<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/NCT04447391</url>
  </required_header>
  <id_info>
    <org_study_id>04-2015-015</org_study_id>
    <nct_id>NCT04447391</nct_id>
  </id_info>
  <brief_title>Effects of a 12-week Combined Exercise Program on Ghrelins in Obese Adolescent Girls</brief_title>
  <official_title>Effects of a 12-week Combined Exercise Program on Acylated and Desacyl Ghrelin, and Ghrelin O Acyl Transferase in Obese Adolescent Girls</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pusan National University Yangsan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pusan National University Yangsan Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to explore the effects of a 12-week combined exercise on ghrelin O acyl&#xD;
      transferase, acylated ghrelin and desacylated ghrelin levels in obese girls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Little is known about on ghrelin O acyl transferase (GOAT), acylated ghrelin (AG) and&#xD;
      desacylated ghrelin (DAG) levels during long-term exercise in adolescent population. Our&#xD;
      previous study showed that combined exercise program in overweight children increases DAG&#xD;
      with unchanged AG. This study aimed to explore the effects of a 12-week combined exercise on&#xD;
      GOAT, AG, and DAG in obese girls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 10, 2015</start_date>
  <completion_date type="Actual">December 31, 2015</completion_date>
  <primary_completion_date type="Actual">December 30, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>body fat percent</measure>
    <time_frame>Change from baseline body fat percent at 12 weeks</time_frame>
    <description>Changes in body fat percent during 12 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>acylated ghrelin</measure>
    <time_frame>Change from concentrations of baseline acylated ghrelin at 12 weeks</time_frame>
    <description>Changes in concentrations of acylated ghrelin during 12 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>desacylated ghrelin</measure>
    <time_frame>Change from concentrations of baseline desacylated ghrelin at 12 weeks</time_frame>
    <description>Changes in concentrations of desacylated ghrelin during 12 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ghrelin O acyl transferase</measure>
    <time_frame>Change from baseline concentrations of ghrelin O acyl transferase at 12 weeks</time_frame>
    <description>Changes in concentrations of ghrelin O acyl transferase during 12 weeks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Ghrelin</condition>
  <arm_group>
    <arm_group_label>Exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise group who performed a combined exercise and 300 kcal/day deficit diet during 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control group who performed 300 kcal/day deficit diet during 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Combined exercise program</intervention_name>
    <description>Combined exercise programme, consisting of warm-up, aerobic exercise, resistance training, and cool-down, 3 days a week after school for 50 minutes from 17;30 under supervision by a trainer plus 300 kcal deficit diet</description>
    <arm_group_label>Exercise group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>300 kcal deficit diet only</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  girls between 16 and 18 years&#xD;
&#xD;
          -  being classified as being overweight or obese defined with the 85th percentile of body&#xD;
             mass index or above based on the 2007 growth chart for Korean children aged 2-18&#xD;
             years.&#xD;
&#xD;
          -  After consultation with a physician, they were required to be considered physically&#xD;
             healthy enough to engage in regular exercise after school.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  participation in any weight-management programme in the past 6 months&#xD;
&#xD;
          -  engagement in other exercise programs except for regular physical education at school&#xD;
&#xD;
          -  smoking&#xD;
&#xD;
          -  amenorrhea for consecutive 2 months or more&#xD;
&#xD;
          -  being treated for hereditary diseases, mental disorder, hypertension, diabetes&#xD;
             mellitus, or musculoskeletal impairments&#xD;
&#xD;
          -  taking any medication or supplements for weight control&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sang Yeoup Lee, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pusan National University Yangsan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pusan National University Yangsan Hospital</name>
      <address>
        <city>Yangsan</city>
        <state>Gyeungsangnam-do</state>
        <zip>50612</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pusan National University Yangsan Hospital</investigator_affiliation>
    <investigator_full_name>Sang Yeoup Lee</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04447391
org study id: 04-2015-015
nct id: NCT04447391
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aimed to explore the effects of a 12-week combined exercise on ghrelin O acyl
      transferase, acylated ghrelin and desacylated ghrelin levels in obese girls.
Little is known about on ghrelin O acyl transferase (GOAT), acylated ghrelin (AG) and
      desacylated ghrelin (DAG) levels during long-term exercise in adolescent population. Our
      previous study showed that combined exercise program in overweight children increases DAG
      with unchanged AG. This study aimed to explore the effects of a 12-week combined exercise on
      GOAT, AG, and DAG in obese girls.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Care Provider, Outcomes Assessor)
measure: body fat percent
time frame: Change from baseline body fat percent at 12 weeks
description: Changes in body fat percent during 12 weeks
measure: acylated ghrelin
time frame: Change from concentrations of baseline acylated ghrelin at 12 weeks
description: Changes in concentrations of acylated ghrelin during 12 weeks
measure: desacylated ghrelin
time frame: Change from concentrations of baseline desacylated ghrelin at 12 weeks
description: Changes in concentrations of desacylated ghrelin during 12 weeks
measure: ghrelin O acyl transferase
time frame: Change from baseline concentrations of ghrelin O acyl transferase at 12 weeks
description: Changes in concentrations of ghrelin O acyl transferase during 12 weeks
arm group label: Exercise group
arm group type: Experimental
description: Exercise group who performed a combined exercise and 300 kcal/day deficit diet during 12 weeks.
arm group label: Control group
arm group type: Placebo Comparator
description: Control group who performed 300 kcal/day deficit diet during 12 weeks.
intervention type: Other
intervention name: Combined exercise program
description: Combined exercise programme, consisting of warm-up, aerobic exercise, resistance training, and cool-down, 3 days a week after school for 50 minutes from 17;30 under supervision by a trainer plus 300 kcal deficit diet
arm group label: Exercise group
intervention type: Other
intervention name: Control
description: 300 kcal deficit diet only
arm group label: Control group
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sang Yeoup Lee, MD, PhD
role: Principal Investigator
affiliation: Pusan National University Yangsan Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Pusan National University Yangsan Hospital
investigator full name: Sang Yeoup Lee
investigator title: Professor
sharing ipd: No