<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/NCT01668888</url>
  </required_header>
  <id_info>
    <org_study_id>KoreaHealth_Progranulin</org_study_id>
    <nct_id>NCT01668888</nct_id>
  </id_info>
  <brief_title>Progranulin and CTRP3 in Metabolic Syndrome</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Korea University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Korea University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Inflammation has been known to be a pivotal pathogenic mechanism of obesity-related disorders&#xD;
      such as type 2 diabetes, metabolic syndrome and atherosclerosis. Adipose tissue functions as&#xD;
      a major endocrine organ by adipokine mediated modulation of a number of signaling cascades in&#xD;
      target tissues, that has pro-inflammatory or anti-inflammatory activities. Progranulin and&#xD;
      CTRP3 are recently discovered novel adipokines. Therefore, the investigators tried to clarify&#xD;
      the clinical meaning of these two adipokines in the subjects with or without metabolic&#xD;
      syndrome&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Serum concentration of progranulin in the subjects with metabolic syndrome</measure>
    <time_frame>12week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum concentration of CTRP3 in the subjects with metabolic syndrome</measure>
    <time_frame>12week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The relationship of serum progranulin levels with cardiovascular risk factors</measure>
    <time_frame>12 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The relationship of serum CTRP3 levels with cardiovascular risk factors</measure>
    <time_frame>12 week</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">127</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Apparently Helathy Subjects</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The subjects who visited for a routine health check-up at the Health Promotion Center of&#xD;
        Korea University Guro Hospital were enrolled using predefined inclusion and exclusion&#xD;
        criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20&lt;age&lt;80&#xD;
&#xD;
          -  apparently healthy subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a history of CVD&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  stage 2 hypertension&#xD;
&#xD;
          -  malignancy&#xD;
&#xD;
          -  severe renal or hepatic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Korea University Guro Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>August 16, 2012</last_update_submitted>
  <last_update_submitted_qc>August 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Korea University</investigator_affiliation>
    <investigator_full_name>K. M. Choi</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT01668888
org study id: KoreaHealth_Progranulin
nct id: NCT01668888
lead sponsor: 
has dmc: Yes
Inflammation has been known to be a pivotal pathogenic mechanism of obesity-related disorders
      such as type 2 diabetes, metabolic syndrome and atherosclerosis. Adipose tissue functions as
      a major endocrine organ by adipokine mediated modulation of a number of signaling cascades in
      target tissues, that has pro-inflammatory or anti-inflammatory activities. Progranulin and
      CTRP3 are recently discovered novel adipokines. Therefore, the investigators tried to clarify
      the clinical meaning of these two adipokines in the subjects with or without metabolic
      syndrome
observational model: Cohort
time perspective: Cross-Sectional
measure: Serum concentration of progranulin in the subjects with metabolic syndrome
time frame: 12week
measure: Serum concentration of CTRP3 in the subjects with metabolic syndrome
time frame: 12week
measure: The relationship of serum progranulin levels with cardiovascular risk factors
time frame: 12 week
measure: The relationship of serum CTRP3 levels with cardiovascular risk factors
time frame: 12 week
arm group label: Apparently Helathy Subjects
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Korea University
investigator full name: K. M. Choi
investigator title: Professor
mesh term: Metabolic Syndrome
mesh term: Syndrome