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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
  Purpose

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.


Condition
Fatty Liver
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Influence of Apolipoprotein C3 Variants on Liver Steatosis and Serum Liver Enzyme Values in Obese Children

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

serum, WBC DNA


Estimated Enrollment: 200
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Obese children and adolescents in Taiwan

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682655

Contacts
Contact: Yu-Cheng Lin, MD, PhD 886-931122487 q92421006@ntu.edu.tw

Locations
Taiwan
Far Eastern Memorial Hospital Recruiting
New Taipei City, Taiwan, 220
Contact: Yu-Cheng Lin, MD, PhD    886-89667000 ext 4449    q92421006@ntu.edu.tw   
Principal Investigator: Yu-Cheng Lin, MD, PhD         
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Yu-Cheng Lin, MD, PhD Far Eastern Memorial Hospital
  More Information

No publications provided

Responsible Party: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01682655     History of Changes
Other Study ID Numbers: 101015-F
Study First Received: September 3, 2012
Last Updated: November 7, 2013
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Fatty Liver
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on November 27, 2014