Predicting Obesity Consequences Using Body Measure and Urine Metabolomics

• Conditions: Non-Alcoholic Fatty Liver Disease; Electric Impedance; Body Composition
• Interventions: Diagnostic Test: Fibroscan; Diagnostic Test: Bioelectrical impedance analysis; Diagnostic Test: Urine unclear magnetic resonance metabolomics; Diagnostic Test: Hand grip strength

• Registration Number: NCT04989062
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2020-08-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-11
• Study First Submitted QC: 2021-07-24
• Last Update Submitted: 2021-07-24
• Study First Posted: 2021-08-04
• Last Update Posted: 2021-08-04
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy children	Urine unclear magnetic resonance metabolomics	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.
Healthy children	Hand grip strength	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.
Healthy children	Fibroscan	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.
Healthy children	Bioelectrical impedance analysis	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.

Primary Outcome Measures

Name	Time	Method
Correlation between bioelectrical impedance analysis parameters and the degree of fatty liver	24 months	Correlation body composition parameters by bioelectrical impedance analysis and controlled attenuation parameter by Fibroscan

Secondary Outcome Measures

Name	Time	Method
Correlation between urine metabolites and the degree of fatty liver	24 months	Correlation between urine metabolites by nuclear magnetic resonance and controlled attenuation value parameter by Fibroscan

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Chiayi City, Taiwan