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Nonalcoholic Fatty Liver Disease in Taiwanese Children

Sponsor
Far Eastern Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00274183
Collaborator
(none)
614
Enrollment
1
Location
156
Actual Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Nonalcoholic fatty liver disease (NAFLD) is an emerging and important disease in Taiwan. However, the prevalence and clinical characteristics have not been studied well. The purpose of this study is to resolve the aforementioned problem.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    [Study Subjects] Obesity was defined as the BMI value > 95 percentile by different age- and gender groups according to the standards of the Department of Health in Taiwan.

    [Data Collection] The following data were obtained for each subject: age, gender, BMI, waist and hip circumference. BMI was calculated as body weight (kg)/ height (m2).

    In fasting venous blood samples, we measured total serum bilirubin, alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase, fasting glucose, triglyceride, total cholesterol,high-density lipoprotein cholesterol, insulin, glucose, and adiponectin.

    [Liver Ultrasonography] All participants underwent an ultrasonographic study of the liver performed by one operator.

    NAFLD was defined as the presence of an ultrasonographic pattern consistent with the following criteria: liver-kidney echo discrepancy, attenuated echo penetration and visibility of diaphragm, and obscure hepatic vessel structures.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    614 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prevalence, Clinicopathological Characteristics, Biomarkers and Genetics of Nonalcoholic Steatohepatitis in Taiwanese Children
    Actual Study Start Date :
    Jan 1, 2006
    Actual Primary Completion Date :
    Dec 1, 2018
    Actual Study Completion Date :
    Dec 31, 2018

    Outcome Measures

    Primary Outcome Measures

    1. non-alcoholic fatty liver disease [one year]

      confirmed by liver ultrasonography

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • diagnosis of fatty liver
    Exclusion Criteria:
    • other hepatic diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Far Eastern Memorial Hospital Taipei Taiwan 220

    Sponsors and Collaborators

    • Far Eastern Memorial Hospital

    Investigators

    • Principal Investigator: Yu-Cheng Lin, M.D., Far Eastern Memorial Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Far Eastern Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT00274183
    Other Study ID Numbers:
    • 94034
    First Posted:
    Jan 10, 2006
    Last Update Posted:
    Apr 9, 2019
    Last Verified:
    Dec 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Fatty Liver

    Study Results

    No Results Posted as of Apr 9, 2019