Predicting Obesity Consequences Using Body Measure and Urine Metabolomics

NCT04989062 | Unknown

• 1 other identifier: 201901889A3
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Alcoholic Fatty Liver Disease; Body Composition; Electric Impedance

Keywords

Non-Alcoholic Fatty Liver Disease; Body Composition; Electric Impedance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation between urine metabolites and the degree of fatty liver

  24 months

Study Arms (1)

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; Diagnostic Test: Bioelectrical impedance analysis; Diagnostic Test: Urine unclear magnetic resonance metabolomics; Diagnostic Test: Hand grip strength

Interventions

Fibroscan DIAGNOSTIC_TEST

Controlled attenuation parameter and liver stiffness measurement are measured.

Healthy children

Bioelectrical impedance analysis DIAGNOSTIC_TEST

Body composition measures including fat mass, fat-free mass, percentage body fat in total body and body segments are obtained.

Healthy children

Urine unclear magnetic resonance metabolomics DIAGNOSTIC_TEST

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

Healthy children

Hand grip strength DIAGNOSTIC_TEST

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

Healthy children

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Apparently healthy male or female children
• Students in Year 1 to Year 6 of primary schools

You may not qualify if:

• Unknown liver disease
• Metal implant or splint
• Pacemaker implantation
• Limb defect or injury
• Pregnancy

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Chiayi City, 61363, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Hand Strength

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Muscle Strength; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Li-Wen Lee, MD, PhD

  Chang Gung Memorial Hospital, Chiayi, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li-Wen Lee, MD, PhD

CONTACT

+886 5 3621 000; m4572@cgmh.org.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Radiologist

Study Record Dates

• First Submitted: July 11, 2021
• First Posted: August 4, 2021
• Study Start: August 1, 2020
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)