Nonalcoholic Fatty Liver Disease in Taiwanese Children
|First Received Date ICMJE||January 2, 2006|
|Last Updated Date||August 30, 2012|
|Start Date ICMJE||January 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00274183 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Nonalcoholic Fatty Liver Disease in Taiwanese Children|
|Official Title ICMJE||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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Biospecimen||Retention: Samples With DNA
DNA samples will be studied for the candidate genes of fatty liver disease.
|Sampling Method||Probability Sample|
Obese children will be enrolled from elementary school and high school in Taiwan
|Condition ICMJE||Fatty Liver|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||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.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||250|
|Estimated Completion Date||December 2015|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||6 Years to 18 Years|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Taiwan|
|NCT Number ICMJE||NCT00274183|
|Other Study ID Numbers ICMJE||94034|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Far Eastern Memorial Hospital|
|Study Sponsor ICMJE||Far Eastern Memorial Hospital|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Far Eastern Memorial Hospital|
|Verification Date||June 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP