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Predicting Obesity Consequences Using Body Measure and Urine Metabolomics

Predicting Obesity Consequences Using Body Measure and Urine Metabolomics

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04989062
Enrollment
1200
Registered
2021-08-04
Start date
2020-08-01
Completion date
2022-07-31
Last updated
2021-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Alcoholic Fatty Liver Disease, Body Composition, Electric Impedance

Keywords

Non-Alcoholic Fatty Liver Disease, Body Composition, Electric Impedance

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTFibroscan

Controlled attenuation parameter and liver stiffness measurement are measured.

Body composition measures including fat mass, fat-free mass, percentage body fat in total body and body segments are obtained.

DIAGNOSTIC_TESTUrine unclear magnetic resonance metabolomics

Metabolites in the urine are estimated by 600 MHz nuclear magnetic resonance.

DIAGNOSTIC_TESTHand grip strength

Hand grip strength in both hands is measured by hand-held dynamometer.

Sponsors

Ministry of Science and Technology, Taiwan
CollaboratorOTHER_GOV
Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 13 Years

Inclusion criteria

* Apparently healthy male or female children * Students in Year 1 to Year 6 of primary schools

Exclusion criteria

* Unknown liver disease * Metal implant or splint * Pacemaker implantation * Limb defect or injury * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Correlation between bioelectrical impedance analysis parameters and the degree of fatty liver24 monthsCorrelation body composition parameters by bioelectrical impedance analysis and controlled attenuation parameter by Fibroscan

Secondary

MeasureTime frameDescription
Correlation between urine metabolites and the degree of fatty liver24 monthsCorrelation between urine metabolites by nuclear magnetic resonance and controlled attenuation value parameter by Fibroscan

Countries

Taiwan

Contacts

Primary ContactLi-Wen Lee, MD, PhD
m4572@cgmh.org.tw+886 5 3621 000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026