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NCT04989062 Clinical Trial

Predicting Obesity Consequences Using Body Measure and Urine Metabolomics

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:
Predicting Obesity Consequences Using Body Measure and Urine Metabolomics

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04989062
Other study ID # 201901889A3
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date July 31, 2022

Study information
Verified date July 2021
Source Chang Gung Memorial Hospital
Contact Li-Wen Lee, MD, PhD
Phone +886 5 3621 000
Email m4572@cgmh.org.tw
Is FDA regulated No
Health authority
Study type Observational

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1200
Est. completion date July 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers
Gender All
Age group 6 Years to 13 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Taiwan Chang Gung Memorial Hospital Chiayi City

Sponsors (2)
Lead Sponsor Collaborator
Chang Gung Memorial Hospital Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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