Nonalcoholic Fatty Liver Disease in Taiwanese Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00274183
Recruitment Status : Recruiting
First Posted : January 10, 2006
Last Update Posted : March 30, 2017
Information provided by (Responsible Party):
Far Eastern Memorial Hospital

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
Fatty Liver

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 Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence, Clinicopathological Characteristics, Biomarkers and Genetics of Nonalcoholic Steatohepatitis in Taiwanese Children
Study Start Date : January 2006
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2019

Primary Outcome Measures :
  1. non-alcoholic fatty liver disease confirmed by liver ultrasonography [ Time Frame: one year ]

Biospecimen Retention:   Samples With DNA
Serum, WBC DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Obese children will be enrolled from elementary school and high school in Taiwan

Inclusion Criteria:

  • diagnosis of fatty liver

Exclusion Criteria:

  • other hepatic diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00274183

Contact: Yu-Cheng Lin, M.D. 886-2-89667000 ext 4449

Far Eastern Memorial Hospital Recruiting
Taipei, Taiwan, 220
Contact: Yu-Cheng Lin, MD    0931122487   
Sponsors and Collaborators
Far Eastern Memorial Hospital
Principal Investigator: Yu-Cheng Lin, M.D. Far Eastern Memorial Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Far Eastern Memorial Hospital Identifier: NCT00274183     History of Changes
Other Study ID Numbers: 94034
First Posted: January 10, 2006    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases