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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04989062
Study type Observational
Source Chang Gung Memorial Hospital
Contact Li-Wen Lee, MD, PhD
Phone +886 5 3621 000
Email m4572@cgmh.org.tw
Status Recruiting
Phase
Start date August 1, 2020
Completion date July 31, 2022

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