<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/NCT03240978</url>
  </required_header>
  <id_info>
    <org_study_id>UW-15370</org_study_id>
    <nct_id>NCT03240978</nct_id>
  </id_info>
  <brief_title>Exercise Intervention for the Prevention of Prediabetes in Overweight Chinese</brief_title>
  <official_title>An Interventional Study for the Effects of Physical Exercise on the Prevention of Prediabetes in Overweight Chinese: Role of Gut Microbiota and Adipokines</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</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>
      Overweight/obese Chinese and prediabetes will be recruited and divided into three age-matched&#xD;
      groups including high intensity exercise, moderate intensity exercise, and non-exercise&#xD;
      groups. The exercise program will consist of three sessions per week over the course of 12&#xD;
      weeks, under the supervision of our in-house exercise specialists and physiologists. The&#xD;
      effects of exercise on glucose and lipid profiles, insulin sensitivity and adiposity will be&#xD;
      evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      60 Chinese men aged between 21 and 60 years old with overweight/obesity (25 kg/m2 &lt;BMI &lt; 32.5&#xD;
      kg/m2) and prediabetes will be recruited.The participants will be divided into three&#xD;
      age-matched groups (n=20 in each group),including high intensity exercise, moderate intensity&#xD;
      exercise, and non-exercise groups. The suitability of each participant for physical exercise&#xD;
      will be assessed by an in-house exercise specialist, based on parameters of blood pressure,&#xD;
      strength, cardiovascular fitness, balance, flexibility. The exercise program will consist of&#xD;
      three sessions per week over the course of 12 weeks, under the supervision of our in-house&#xD;
      exercise specialists and physiologists. Each session will comprise of warm-up, resistance and&#xD;
      aerobic training components and a cool-down. The high intensity training (aerobic combined&#xD;
      with strength training) will consist of six exercises of three sets each, with each exercise&#xD;
      set at an intensity of 6 to 10 repetition maximum. Intensity, volume and exercise selection&#xD;
      will be varied both within the week and over the 12 week program in a periodised system&#xD;
      designed to maximize muscle hypertrophy and strength gain. Exercise intensity will be at 60&#xD;
      to 80% of estimated heart rate maximum. Moderate intensity training (Aerobic training) will&#xD;
      be conducted on a variety of ergometers including treadmill, cycle, rowing and cross training&#xD;
      machines. The non-exercise group (delayed group) will be used as placebo control, and will&#xD;
      participate in the training group at the later stage.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of fasting glucose</measure>
    <time_frame>change from baseline fasting glucose level at 12 weeks</time_frame>
    <description>fasting glucose level</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>alterations of gut microbiome</measure>
    <time_frame>before, 4 weeks and 12 weeks after exercise training</time_frame>
    <description>advanced metagenomics to identify gut microbiota species altered by exercise training</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of non-responsiveness in the alleviation of insulin resistance to exercise intervention</measure>
    <time_frame>before and after 12 weeks after exercise training</time_frame>
    <description>Participants in the exercise arms are further classified into responders or non-responsders, depending on whether they could demonstrate a decrease of insulin resistance index (HOMA-IR) greater than 2-fold technical error, which is a threshold for true physiological adaptation. HOMA-IR is calculated using homeostasis model assessment methods, defined as fasting insulin (μU/mL)×fasting glucose (mmol/L)/22.5.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>PreDiabetes</condition>
  <condition>Insulin Sensitivity</condition>
  <arm_group>
    <arm_group_label>High intensity intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise intervention at 70 to 80% of estimated heart rate maximum for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate intensity intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise intervention at 50 to 70% of estimated heart rate maximum for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-exercise group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will not receive any type of exercise training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>exercise intervention</intervention_name>
    <description>A period of 12-week exercise intervention under the supervision of exercise specialists will be conducted.</description>
    <arm_group_label>High intensity intervention</arm_group_label>
    <arm_group_label>Moderate intensity intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - overweight/obese Chinese man (25 kg/m2&lt;BMI&lt;32.5 kg/m2) aged between 21 and 60 years old;&#xD;
        prediabetes, impaired glucose tolerance (mean 2-h blood glucose ≥7.8 and ≤11.1 mmol/l after&#xD;
        a 75-g oral glucose challenge) or impaired fasting glucose (mean fasting blood glucose ≥6.1&#xD;
        mmol/l and ≤7.0 mmol/l and HbA1c levels between 5.7% and 6.4%).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - any neurological, musculoskeletal or cardio respiratory condition, which would put them&#xD;
        at risk during exercise or inhibit their ability to adapt to an exercise program; any&#xD;
        subject participated in a regular vigorous exercise and/or diet program more than 2 times&#xD;
        per week in the 3 months prior to recruitment; any subject who is taking medicine,&#xD;
        especially antibiotics in the past week prior to study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aimin Xu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Medicine, The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Medicine</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</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>Overweight</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Glucose Intolerance</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/NCT03240978
org study id: UW-15370
nct id: NCT03240978
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Overweight/obese Chinese and prediabetes will be recruited and divided into three age-matched
      groups including high intensity exercise, moderate intensity exercise, and non-exercise
      groups. The exercise program will consist of three sessions per week over the course of 12
      weeks, under the supervision of our in-house exercise specialists and physiologists. The
      effects of exercise on glucose and lipid profiles, insulin sensitivity and adiposity will be
      evaluated.
