<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/NCT04416191</url>
  </required_header>
  <id_info>
    <org_study_id>130232</org_study_id>
    <nct_id>NCT04416191</nct_id>
  </id_info>
  <brief_title>Immune Cells During Disuse and Recovery</brief_title>
  <official_title>Muscle Immune Cells During Disuse and Recovery in Aging and Metabolic Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</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>
      This is an interventional study enrolling healthy individuals aged 18-35 and 60-85 to&#xD;
      understand the recovery of muscle health following a period of inactivity. The enrollment&#xD;
      goal is 45 participants. The study will occur over the course of 1-2 months where&#xD;
      participants will undergo testing before and after a 2-week limb immobilization period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Visit 1 (Pre-testing)- After signing a consent form, participants will undergo a blood&#xD;
      screening and an oral glucose tolerance test. After the visit, participants will be provided&#xD;
      with a step activity monitor to track their level of activity. A dietary assessment will also&#xD;
      be determined.&#xD;
&#xD;
      Visit 2- At a later time, the participant will return to the research center for a biopsy,&#xD;
      blood draw, body composition scan, MRI and muscle strength testing.&#xD;
&#xD;
      2-week leg immobilization period- After visit 2 , the participant will return home and&#xD;
      undergo a 14-day leg immobilization period using the equipment and instructions provided at&#xD;
      visit 2.&#xD;
&#xD;
      Visit 3- During the limb immobilization period, participant will return to the research&#xD;
      center for a single blood draw.&#xD;
&#xD;
      Visit 4- At the end of the 2-week limb immobilization period, the participant will return to&#xD;
      the research center to undergo another biopsy, blood draw, body composition scan, MRI and&#xD;
      muscle strength testing.&#xD;
&#xD;
      Visit 5- 2 days after the 2-week limb immobilization period, the participant will return for&#xD;
      a biopsy and blood draw.&#xD;
&#xD;
      Visit 6- 7 days after the 2-week limb immobilization period, the participant will be asked to&#xD;
      return for a final biopsy, blood draw, body composition scan, MRI and muscle strength&#xD;
      testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 15, 2022</start_date>
  <completion_date type="Anticipated">April 30, 2028</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2027</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>Participants will be tested before a 2-week limb immobilization period</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Thigh Muscle Volume</measure>
    <time_frame>baseline and after 2 weeks of leg immobilization</time_frame>
    <description>change in thigh muscle volume as determined by MRI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Leg Muscle Strength</measure>
    <time_frame>baseline and after 2 weeks of leg immobilization</time_frame>
    <description>change in isometric leg extension strength as determined by a isokinetic dynamometer</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Muscle Disuse</condition>
  <arm_group>
    <arm_group_label>Limb immobilization</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will undergo a 2-week leg immobilization period</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Limb immobilization</intervention_name>
    <description>Participants will undergo a 2-week period of leg immobilization</description>
    <arm_group_label>Limb immobilization</arm_group_label>
    <other_name>Muscle Disuse</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 18-35 and 60-85 yrs&#xD;
&#xD;
          2. Ability to sign informed consent&#xD;
&#xD;
          3. Free-living, prior to admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of cardiovascular disease (e.g., CHF, CAD, right-to-left shunt)&#xD;
&#xD;
          -  History of endocrine or metabolic disease such as hypo/hyperthyroidism and diabetes&#xD;
&#xD;
          -  History of kidney disease or failure&#xD;
&#xD;
          -  Vascular disease&#xD;
&#xD;
          -  Risk of DVT including family history of thrombophilia, DVT, pulmonary emboli,&#xD;
             myeloproliferative diseases including polycythemia (Hb&gt;18 g/dL) or thrombocytosis&#xD;
             (platelets&gt;400x103/mL), and connective tissue diseases (positive lupus anticoagulant),&#xD;
             hyperhomocystinemia, deficiencies of factor V Leiden, proteins S and C, and&#xD;
             antithrombine III&#xD;
&#xD;
          -  Use of anticoagulant therapy (e.g., Coumadin, heparin)&#xD;
&#xD;
          -  Elevated systolic pressure &gt;150 or a diastolic blood pressure &gt; 100&#xD;
&#xD;
          -  Implanted electronic devices (e.g., pacemakers, electronic infusion pumps,&#xD;
             stimulators)&#xD;
&#xD;
          -  Cancer or history of successfully treated cancer (less than 1 year) other than basal&#xD;
             cell carcinoma&#xD;
&#xD;
          -  Currently on a weight-loss diet&#xD;
&#xD;
          -  Chronic systemic corticosteroid use (≥ 2 weeks) within 4 weeks of enrollment and for&#xD;
             study duration (intra-articular/topical/inhaled therapeutic or physiologic doses of&#xD;
             corticosteroids are permitted)&#xD;
&#xD;
          -  Androgens or growth hormone within 6 months of enrollment and for study duration&#xD;
             (topical physiologic androgen replacement is permitted)&#xD;
&#xD;
          -  History of stroke with motor disability&#xD;
&#xD;
          -  A recent history (&lt;12 months) of GI bleed&#xD;
&#xD;
          -  History of liver disease&#xD;
&#xD;
          -  History of respiratory disease (acute upper respiratory infection, history of chronic&#xD;
             lung disease)&#xD;
&#xD;
          -  Pregnancy as determined by a pregnancy test&#xD;
&#xD;
          -  Any staff members who report directly to an investigator or who report to someone who&#xD;
             reports directly to an investigator.&#xD;
&#xD;
          -  Any other condition or event considered exclusionary by the PI and faculty physician&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Micah Drummond, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Micah Drummond, PhD</last_name>
    <phone>801-213-2737</phone>
    <email>micah.drummond@hsc.utah.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>The University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Micah Drummond, PhD</last_name>
      <phone>801-587-7764</phone>
    </contact>
    <contact_backup>
      <email>micah.drummond@hsc.utah.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Micah Drummond</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>March 13, 2023</last_update_submitted>
  <last_update_submitted_qc>March 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Micah Drummond</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan has been put into place</ipd_description>
  </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/NCT04416191
org study id: 130232
nct id: NCT04416191
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is an interventional study enrolling healthy individuals aged 18-35 and 60-85 to
      understand the recovery of muscle health following a period of inactivity. The enrollment
      goal is 45 participants. The study will occur over the course of 1-2 months where
      participants will undergo testing before and after a 2-week limb immobilization period.
Visit 1 (Pre-testing)- After signing a consent form, participants will undergo a blood
      screening and an oral glucose tolerance test. After the visit, participants will be provided
      with a step activity monitor to track their level of activity. A dietary assessment will also
      be determined.

