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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01682655
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Far Eastern Memorial Hospital

Tracking Information
First Submitted Date September 3, 2012
First Posted Date September 11, 2012
Last Update Posted Date March 17, 2015
Study Start Date July 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 10, 2015)
genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without liver steatosis [ Time Frame: Oct 2013 ~ Dec 2014 ]
Original Primary Outcome Measures
 (submitted: September 6, 2012)
genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without liver steatosis [ Time Frame: at the time of enrollment ]
Change History
Current Secondary Outcome Measures
 (submitted: March 10, 2015)
genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without insulin resistance [ Time Frame: Oct 2013 ~ Dec 2014 ]
Original Secondary Outcome Measures
 (submitted: September 6, 2012)
genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without insulin resistance [ Time Frame: at the time of enrollment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genetic Variant in Apolipoprotein C3 Gene and Fatty Liver in Obese Children
Official Title The Influence of Apolipoprotein C3 Variants on Liver Steatosis and Serum Liver Enzyme Values in Obese Children
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
serum, WBC DNA
Sampling Method Non-Probability Sample
Study Population Obese children and adolescents in Taiwan
Condition
  • Fatty Liver
  • Obesity
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 10, 2015)
500
Original Estimated Enrollment
 (submitted: September 6, 2012)
200
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01682655
Other Study ID Numbers 101015-F
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Far Eastern Memorial Hospital
Study Sponsor Far Eastern Memorial Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Yu-Cheng Lin, MD, PhD Far Eastern Memorial Hospital
PRS Account Far Eastern Memorial Hospital
Verification Date November 2013