Nonalcoholic Fatty Liver Disease in Taiwanese Children
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Purpose
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.
| Condition |
|---|
|
Fatty Liver |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prevalence, Clinicopathological Characteristics, Biomarkers and Genetics of Nonalcoholic Steatohepatitis in Taiwanese Children |
DNA samples will be studied for the candidate genes of fatty liver disease.
| Estimated Enrollment: | 250 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | December 2015 |
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.
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Obese children will be enrolled from elementary school and high school in Taiwan
Inclusion Criteria:
- diagnosis of fatty liver
Exclusion Criteria:
- other hepatic diseases
Contacts and Locations| Contact: Yu-Cheng Lin, M.D. | 886-2-89667000 ext 4449 | q92421006@ntu.edu.tw |
| Taiwan | |
| Far Eastern Memorial Hospital | Recruiting |
| Taipei, Taiwan, 220 | |
| Contact: Yu-Cheng Lin, MD 0931122487 q92421006@ntu.edu.tw | |
| Principal Investigator: | Yu-Cheng Lin, M.D. | Far Eastern Memorial Hospital |
More Information
No publications provided by Far Eastern Memorial Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Far Eastern Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00274183 History of Changes |
| Other Study ID Numbers: | 94034 |
| Study First Received: | January 2, 2006 |
| Last Updated: | August 30, 2012 |
| Health Authority: | Taiwan: Department of Health |
Additional relevant MeSH terms:
|
Fatty Liver Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013