<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/NCT04496388</url>
  </required_header>
  <id_info>
    <org_study_id>109-035</org_study_id>
    <nct_id>NCT04496388</nct_id>
  </id_info>
  <brief_title>The Effect of Different Types of Exercise on Insulin Resistance and Visceral Adipose Tissue in Community Residents.</brief_title>
  <official_title>The Effect of Different Types of Exercise on Insulin Resistance and Visceral Adipose Tissue in Community Residents.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Taiwan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Exercise has been proven to effectively reduce incidence of diabetes mellitus and&#xD;
      metabolic syndrome. However, there is controversial data from prior studies to inform the&#xD;
      type of exercise training recommendations.&#xD;
&#xD;
      Aim: The aim of this study will determine the differences of different type of exercise in&#xD;
      the effects of reducing insulin resistance and visceral adipose tissue for community&#xD;
      residents.&#xD;
&#xD;
      Methods: The four-arm randomized controlled trial will conducted in adults aged 40 to 70&#xD;
      years old in Tainan. A total of at least 177 patients will randomly assign to the group of&#xD;
      aerobic exercise (AE), aerobic exercise combined with resistance exercise (RE), AE combined&#xD;
      with medium intensity interval training, and placebo. The participants in exercise group will&#xD;
      received 12 weeks, 3 times per week program, including twice a week intervention guided by&#xD;
      the intervenors, and once a week exercise guided by the video at home. All the exercise keeps&#xD;
      moderate-intensity by monitoring with 64%-75% of the maximum heart rate. Insulin resistance&#xD;
      status will be checked by HOMA index at baseline and at exercise intervention after 12 weeks&#xD;
      (HOMA index= insulin μU/mL）× glucose（mmol/L）/22.5).&#xD;
&#xD;
      Relevance to clinical practice: The research findings will help the clinical health works to&#xD;
      know which type of exercise is the best choice in reducing insulin resistance and visceral&#xD;
      adipose tissue in community residents, and can be promoted to the general public to reduce&#xD;
      the prevalence of metabolic syndrome as well as prevent the root causes of ill health.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 7, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 2020</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>visceral adipose tissue</measure>
    <time_frame>time before intervention(T0) and after 12-weeks exercise intervention (T1)</time_frame>
    <description>measured by the body composition analyzer, which uses bioelectrical impedance analysis to estimate body composition.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>insulin resistance</measure>
    <time_frame>time before intervention(T0) and after 12-weeks exercise intervention (T1)</time_frame>
    <description>Blood samples.Insulin resistance status will be checked by HOMA index at baseline and at exercise intervention after 12 weeks (HOMA index= insulin （μU/mL）× glucose（mmol/L）/22.5). The insulin level and fasting sugar from blood sample will be checked to calculate the insulin resistance.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Exercise, Insulin Resistance, Visceral Adipose Tissue</condition>
  <arm_group>
    <arm_group_label>Aerobic exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aerobic exercise is lasting for nearly 50 minutes each time, including warm-up and stretching for 10 minutes after exercise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aerobic exercise combined with resistance exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aerobic exercise is lasting for nearly 20 minutes each time, and add resistance exercise for 20 minutes. Additional warm-up 10 minutes and stretching for 5 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aerobic exercise combined with interval training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aerobic exercise is lasting for nearly 20 minutes each time, and add moderal intensity interval training for 10 minutes. Additional warm-up 10 minutes and stretching for 15 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>No exercise intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>exercise</intervention_name>
    <description>different type of exercise</description>
    <arm_group_label>Aerobic exercise</arm_group_label>
    <arm_group_label>Aerobic exercise combined with interval training</arm_group_label>
    <arm_group_label>Aerobic exercise combined with resistance exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>No exercise intervention</intervention_name>
    <description>No exercise intervention</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults aged 40 to 70 years old.&#xD;
&#xD;
          -  without regular exercise in the past six years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  recent unstable condition involving stroke or those with heart disease, handicap,&#xD;
             pregnancy, mental disorders, systolic BP &gt; 200 mmHg, or diastolic BP &gt;110 mmHg.&#xD;
&#xD;
          -  those with contraindications in body composition analyzer measurement including people&#xD;
             with pacemakers, artificial metal joints, amputated hands or feet, and those who&#xD;
             cannot be cooperated with standing during testing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yu-Hsuan Chang</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>March 2, 2021</last_update_submitted>
  <last_update_submitted_qc>March 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Taiwan University</investigator_affiliation>
    <investigator_full_name>Yu-Hsuan Chang</investigator_full_name>
    <investigator_title>Principal Investigator, Nurse, ph D student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</mesh_term>
  </condition_browse>
  <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/NCT04496388
org study id: 109-035
nct id: NCT04496388
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background: Exercise has been proven to effectively reduce incidence of diabetes mellitus and
      metabolic syndrome. However, there is controversial data from prior studies to inform the
      type of exercise training recommendations.

      Aim: The aim of this study will determine the differences of different type of exercise in
      the effects of reducing insulin resistance and visceral adipose tissue for community
      residents.

      Methods: The four-arm randomized controlled trial will conducted in adults aged 40 to 70
      years old in Tainan. A total of at least 177 patients will randomly assign to the group of
      aerobic exercise (AE), aerobic exercise combined with resistance exercise (RE), AE combined
      with medium intensity interval training, and placebo. The participants in exercise group will
      received 12 weeks, 3 times per week program, including twice a week intervention guided by
      the intervenors, and once a week exercise guided by the video at home. All the exercise keeps
      moderate-intensity by monitoring with 64%-75% of the maximum heart rate. Insulin resistance
      status will be checked by HOMA index at baseline and at exercise intervention after 12 weeks
      (HOMA index= insulin μU/mL）× glucose（mmol/L）/22.5).

      Relevance to clinical practice: The research findings will help the clinical health works to
      know which type of exercise is the best choice in reducing insulin resistance and visceral
      adipose tissue in community residents, and can be promoted to the general public to reduce
      the prevalence of metabolic syndrome as well as prevent the root causes of ill health.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: visceral adipose tissue
time frame: time before intervention(T0) and after 12-weeks exercise intervention (T1)
description: measured by the body composition analyzer, which uses bioelectrical impedance analysis to estimate body composition.
measure: insulin resistance
time frame: time before intervention(T0) and after 12-weeks exercise intervention (T1)
description: Blood samples.Insulin resistance status will be checked by HOMA index at baseline and at exercise intervention after 12 weeks (HOMA index= insulin （μU/mL）× glucose（mmol/L）/22.5). The insulin level and fasting sugar from blood sample will be checked to calculate the insulin resistance.
arm group label: Aerobic exercise
arm group type: Experimental
description: Aerobic exercise is lasting for nearly 50 minutes each time, including warm-up and stretching for 10 minutes after exercise.
arm group label: Aerobic exercise combined with resistance exercise
arm group type: Experimental
description: Aerobic exercise is lasting for nearly 20 minutes each time, and add resistance exercise for 20 minutes. Additional warm-up 10 minutes and stretching for 5 minutes.
arm group label: Aerobic exercise combined with interval training
arm group type: Experimental
description: Aerobic exercise is lasting for nearly 20 minutes each time, and add moderal intensity interval training for 10 minutes. Additional warm-up 10 minutes and stretching for 15 minutes.
arm group label: Placebo
arm group type: Placebo Comparator
description: No exercise intervention.
intervention type: Behavioral
intervention name: exercise
description: different type of exercise
arm group label: Aerobic exercise
arm group label: Aerobic exercise combined with interval training
arm group label: Aerobic exercise combined with resistance exercise
intervention type: Behavioral
intervention name: No exercise intervention
description: No exercise intervention
arm group label: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Taiwan University
investigator full name: Yu-Hsuan Chang
investigator title: Principal Investigator, Nurse, ph D student
mesh term: Insulin Resistance
sharing ipd: No