<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01682655</url>
  </required_header>
  <id_info>
    <org_study_id>101015-F</org_study_id>
    <nct_id>NCT01682655</nct_id>
  </id_info>
  <brief_title>Genetic Variant in Apolipoprotein C3 Gene and Fatty Liver in Obese Children</brief_title>
  <official_title>The Influence of Apolipoprotein C3 Variants on Liver Steatosis and Serum Liver Enzyme Values in Obese Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Far Eastern Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Far Eastern Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the past decades, obesity in children is much more prevalent in the world. Given the&#xD;
      increasing prevalence of pediatric obesity worldwide, fatty liver incidence is on the rise.&#xD;
&#xD;
      Genetic variant in apolipoprotein C3 (APOC3) gene is associated with increased liver fat&#xD;
      content in adults.&#xD;
&#xD;
      The aim of this study is to find out whether APOC3 single nucleotide polymorphism (SNP)&#xD;
      influence fatty liver in obese children and adolescent.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of this study is to assess the associations between to investigate the&#xD;
      association of rs2854117 C &gt; T and rs2854116 T &gt; C SNPs of the APOC3 gene with liver&#xD;
      steatosis, as measured by liver ultrasound.&#xD;
&#xD;
      As a secondary aim, the investigators will examine the associations between APOC3 rs2854117 C&#xD;
      &gt; T and rs2854116 T &gt; C SNPs and serum alanine aminotransferase (ALT) and aspartate&#xD;
      aminotransferase (AST) levels. In addition, the investigators will further analyze the&#xD;
      association with other biomarkers, such as body mass index, adiponectin and insulin&#xD;
      resistance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without liver steatosis</measure>
    <time_frame>Oct 2013 ~ Dec 2014</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without insulin resistance</measure>
    <time_frame>Oct 2013 ~ Dec 2014</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">500</enrollment>
  <condition>Fatty Liver</condition>
  <condition>Obesity</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum, WBC DNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Obese children and adolescents in Taiwan&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 6-18 years old&#xD;
&#xD;
          -  Obesity definition: BMI &gt; 95% according to the age- and gender-specific standard&#xD;
             suggested by National Health Institute in Taiwan&#xD;
&#xD;
          -  Willing to give written informed consent by parents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alcohol consumption&#xD;
&#xD;
          -  Chronic liver diseases, including hepatitis B, hepatitis C, Wilson disease and&#xD;
             autoimmune hepatitis&#xD;
&#xD;
          -  Major systemic diseases, including cardiopulmonary disease, renal failure, cancer, and&#xD;
             psychotic disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu-Cheng Lin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Far Eastern Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Far Eastern Memorial Hospital</name>
      <address>
        <city>New Taipei City</city>
        <zip>220</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>March 10, 2015</last_update_submitted>
  <last_update_submitted_qc>March 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatty Liver</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01682655
org study id: 101015-F
nct id: NCT01682655
lead sponsor: 
has dmc: Yes
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.
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.
observational model: Cohort
time perspective: Prospective
measure: genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without liver steatosis
time frame: Oct 2013 ~ Dec 2014
measure: genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without insulin resistance
time frame: Oct 2013 ~ Dec 2014
serum, WBC DNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
last name: Yu-Cheng Lin, MD, PhD
role: Principal Investigator
affiliation: Far Eastern Memorial Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Fatty Liver