Nonalcoholic Fatty Liver Disease in Taiwanese Children

This study is currently recruiting participants.
Verified November 2013 by Far Eastern Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00274183
First received: January 2, 2006
Last updated: November 7, 2013
Last verified: November 2013

January 2, 2006
November 7, 2013
January 2006
December 2014   (final data collection date for primary outcome measure)
non-alcoholic fatty liver disease confirmed by liver ultrasonography [ Time Frame: one year ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00274183 on ClinicalTrials.gov Archive Site
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Nonalcoholic Fatty Liver Disease in Taiwanese Children
Prevalence, Clinicopathological Characteristics, Biomarkers and Genetics of Nonalcoholic Steatohepatitis in Taiwanese Children

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.

[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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Serum, WBC DNA

Probability Sample

Obese children will be enrolled from elementary school and high school in Taiwan

Fatty Liver
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Lin YC, Chang PF, Chang MH, Ni YH. A common variant in the peroxisome proliferator-activated receptor-γ coactivator-1α gene is associated with nonalcoholic fatty liver disease in obese children. Am J Clin Nutr. 2013 Feb;97(2):326-31. doi: 10.3945/ajcn.112.046417. Epub 2012 Dec 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosis of fatty liver

Exclusion Criteria:

  • other hepatic diseases
Both
6 Years to 18 Years
No
Contact: Yu-Cheng Lin, M.D. 886-2-89667000 ext 4449 q92421006@ntu.edu.tw
Taiwan
 
NCT00274183
94034
Yes
Far Eastern Memorial Hospital
Far Eastern Memorial Hospital
Not Provided
Principal Investigator: Yu-Cheng Lin, M.D. Far Eastern Memorial Hospital
Far Eastern Memorial Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP