Genetic Variant in Apolipoprotein C3 Gene and Fatty Liver in Obese Children

Completed

• Conditions: Fatty Liver; Obesity

• Registration Number: NCT01682655
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

In the past decades, obesity in children is much more prevalent in the world. Given the increasing prevalence of pediatric obesity worldwide, fatty liver incidence is on the rise.

Genetic variant in apolipoprotein C3 (APOC3) gene is associated with increased liver fat content in adults.

The aim of this study is to find out whether APOC3 single nucleotide polymorphism (SNP) influence fatty liver in obese children and adolescent.

Detailed Description

The primary aim of this study is to assess the associations between to investigate the association of rs2854117 C \> T and rs2854116 T \> C SNPs of the APOC3 gene with liver steatosis, as measured by liver ultrasound.

As a secondary aim, the investigators will examine the associations between APOC3 rs2854117 C \> T and rs2854116 T \> C SNPs and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels. In addition, the investigators will further analyze the association with other biomarkers, such as body mass index, adiponectin and insulin resistance.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-09-03
• Study First Submitted QC: 2012-09-06
• Study First Posted: 2012-09-11
• Status Verified: 2013-11
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Age 6-18 years old
• Obesity definition: BMI > 95% according to the age- and gender-specific standard suggested by National Health Institute in Taiwan
• Willing to give written informed consent by parents

Exclusion Criteria

• Alcohol consumption
• Chronic liver diseases, including hepatitis B, hepatitis C, Wilson disease and autoimmune hepatitis
• Major systemic diseases, including cardiopulmonary disease, renal failure, cancer, and psychotic disorder

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without liver steatosis	Oct 2013 ~ Dec 2014

Secondary Outcome Measures

Name	Time	Method
genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without insulin resistance	Oct 2013 ~ Dec 2014

Trial Locations

Locations (1)

Far Eastern Memorial Hospital; 🇨🇳 New Taipei City, Taiwan