Clinical trial NCT04989062: Predicting Obesity Consequences Using Body Measure and Urine Metabolomics
Official title: Predicting Obesity Consequences Using Body Measure and Urine Metabolomics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-Alcoholic Fatty Liver Disease
Body Composition
Electric Impedance
Keywords: Non-Alcoholic Fatty Liver Disease
Body Composition
Electric Impedance
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2021-08-04
Enrollment: 1200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Correlation between bioelectrical impedance analysis parameters and the degree of fatty liver
timeFrame: 24 months
Secondary outcomes:
measure: Correlation between urine metabolites and the degree of fatty liver
timeFrame: 24 months
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital, Chiayi, Taiwan
name: Li-Wen Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: