Predicting Obesity Consequences Using Body Measure and Urine Metabolomics

NCT ID: NCT04989062

Last Updated: 2021-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2022-07-31

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.

Conditions

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Non-Alcoholic Fatty Liver Disease Body Composition Electric Impedance

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Fibroscan

Intervention Type DIAGNOSTIC_TEST

Controlled attenuation parameter and liver stiffness measurement are measured.

Bioelectrical impedance analysis

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Metabolites in the urine are estimated by 600 MHz nuclear magnetic resonance.

Hand grip strength

Intervention Type DIAGNOSTIC_TEST

Hand grip strength in both hands is measured by hand-held dynamometer.

Interventions

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Fibroscan

Controlled attenuation parameter and liver stiffness measurement are measured.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Urine unclear magnetic resonance metabolomics

Metabolites in the urine are estimated by 600 MHz nuclear magnetic resonance.

Intervention Type DIAGNOSTIC_TEST

Hand grip strength

Hand grip strength in both hands is measured by hand-held dynamometer.

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Li-Wen Lee

Consultant Radiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li-Wen Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital, Chiayi, Taiwan

Locations

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Chang Gung Memorial Hospital

Chiayi City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Li-Wen Lee, MD, PhD

Role: CONTACT

+886 5 3621 000 ext. 2382

Facility Contacts

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Li-Wen Lee, MD, PhD

Role: primary

+886 5 3621 000 ext. 2382

Other Identifiers

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201901889A3

Identifier Type: -

Identifier Source: org_study_id

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