Nonalcoholic Fatty Liver Disease in Taiwanese Children

Fatty Liver Clinical Trial

Official title:

Prevalence, Clinicopathological Characteristics, Biomarkers and Genetics of Nonalcoholic Steatohepatitis in Taiwanese Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274183
• Other study ID #: 94034
• Status: Completed
• Start date: January 2006
• Est. completion date: December 31, 2018

Study information

• Verified date: December 2018
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 614
• Est. completion date: December 31, 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• diagnosis of fatty liver

Exclusion Criteria:

• other hepatic diseases

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	non-alcoholic fatty liver disease	confirmed by liver ultrasonography	one year