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

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ClinicalTrials.gov Identifier: NCT01682655
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Fatty Liver Obesity

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 Design

Study Type : Observational
Actual Enrollment : 500 participants
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
Study Start Date : July 2012
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without liver steatosis [ Time Frame: Oct 2013 ~ Dec 2014 ]

Secondary Outcome Measures :
  1. genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without insulin resistance [ Time Frame: Oct 2013 ~ Dec 2014 ]

Biospecimen Retention:   Samples With DNA
serum, WBC DNA

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682655


Locations
Taiwan
Far Eastern Memorial Hospital
New Taipei City, Taiwan, 220
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Yu-Cheng Lin, MD, PhD Far Eastern Memorial Hospital
More Information

Responsible Party: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01682655     History of Changes
Other Study ID Numbers: 101015-F
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: November 2013

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