NCT04989062

Predicting Obesity Consequences Using Body Measure and Urine Metabolomics

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 13 Years
• Healthy volunteers: —

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Fibroscan	Controlled attenuation parameter and liver stiffness measurement are measured.
DIAGNOSTIC_TEST	Bioelectrical impedance analysis	Body composition measures including fat mass, fat-free mass, percentage body fat in total body and body segments are obtained.
DIAGNOSTIC_TEST	Urine unclear magnetic resonance metabolomics	Metabolites in the urine are estimated by 600 MHz nuclear magnetic resonance.
DIAGNOSTIC_TEST	Hand grip strength	Hand grip strength in both hands is measured by hand-held dynamometer.

Timeline

• Start date: 2020-08-01
• Primary completion: 2022-07-31
• Completion: 2022-07-31
• First posted: 2021-08-04
• Last updated: 2021-08-04

Locations

1 site across 1 country: Taiwan