60 Chinese men aged between 21 and 60 years old with overweight/obesity (25 kg/m2 <BMI < 32.5
      kg/m2) and prediabetes will be recruited.The participants will be divided into three
      age-matched groups (n=20 in each group),including high intensity exercise, moderate intensity
      exercise, and non-exercise groups. The suitability of each participant for physical exercise
      will be assessed by an in-house exercise specialist, based on parameters of blood pressure,
      strength, cardiovascular fitness, balance, flexibility. The exercise program will consist of
      three sessions per week over the course of 12 weeks, under the supervision of our in-house
      exercise specialists and physiologists. Each session will comprise of warm-up, resistance and
      aerobic training components and a cool-down. The high intensity training (aerobic combined
      with strength training) will consist of six exercises of three sets each, with each exercise
      set at an intensity of 6 to 10 repetition maximum. Intensity, volume and exercise selection
      will be varied both within the week and over the 12 week program in a periodised system
      designed to maximize muscle hypertrophy and strength gain. Exercise intensity will be at 60
      to 80% of estimated heart rate maximum. Moderate intensity training (Aerobic training) will
      be conducted on a variety of ergometers including treadmill, cycle, rowing and cross training
      machines. The non-exercise group (delayed group) will be used as placebo control, and will
      participate in the training group at the later stage.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: change of fasting glucose
time frame: change from baseline fasting glucose level at 12 weeks
description: fasting glucose level
measure: alterations of gut microbiome
time frame: before, 4 weeks and 12 weeks after exercise training
description: advanced metagenomics to identify gut microbiota species altered by exercise training
measure: rate of non-responsiveness in the alleviation of insulin resistance to exercise intervention
time frame: before and after 12 weeks after exercise training
description: Participants in the exercise arms are further classified into responders or non-responsders, depending on whether they could demonstrate a decrease of insulin resistance index (HOMA-IR) greater than 2-fold technical error, which is a threshold for true physiological adaptation. HOMA-IR is calculated using homeostasis model assessment methods, defined as fasting insulin (μU/mL)×fasting glucose (mmol/L)/22.5.
arm group label: High intensity intervention
arm group type: Experimental
description: Exercise intervention at 70 to 80% of estimated heart rate maximum for 12 weeks.
arm group label: Moderate intensity intervention
arm group type: Experimental
description: Exercise intervention at 50 to 70% of estimated heart rate maximum for 12 weeks.
arm group label: non-exercise group
arm group type: No Intervention
description: Participants will not receive any type of exercise training.
intervention type: Behavioral
intervention name: exercise intervention
description: A period of 12-week exercise intervention under the supervision of exercise specialists will be conducted.
arm group label: High intensity intervention
arm group label: Moderate intensity intervention
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aimin Xu
role: Principal Investigator
affiliation: Department of Medicine, The University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Sponsor
mesh term: Overweight
mesh term: Insulin Resistance
mesh term: Prediabetic State
mesh term: Glucose Intolerance
sharing ipd: No