Predicting Obesity Consequences Using Body Measure and Urine Metabolomics

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.

Study Overview

• Status: Recruiting
• Conditions: Body Composition; Electric Impedance; Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Diagnostic test: Fibroscan; Diagnostic test: Bioelectrical impedance analysis; Diagnostic test: Urine unclear magnetic resonance metabolomics; Diagnostic test: Hand grip strength

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 Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

• Study Contact: Name: Li-Wen Lee, MD, PhD; Phone Number: 2382 +886 5 3621 000; Email: m4572@cgmh.org.tw

Study Locations

• Taiwan
  • Chiayi City, Taiwan, 61363
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Li-Wen Lee, MD, PhD; Phone Number: 2382 +886 5 3621 000; Email: m4572@cgmh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 13 years (CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants in the Year 1 to Year 6 of primary school (aged 6-13 years) without liver disease will be recruited for body measure, urine sampling and Fibroscan test.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: Ministry of Science and Technology, Taiwan
• Investigators: Principal Investigator: Li-Wen Lee, MD, PhD, Chang Gung Memorial Hospital, Chiayi, Taiwan

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2020
• Primary Completion (ANTICIPATED): July 31, 2022
• Study Completion (ANTICIPATED): July 31, 2022

Study Registration Dates

• First Submitted: July 11, 2021
• First Submitted That Met QC Criteria: July 24, 2021
• First Posted (ACTUAL): August 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2021
• Last Update Submitted That Met QC Criteria: July 24, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Body Composition; Non-Alcoholic Fatty Liver Disease; Electric Impedance
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 201901889A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No