<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/NCT01688622</url>
  </required_header>
  <id_info>
    <org_study_id>KoreaSO_Exercise</org_study_id>
    <nct_id>NCT01688622</nct_id>
  </id_info>
  <brief_title>Glypican4 and CTRP5 in Metabolic Syndrome and the Effect of Exercise on These Adipokines</brief_title>
  <official_title>Effects of Exercise on Glypican4,CTRP3,5 and RBP4 Levels and Circulating Levels of These Adipokines in the Subjects With or Without Metabolic Syndrome</official_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>
      Glypican4, CTRP3, CTRP5 are emerging novel adipokines mediating obesity and inflammation&#xD;
      related disorders. RBP4 and adiponectin are well known important adipokines. Therefore, we&#xD;
      examine the circulating levels of theses adipokines in the subjects with or without metabolic&#xD;
      syndrome. Furthermore, we tried to clarify the effect of exercise on the circulating these&#xD;
      adipokines.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The changes of circulating glypican4 levels after 3 months exercise</measure>
    <time_frame>baseline and 12weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The changes of circulating CTRP3 levels after 3 months exercise</measure>
    <time_frame>baseline and 12weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The changes of circulating CTRP5 levels after 3 months exercise</measure>
    <time_frame>baseline and 12weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The changes of circulating RBP4 levels after 3 months exercise</measure>
    <time_frame>baseline and 12weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The changes of circulating adiponectin levels after 3 months exercise</measure>
    <time_frame>baseline and 12weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Circulating glypican4 levels in the subjects with or without metabolic syndrome</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating CTRP3 levels in the subjects with or without metabolic syndrome</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating CTRP5 levels in the subjects with or without metabolic syndrome</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating RBP4 levels in the subjects with or without metabolic syndrome</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating adiponectin levels in the subjects with or without metabolic syndrome</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Metabolic Syndrome</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>obese women who are volunteers for the 3 months exercise programs</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>3months Exercise</intervention_name>
    <description>training session consisting of a brief warm-up, followed by an approximately 45-min session of aerobic exercise at an intensity of 60-75% of the age-predicted maximum heart rate (approximately 300 kcal/day) and a 20-min muscle strength train- ing programme (approximately 100 kcal/day), followed by a brief cool-down period.</description>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women between 30 and 60 years of age who had a body mass index (BMI) more than 25&#xD;
             kg/m2&#xD;
&#xD;
          -  The subjects of metabolic syndrome and age, gender matched non metabolic syndrome&#xD;
             among the participants of Korean SO Study (KSOS) study, which is an ongoing&#xD;
             epidemiologic study supported by the Korea Science and Engineering Foundation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  participants had a history of cardiovascular disease&#xD;
&#xD;
          -  any type of diabetes&#xD;
&#xD;
          -  stage 2 hypertension&#xD;
&#xD;
          -  malignant disease, severe renal, or hepatic disease&#xD;
&#xD;
          -  Subjects taking medications that might affect body weight or body composition&#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>September 2012</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>September 20, 2012</last_update_submitted>
  <last_update_submitted_qc>September 20, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 21, 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/NCT01688622
org study id: KoreaSO_Exercise
nct id: NCT01688622
lead sponsor: 
has dmc: Yes
Glypican4, CTRP3, CTRP5 are emerging novel adipokines mediating obesity and inflammation
      related disorders. RBP4 and adiponectin are well known important adipokines. Therefore, we
      examine the circulating levels of theses adipokines in the subjects with or without metabolic
      syndrome. Furthermore, we tried to clarify the effect of exercise on the circulating these
      adipokines.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: The changes of circulating glypican4 levels after 3 months exercise
time frame: baseline and 12weeks
measure: The changes of circulating CTRP3 levels after 3 months exercise
time frame: baseline and 12weeks
measure: The changes of circulating CTRP5 levels after 3 months exercise
time frame: baseline and 12weeks
measure: The changes of circulating RBP4 levels after 3 months exercise
time frame: baseline and 12weeks
measure: The changes of circulating adiponectin levels after 3 months exercise
time frame: baseline and 12weeks
measure: Circulating glypican4 levels in the subjects with or without metabolic syndrome
time frame: baseline
measure: Circulating CTRP3 levels in the subjects with or without metabolic syndrome
time frame: baseline
measure: Circulating CTRP5 levels in the subjects with or without metabolic syndrome
time frame: baseline
measure: Circulating RBP4 levels in the subjects with or without metabolic syndrome
time frame: baseline
measure: Circulating adiponectin levels in the subjects with or without metabolic syndrome
time frame: baseline
arm group label: Exercise
arm group type: Other
description: obese women who are volunteers for the 3 months exercise programs
intervention type: Behavioral
intervention name: 3months Exercise
description: training session consisting of a brief warm-up, followed by an approximately 45-min session of aerobic exercise at an intensity of 60-75% of the age-predicted maximum heart rate (approximately 300 kcal/day) and a 20-min muscle strength train- ing programme (approximately 100 kcal/day), followed by a brief cool-down period.
arm group label: Exercise
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