<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/NCT02187965</url>
  </required_header>
  <id_info>
    <org_study_id>1107011060</org_study_id>
    <nct_id>NCT02187965</nct_id>
  </id_info>
  <brief_title>Impact of Muscle Fat Accumulation on the Genomic Profile of Skeletal Muscle in Older Adults</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Purdue University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Purdue University</source>
  <brief_summary>
    <textblock>
      Subjects were asked to come to the Purdue facilities after an overnight fast on 2 different&#xD;
      testing days for 2.5 hours each day. On one day the subjects participated in blood pressure&#xD;
      and body weight measurements as well as a muscle biopsy from the thigh. On the second day the&#xD;
      subjects underwent an MRI and MRS scan of the thigh and calf.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>MRI</measure>
    <time_frame>1 day</time_frame>
    <description>To determine the within day reproducibility of MRI scans for intermuscular adipose tissue (IMAT) quantification in older men and women.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>genomic profile</measure>
    <time_frame>1 day</time_frame>
    <description>To examine the influence of IMAT accumulation on the genomic profile of skeletal muscle of normal weight or obese adults.</description>
  </secondary_outcome>
  <enrollment type="Actual">11</enrollment>
  <condition>Intermuscular Adipose Tissue Quantification</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      muscle tissue, RNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        normal weight and obese older adults&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  60-80 years old, men and women, normal body weight or obese,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Certain medical conditions could have placed them at risk&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Purdue University</name>
      <address>
        <city>West Lafayette</city>
        <state>Indiana</state>
        <zip>47906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2011</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 10, 2014</last_update_submitted>
  <last_update_submitted_qc>July 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Purdue University</investigator_affiliation>
    <investigator_full_name>Wayne Campbell</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT02187965
org study id: 1107011060
nct id: NCT02187965
lead sponsor: 
Subjects were asked to come to the Purdue facilities after an overnight fast on 2 different
      testing days for 2.5 hours each day. On one day the subjects participated in blood pressure
      and body weight measurements as well as a muscle biopsy from the thigh. On the second day the
      subjects underwent an MRI and MRS scan of the thigh and calf.
observational model: Case-Only
time perspective: Cross-Sectional
measure: MRI
time frame: 1 day
description: To determine the within day reproducibility of MRI scans for intermuscular adipose tissue (IMAT) quantification in older men and women.
measure: genomic profile
time frame: 1 day
description: To examine the influence of IMAT accumulation on the genomic profile of skeletal muscle of normal weight or obese adults.
muscle tissue, RNA
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Purdue University
investigator full name: Wayne Campbell
investigator title: Professor