Predicting Obesity Consequences Using Body Measure and Urine Metabolomics

Study Overview
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Brief Summary
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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
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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.

Official Title
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Predicting Obesity Consequences Using Body Measure and Urine Metabolomics

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

Intervention / Treatment
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* Diagnostic Test: Fibroscan
* Diagnostic Test: Bioelectrical impedance analysis
* Diagnostic Test: Urine unclear magnetic resonance metabolomics
* Diagnostic Test: Hand grip strength


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy children<br>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. | Diagnostic Test: Fibroscan<br>* Controlled attenuation parameter and liver stiffness measurement are measured.<br>Diagnostic Test: Bioelectrical impedance analysis<br>* Body composition measures including fat mass, fat-free mass, percentage body fat in total body and body segments are obtained.<br>Diagnostic Test: Urine unclear magnetic resonance metabolomics<br>* Metabolites in the urine are estimated by 600 MHz nuclear magnetic resonance.<br>Diagnostic Test: Hand grip strength<br>* Hand grip strength in both hands is measured by hand-held dynamometer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Alcoholic Fatty Liver Disease, Body Composition, Electric Impedance