<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/NCT02987491</url>
  </required_header>
  <id_info>
    <org_study_id>7605</org_study_id>
    <nct_id>NCT02987491</nct_id>
  </id_info>
  <brief_title>Exercise and Insulin Signaling in Human Skeletal Muscle</brief_title>
  <official_title>Exercise and Insulin Signaling in Human Skeletal Muscle</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obesity is associated with a decrease in skeletal muscle insulin sensitivity. Aerobic&#xD;
      exercise can increase insulin sensitivity in the few hours following exercise, however the&#xD;
      cellular mechanisms are not completely understood. The current project is to investigate&#xD;
      mechanisms of exercise improvements to skeletal muscle insulin sensitivity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Overview: We are investigating the mechanisms by which exercise improves the response&#xD;
      of skeletal muscle to insulin in lean and obese adults. Participants will complete 4 study&#xD;
      visits consisting of: 1) screening visit, 2) maximal exercise test visit, and then a&#xD;
      randomized order of 3) a resting metabolic study visit, and 4) an exercise metabolic study&#xD;
      visit. Metabolic study visits for resting and exercise conditions will be identical, other&#xD;
      than remaining sedentary or performing exercise. Skeletal muscle biopsy samples will be&#xD;
      collected during resting, immediately post-exercise and during insulin stimulated conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">June 28, 2018</completion_date>
  <primary_completion_date type="Actual">June 28, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Skeletal muscle insulin sensitivity</measure>
    <time_frame>2 hours following rest or exercise</time_frame>
    <description>Skeletal muscle insulin sensitivity will be measured by hyperinsulinemic-euglycemic clamp.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Insulin Sensitivity</condition>
  <condition>Obesity</condition>
  <condition>Sedentary Lifestyle</condition>
  <arm_group>
    <arm_group_label>Exercise Metabolic Study Day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will perform a single bout of moderate intensity exercise on a cycle ergometer for 60 minutes.&#xD;
A total of 3 muscle biopsies will be collected throughout the study day. Insulin sensitivity will be measured using a hyperinsulinemic-euglycemic clamp with glucose tracers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resting Metabolic Study Day</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will rest quietly in bed for 60 minutes and resting energy metabolism will be measured with a ventilated hood.&#xD;
A total of 3 muscle biopsies will be collected throughout the study day. Insulin sensitivity will be measured using a hyperinsulinemic-euglycemic clamp with glucose tracers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Participants will perform 2 metabolic study days of either resting or acute bout of cycling exercise in a randomized cross-over design.</description>
    <arm_group_label>Exercise Metabolic Study Day</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or Females&#xD;
&#xD;
          -  Aged 18-45 years&#xD;
&#xD;
          -  Normal weight (body mass index [BMI] 18-26 kg/m2) or obese (BMI 30-46 kg/m2)&#xD;
&#xD;
          -  Sedentary (&lt; 1 hour of planned physical activity per week for ≥ 6 months)&#xD;
&#xD;
          -  Weight stable (&lt; 2 kg change in body mass for ≥ 6 months)&#xD;
&#xD;
          -  Non-smokers (no tobacco or nicotine use for ≥ 1 year)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypertension (systolic blood pressure &gt;140 mmHg, diastolic blood pressure &gt; 90mmHg)&#xD;
&#xD;
          -  Chronic health condition including diabetes, cardiovascular disease, treated&#xD;
             hypertension, cancer, anemia, uncontrolled hyper- or hypothyroidism.&#xD;
&#xD;
          -  Pregnant, nursing, irregular menses or post-menopausal (if female)&#xD;
&#xD;
          -  Hyperglycemia (fasting glucose &gt;126 mg/dl)&#xD;
&#xD;
          -  Hypercholesterolemia (fasting LDL&gt;140mg/dl)&#xD;
&#xD;
          -  Hemoglobin &lt; 13.0 g/dl (males), &lt; 11.5 g/dl (females)&#xD;
&#xD;
          -  Compromised renal function (outside 135-145 mmol/L sodium, 3.5-5.1 mmol/L potassium)&#xD;
&#xD;
          -  Lidocaine allergy&#xD;
&#xD;
          -  Medications including β-blockers, angiotensin converting enzyme inhibitors, insulin,&#xD;
             thiazolidinediones, metformin, sulfonylureas, chronic non-steroidal anti-inflammatory&#xD;
             use, anti-coagulant (e.g. warfarin), current antibiotics, opiates, monoamine oxidase&#xD;
             inhibitors, benzodiazepines, or others that may impact the study outcomes&#xD;
&#xD;
          -  Any physical limitation that prevents a participant from safely completing the&#xD;
             exercise test&#xD;
&#xD;
          -  Due to the risks associated with the current protocol, individuals with a diminished&#xD;
             capacity to consent will be excluded. Similarly, due to the need for constant,&#xD;
             accurate participant monitoring during metabolic study activities, participants will&#xD;
             need to clearly understand verbal and written English. Participants who cannot clearly&#xD;
             understand verbal and written English will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew Robinson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oregon State University</name>
      <address>
        <city>Corvallis</city>
        <state>Oregon</state>
        <zip>97331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>August 23, 2019</last_update_submitted>
  <last_update_submitted_qc>August 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>exercise</keyword>
  <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>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 16, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT02987491/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02987491
org study id: 7605
nct id: NCT02987491
lead sponsor: 
has dmc: No
Obesity is associated with a decrease in skeletal muscle insulin sensitivity. Aerobic
      exercise can increase insulin sensitivity in the few hours following exercise, however the
      cellular mechanisms are not completely understood. The current project is to investigate
      mechanisms of exercise improvements to skeletal muscle insulin sensitivity.
Study Overview: We are investigating the mechanisms by which exercise improves the response
      of skeletal muscle to insulin in lean and obese adults. Participants will complete 4 study
      visits consisting of: 1) screening visit, 2) maximal exercise test visit, and then a
      randomized order of 3) a resting metabolic study visit, and 4) an exercise metabolic study
      visit. Metabolic study visits for resting and exercise conditions will be identical, other
      than remaining sedentary or performing exercise. Skeletal muscle biopsy samples will be
      collected during resting, immediately post-exercise and during insulin stimulated conditions.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Skeletal muscle insulin sensitivity
time frame: 2 hours following rest or exercise
description: Skeletal muscle insulin sensitivity will be measured by hyperinsulinemic-euglycemic clamp.
arm group label: Exercise Metabolic Study Day
arm group type: Experimental
description: Participants will perform a single bout of moderate intensity exercise on a cycle ergometer for 60 minutes.
A total of 3 muscle biopsies will be collected throughout the study day. Insulin sensitivity will be measured using a hyperinsulinemic-euglycemic clamp with glucose tracers.
arm group label: Resting Metabolic Study Day
arm group type: No Intervention
description: Participants will rest quietly in bed for 60 minutes and resting energy metabolism will be measured with a ventilated hood.
A total of 3 muscle biopsies will be collected throughout the study day. Insulin sensitivity will be measured using a hyperinsulinemic-euglycemic clamp with glucose tracers.
intervention type: Behavioral
intervention name: Exercise
description: Participants will perform 2 metabolic study days of either resting or acute bout of cycling exercise in a randomized cross-over design.
arm group label: Exercise Metabolic Study Day
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Matthew Robinson, PhD
role: Principal Investigator
affiliation: Oregon State University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Insulin Resistance
sharing ipd: No
provided document: 