusted weight status for height and may not be a perfect surrogate for body fatness. This study assumes that a combination of body measures including parameters of bioelectrical impedance analysis and hand grip strength may better represented body fatness and healthy status than body mass index. Moreover, non-alcoholic fatty liver disease is strongly associated with the metabolic syndrome and non-invasive urine metabolic profile may be used to predict the disease status. The aim of this study will be to develop non-invasive methods using body measures and urine metabolic profile to predict pediatric fatty liver disease.
This study will recruit 1200 apparently healthy children at Year 1 to Year 6 in the primary schools in Taiwan within a two-year period. A series of tests including body measures, bioelectrical impedance analysis, hand grip strength and urine metabolomics by nuclear magnetic resonance will be performed in each participant. These data will be used as features to predict the results of Fibroscan test.
- Being tested
- Fibroscan, Bioelectrical impedance analysis, Urine unclear magnetic resonance metabolomics, Hand grip strength
- Keywords
- Non-Alcoholic Fatty Liver Disease, Body Composition, Electric Impedance
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroscanDiagnostic test
Controlled attenuation parameter and liver stiffness measurement are measured.
Bioelectrical impedance analysisDiagnostic test
Body composition measures including fat mass, fat-free mass, percentage body fat in total body and body segments are obtained.
Urine unclear magnetic resonance metabolomicsDiagnostic test
Metabolites in the urine are estimated by 600 MHz nuclear magnetic resonance.
Hand grip strengthDiagnostic test
Hand grip strength in both hands is measured by hand-held dynamometer.
| Study group | Role | What they receive |
|---|---|---|
| Healthy children | Apparently healthy children at Year 1 to Year 6 in the primary school in Taiwan. Exclusion criteria are children with metal implant or splint, pacemaker implantation, limb defect or injury and pregnant. Receives: Diagnostic Test: Fibroscan; Diagnostic Test: Bioelectrical impedance analysis; Diagnostic Test: Urine unclear magnetic resonance metabolomics; Diagnostic Test: Hand grip strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between bioelectrical impedance analysis parameters and the degree of fatty liver
Correlation body composition parameters by bioelectrical impedance analysis and controlled attenuation parameter by Fibroscan
Measured: 24 months
Secondary outcomes (1)
Correlation between urine metabolites and the degree of fatty liver
Correlation between urine metabolites by nuclear magnetic resonance and controlled attenuation value parameter by Fibroscan
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Aug 2020
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Li-Wen Lee, Chang Gung Memorial Hospital
- Investigators
- Li-Wen Lee, MD, PhD, Principal investigator, Chang Gung Memorial Hospital, Chiayi, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989062
- Sponsor's protocol ID
- 201901889A3
- Status last verified
- Jul 2021
- First submitted
- 11 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Obesity Consequences Using Body Measure and Urine Metabolomics
- ClinicalTrials.gov ID
- NCT04989062
- Acronym / sponsor ID
- 201901889A3
- Keywords
- Non-Alcoholic Fatty Liver Disease, Body Composition, Electric Impedance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 4 Aug 2021 (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 is a prospective observational study which will recruit up to 1200 participants over a two-year period to investigate whether non-invasive methods such as bioelectrical impedance analysis parameters and urine metabolic profile are predictors for pediatric non-alcoholic liver disease.
Detailed description
Obesity is associated with non-alcoholic fatty liver in children. Currently, body mass index is used for stratification risk for non-alcoholic fatty liver disease in children. However, body mass index represents the adjusted weight status for height and may not be a perfect surrogate for body fatness. This study assumes that a combination of body measures including parameters of bioelectrical impedance analysis and hand grip strength may better represented body fatness and healthy status than body mass index. Moreover, non-alcoholic fatty liver disease is strongly associated with the metabolic syndrome and non-invasive urine metabolic profile may be used to predict the disease status. The aim of this study will be to develop non-invasive methods using body measures and urine metabolic profile to predict pediatric fatty liver disease.
This study will recruit 1200 apparently healthy children at Year 1 to Year 6 in the primary schools in Taiwan within a two-year period. A series of tests including body measures, bioelectrical impedance analysis, hand grip strength and urine metabolomics by nuclear magnetic resonance will be performed in each participant. These data will be used as features to predict the results of Fibroscan test.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy children | – | Diagnostic Test: Fibroscan, Diagnostic Test: Bioelectrical impedance analysis, Diagnostic Test: Urine unclear magnetic resonance metabolomics, Diagnostic Test: Hand grip strengthApparently healthy children at Year 1 to Year 6 in the primary school in Taiwan. Exclusion criteria are children with metal implant or splint, pacemaker implantation, limb defect or injury and pregnant. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Age groups
- Child
- Study population
- Participants in the Year 1 to Year 6 of primary school (aged 6-13 years) without liver disease will be recruited for body measure, urine sampling and Fibroscan test.
Key inclusion criteria (2 listed)
- Apparently healthy male or female children
- Students in Year 1 to Year 6 of primary schools
Key exclusion criteria (5 listed)
- Unknown liver disease
- Metal implant or splint
- Pacemaker implantation
- Limb defect or injury
- Pregnancy
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 |
|---|---|---|
| FibroscanControlled attenuation parameter and liver stiffness measurement are measured. | Diagnostic test | Healthy children |
| Bioelectrical impedance analysisBody composition measures including fat mass, fat-free mass, percentage body fat in total body and body segments are obtained. | Diagnostic test | Healthy children |
| Urine unclear magnetic resonance metabolomicsMetabolites in the urine are estimated by 600 MHz nuclear magnetic resonance. | Diagnostic test | Healthy children |
| Hand grip strengthHand grip strength in both hands is measured by hand-held dynamometer. | Diagnostic test | Healthy children |
Primary outcome
Correlation between bioelectrical impedance analysis parameters and the degree of fatty liver
Time frame: 24 months
Correlation body composition parameters by bioelectrical impedance analysis and controlled attenuation parameter by Fibroscan
1 secondary outcome
Correlation between urine metabolites and the degree of fatty liver
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- 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.
Li-Wen Lee, MD, PhD principal investigator
Chang Gung Memorial Hospital, Chiayi, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease and Body Composition, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 5 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 4 Aug 2021. 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 Taiwan. 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?
Contact Li-Wen Lee, MD, PhD (+886 5 3621 000 ext. 2382, m4572@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between bioelectrical impedance analysis parameters and the degree of fatty liver (time frame: 24 months). 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 4 Aug 2021; AzTrials last refreshed its copy on 1 Nov 2026.