Nonalcoholic Fatty Liver Disease in Taiwanese Children

This study is currently recruiting participants.
Verified June 2011 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: August 30, 2012
Last verified: June 2011

January 2, 2006
August 30, 2012
January 2006
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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 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. All participants' parents gave their informed consent, and the study was approved by the ethics committee of the Far Eastern Memorial Hospital.

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). The ratio between waist and hip circumference was calculated and referred to as the waist-to-hip ratio (WHR).

In fasting venous blood samples, we measured total serum bilirubin, alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase, fasting glucose, triglyceride, total cholesterol and high-density lipoprotein cholesterol. Insulin levels were measured using chemiluminescence immunoassay (DPC, Los Angeles, CA, USA). CRP levels were measured with the use of an immunonephelometry assay (Dade Behring Inc, Newark, USA). Serum adiponectin was determined by an ELISA kit (B-bridge, Tokyo, Japan). Insulin resistance was measured by the homeostasis model assessment of insulin resistance (HOMA-IR) and was calculated as follows: HOMA-IR = (fasting insulin [μU/mL])(fasting glucose [mmol/L]/22.5).

Liver Ultrasonography All participants underwent an ultrasonographic study of the liver performed by one operator. The hand-carried machine used (TITAN®, SonoSite Ltd, United Kingdom) was equipped with a 2-5 MHz convex probe.

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. The above-mentioned ultrasonographic pattern was scored as described by Chan et al. A score > 4 was used as the diagnostic criterion for pediatric NAFLD in this study.

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

DNA samples will be studied for the candidate genes of fatty liver disease.

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
250
December 2015
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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
June 2011

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