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

Obesity Clinical Trial

Official title:

The Influence of Apolipoprotein C3 Variants on Liver Steatosis and Serum Liver Enzyme Values in Obese Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682655
• Other study ID #: 101015-F
• Status: Completed
• Phase: N/A
• First received: September 3, 2012
• Last updated: March 10, 2015
• Start date: July 2012
• Est. completion date: December 2014

Study information

• Verified date: November 2013
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fatty Liver
• Obesity

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	New Taipei City

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	genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without liver steatosis		Oct 2013 ~ Dec 2014	No
Secondary	genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without insulin resistance		Oct 2013 ~ Dec 2014	No