Genetic Variant in Apolipoprotein C3 Gene and Fatty Liver in Obese Children
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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 genetic variant 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 |
- genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without liver steatosis [ Time Frame: Oct 2013 ~ Dec 2013 (Anticipated) ] [ Designated as safety issue: No ]
- genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without insulin resistance [ Time Frame: Oct 2013 ~ Dec 2013 (Anticipated) ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
serum, whit blood cell
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
In the past decades, obesity in children is much more prevalent in the world. Given the increasing prevalence of pediatric obesity worldwide, non-alcoholic fatty liver disease (NAFLD) incidence is on the rise.
The pathogenesis of NAFLD is multifactorial. NAFLD is strongly associated with obesity and insulin resistance. In addition to environmental risk factors, several studies have suggested that the individual genetic variations contributed to the NAFLD susceptibility or progression. In 2010, Shulman et al. demonstrated rs2854117 C > T and rs2854116 T > C single nucleotide polymorphisms (SNPs) in apolipoprotein C3 (APOC3) gene had a strong association with increased liver fat content.
APOC3 rs2854117 C > T and rs2854116 T > C SNPs had previously been found to be associated with increased plasma triglyceride levels. These two APOC3 variants lead to increased uptake of chylomicron remnants by the liver, which results in NAFLD and hepatic insulin resistance.
The study subjects of this report were Asian Indian adults. There was no data in terms of this genetic polymorphism in Chinese population and in children. Herein the investigators will test the hypothesis that APOC3 rs2854117 C > T and rs2854116 T > C SNPs are associated with liver steatosis and serum liver enzyme values in obese Taiwanese children.
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 ALT and 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 |
Obese children and adolescents in Taiwan
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, post-transplantation and psychotic disorder
Contacts and Locations| Contact: Yu-Cheng Lin, MD, PhD | 886-931122487 | q92421006@ntu.edu.tw |
| 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 | |
| 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: | September 11, 2012 |
| Health Authority: | Taiwan: Department of Health |
Additional relevant MeSH terms:
|
Fatty Liver Obesity Liver Diseases Digestive System Diseases Overnutrition |
Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013