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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Far Eastern Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01682655
First received: September 3, 2012
Last updated: November 7, 2013
Last verified: November 2013

September 3, 2012
November 7, 2013
July 2012
December 2014   (final data collection date for primary outcome measure)
genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without liver steatosis [ Time Frame: Oct 2013 ~ Dec 2014 (Anticipated) ] [ Designated as safety issue: No ]
genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without liver steatosis [ Time Frame: at the time of enrollment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01682655 on ClinicalTrials.gov Archive Site
genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without insulin resistance [ Time Frame: Oct 2013 ~ Dec 2014 (Anticipated) ] [ Designated as safety issue: No ]
genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without insulin resistance [ Time Frame: at the time of enrollment ] [ Designated as safety issue: No ]
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Genetic Variant in Apolipoprotein C3 Gene and Fatty Liver in Obese Children
The Influence of Apolipoprotein C3 Variants on Liver Steatosis and Serum Liver Enzyme Values in Obese Children

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

serum, WBC DNA

Non-Probability Sample

Obese children and adolescents in Taiwan

  • Fatty Liver
  • Obesity
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
6 Years to 18 Years
No
Contact: Yu-Cheng Lin, MD, PhD 886-931122487 q92421006@ntu.edu.tw
Taiwan
 
NCT01682655
101015-F
Yes
Far Eastern Memorial Hospital
Far Eastern Memorial Hospital
Not Provided
Principal Investigator: Yu-Cheng Lin, MD, PhD Far Eastern Memorial Hospital
Far Eastern Memorial Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP