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Predicting Obesity Consequences Using Body Measure and Urine Metabolomics

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Unknown

Conditions

Electric Impedance
Body Composition
Non-Alcoholic Fatty Liver Disease

Treatments

Diagnostic Test: Hand grip strength
Diagnostic Test: Fibroscan
Diagnostic Test: Bioelectrical impedance analysis
Diagnostic Test: Urine unclear magnetic resonance metabolomics

Study type

Observational

Funder types

Other

Identifiers

NCT04989062
201901889A3

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,200 estimated patients

Sex

All

Ages

6 to 13 years old

Volunteers

No Healthy Volunteers

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

Trial design

1,200 participants in 1 patient group

Healthy children
Description:
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.
Treatment:
Diagnostic Test: Fibroscan
Diagnostic Test: Hand grip strength
Diagnostic Test: Urine unclear magnetic resonance metabolomics
Diagnostic Test: Bioelectrical impedance analysis

Trial contacts and locations

1

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Central trial contact

Li-Wen Lee, MD, PhD

Data sourced from clinicaltrials.gov

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