      Visit 2- At a later time, the participant will return to the research center for a biopsy,
      blood draw, body composition scan, MRI and muscle strength testing.

      2-week leg immobilization period- After visit 2 , the participant will return home and
      undergo a 14-day leg immobilization period using the equipment and instructions provided at
      visit 2.

      Visit 3- During the limb immobilization period, participant will return to the research
      center for a single blood draw.

      Visit 4- At the end of the 2-week limb immobilization period, the participant will return to
      the research center to undergo another biopsy, blood draw, body composition scan, MRI and
      muscle strength testing.

      Visit 5- 2 days after the 2-week limb immobilization period, the participant will return for
      a biopsy and blood draw.

      Visit 6- 7 days after the 2-week limb immobilization period, the participant will be asked to
      return for a final biopsy, blood draw, body composition scan, MRI and muscle strength
      testing.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Participants will be tested before a 2-week limb immobilization period
primary purpose: Basic Science
masking: None (Open Label)
measure: Thigh Muscle Volume
time frame: baseline and after 2 weeks of leg immobilization
description: change in thigh muscle volume as determined by MRI
measure: Leg Muscle Strength
time frame: baseline and after 2 weeks of leg immobilization
description: change in isometric leg extension strength as determined by a isokinetic dynamometer
arm group label: Limb immobilization
arm group type: Other
description: Participants will undergo a 2-week leg immobilization period
intervention type: Other
intervention name: Limb immobilization
description: Participants will undergo a 2-week period of leg immobilization
arm group label: Limb immobilization
other name: Muscle Disuse
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Micah Drummond, PhD
role: Principal Investigator
affiliation: University of Utah
last name: Micah Drummond, PhD
phone: 801-213-2737
email: micah.drummond@hsc.utah.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Micah Drummond
investigator title: Associate Professor
sharing ipd: No
ipd description: No plan has been put into place