NCT01682655

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 17, 2015

Status Verified

November 1, 2013

Enrollment Period

2.4 years

First QC Date

September 3, 2012

Last Update Submit

March 10, 2015

Conditions

Fatty LiverObesity

Outcome Measures

Primary Outcomes (1)

  • genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without liver steatosis

    Oct 2013 ~ Dec 2014

Secondary Outcomes (1)

  • genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without insulin resistance

    Oct 2013 ~ Dec 2014

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Obese children and adolescents in Taiwan

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, Taiwan, 220, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, WBC DNA

MeSH Terms

Conditions

Fatty LiverObesity

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yu-Cheng Lin, MD, PhD

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2012

First Posted

September 11, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 17, 2015

Record last verified: 2013-11

Locations

TW(1)