<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/NCT03037216</url>
  </required_header>
  <id_info>
    <org_study_id>2016-34</org_study_id>
    <nct_id>NCT03037216</nct_id>
  </id_info>
  <brief_title>Investigation of Exercise Training-Induced Myokines and Adipolkines in Humans</brief_title>
  <official_title>Investigation of Exercise Training-Induced Myokines and Adipolkines in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joslin Diabetes Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Daiichi Sankyo, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Joslin Diabetes Center</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to find out whether exercise training leads to changes in the&#xD;
      blood that are produced by exercised muscles and if these changes produce new hormones that&#xD;
      affect the body's regulation of sugar and body weight.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 15, 2016</start_date>
  <completion_date type="Actual">February 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</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>
    <intervention_model_description>Single Group Assignment</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in circulating proteins in the blood.</measure>
    <time_frame>Baseline vs. Post 10 Week Training.</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Experimental Exercise-Training Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will undergo a 10-week aerobic exercise protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise Intervention</intervention_name>
    <description>10 Week aerobic exercise training</description>
    <arm_group_label>Experimental Exercise-Training Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Age between 18-35. Body mass index (BMI) must be ≥18.5 and ≤27 kg/m2. HbA1c values ≤5.7%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 and &gt;50&#xD;
&#xD;
          -  HbA1c ≥ 5.7%; heart or lung disease&#xD;
&#xD;
          -  acute systemic infection accompanied by fever, body aches, or swollen lymph glands&#xD;
&#xD;
          -  BMI &gt; 27 kg/m2&#xD;
&#xD;
          -  current dieting or weight loss efforts&#xD;
&#xD;
          -  current pregnancy or breastfeeding&#xD;
&#xD;
          -  known history of HIV/AIDS; cancer&#xD;
&#xD;
          -  biochemical evidence of renal or hepatic dysfunction; renal or liver disease&#xD;
             demyelinating diseases such as multiple sclerosis or amyotrophic lateral sclerosis&#xD;
&#xD;
          -  recent blood donation&#xD;
&#xD;
          -  clinical history of stroke&#xD;
&#xD;
          -  hypertension (systolic &gt; 140 mmHg or diastolic &gt; 90 mmHg)&#xD;
&#xD;
          -  type 1 or 2 diabetes; inability to exercise at 50% of predicted heart rate (HR)&#xD;
             reserve at baseline&#xD;
&#xD;
          -  Participants taking beta-blockers Participants who screen positive for The American&#xD;
             Heart Association's contraindications to exercise testing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laurie J Goodyear, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Joslin Diabetes Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Joslin Diabetes Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>August 19, 2020</last_update_submitted>
  <last_update_submitted_qc>August 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise</keyword>
  <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/NCT03037216
org study id: 2016-34
nct id: NCT03037216
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to find out whether exercise training leads to changes in the
      blood that are produced by exercised muscles and if these changes produce new hormones that
      affect the body's regulation of sugar and body weight.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Changes in circulating proteins in the blood.
time frame: Baseline vs. Post 10 Week Training.
arm group label: Experimental Exercise-Training Intervention
arm group type: Experimental
description: Subjects will undergo a 10-week aerobic exercise protocol.
intervention type: Other
intervention name: Exercise Intervention
description: 10 Week aerobic exercise training
arm group label: Experimental Exercise-Training Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Laurie J Goodyear, PhD
role: Principal Investigator
affiliation: Joslin Diabetes Center
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No