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Clinical Trials/NCT04989062
NCT04989062
Unknown
Not Applicable

Predicting Obesity Consequences Using Body Measure and Urine Metabolomics

Chang Gung Memorial Hospital1 site in 1 country1,200 target enrollmentAugust 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Non-Alcoholic Fatty Liver Disease
Sponsor
Chang Gung Memorial Hospital
Enrollment
1200
Locations
1
Primary Endpoint
Correlation between bioelectrical impedance analysis parameters and the degree of fatty liver
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2020
End Date
July 31, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Principal Investigator
Principal Investigator

Li-Wen Lee

Consultant Radiologist

Chang Gung Memorial Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Correlation between bioelectrical impedance analysis parameters and the degree of fatty liver

Time Frame: 24 months

Correlation body composition parameters by bioelectrical impedance analysis and controlled attenuation parameter by Fibroscan

Secondary Outcomes

  • Correlation between urine metabolites and the degree of fatty liver(24 months)

Study Sites (1)

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