<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/NCT03023891</url>
  </required_header>
  <id_info>
    <org_study_id>161942</org_study_id>
    <secondary_id>5K23GM117395-03</secondary_id>
    <nct_id>NCT03023891</nct_id>
  </id_info>
  <brief_title>Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids</brief_title>
  <official_title>Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of General Medical Sciences (NIGMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effect of acute administration of oral prednisone in white blood&#xD;
      cells counts and glucose tolerance and the relationship of these measures with changes in&#xD;
      gene expression in healthy volunteers. White blood cells counts, glucose tolerance and gene&#xD;
      expression will be study before and after prednisone administration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prednisone is a potent anti-inflammatory drug that has large variability in its response. The&#xD;
      large inter individual variability in the response to prednisone has a genetic component, but&#xD;
      the genetic determinants of this variability remain unknown. We propose to use two relevant&#xD;
      phenotypes, changes in white blood cell counts and changes in glucose tolerance induced by in&#xD;
      vivo administration of prednisone, to characterize gene expression patterns and identify&#xD;
      variants that are involved in the in vivo response to prednisone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">January 10, 2019</primary_completion_date>
  <phase>Phase 1</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>White Blood Cell Counts</measure>
    <time_frame>baseline and within 4 and 8 hours after drug administration</time_frame>
    <description>White Blood Count at baseline (Visit 1) and within 4 to 8 hours after drug administration (Visit 2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glucose Tolerance Test: Area Under the Curve (AUC) for Plasma Glucose</measure>
    <time_frame>baseline and 4-8 hours after drug administration</time_frame>
    <description>AUC for plasma glucose during glucose tolerance test at baseline and 4-8 hours after drug administration.&#xD;
Plasma glucose levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glucose Tolerance Test: Area Under the Curve (AUC) for Insulin Levels</measure>
    <time_frame>baseline and 4-8 hours after drug administration</time_frame>
    <description>AUC for insulin levels during glucose tolerance test at baseline and 4-8 hours after prednisone.&#xD;
Insulin levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration administration (Visit 2).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glucose Tolerance Test: Area Under the Curve (AUC) for C-peptide Levels</measure>
    <time_frame>baseline and 4-8 hours after drug administration</time_frame>
    <description>AUC for C-peptide during glucose tolerance test at baseline and 4-8 hours after prednisone.&#xD;
C-peptide levels were measured at 0, 10, 20, 30, 60, 90, and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Glucocorticoids Toxicity</condition>
  <condition>Glucose Intolerance</condition>
  <arm_group>
    <arm_group_label>Prednisone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each participant will received a single dose of oral 60 mg of prednisone&#xD;
Visit 1: Baseline Oral Glucose Tolerance Test (OGTT) and White Blood Count (WBC) count Visit 2: Prednisone 60mg oral at 7am, OGGT and WBC count at 4 to 8 hours post drug</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>Prednisone 60 mg tablet once</description>
    <arm_group_label>Prednisone</arm_group_label>
    <other_name>generic, not applicable</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 45 years old (to exclude the effect of age on glucose tolerance);&#xD;
&#xD;
          -  BMI between 20 and 25 kg/m2 (to exclude individuals that are likely to have impaired&#xD;
             insulin response);&#xD;
&#xD;
          -  Normal fasting glucose;&#xD;
&#xD;
          -  Stable weight for three months before participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &gt;25kg/m2;&#xD;
&#xD;
          -  Fasting glucose ≥126 mg/dl&#xD;
&#xD;
          -  Shift work or disordered sleep (to exclude individuals with alterations in the&#xD;
             hypothalamus-adrenergic axis);&#xD;
&#xD;
          -  Any diseases;&#xD;
&#xD;
          -  Use of any medication regularly (including over-the-counter);&#xD;
&#xD;
          -  Previous exposure to glucocorticoids (within the last year);&#xD;
&#xD;
          -  Pregnancy&#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>Vivian K Kawai</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center -CRC</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <results_first_submitted>November 27, 2019</results_first_submitted>
  <results_first_submitted_qc>December 17, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 6, 2020</results_first_posted>
  <last_update_submitted>May 25, 2020</last_update_submitted>
  <last_update_submitted_qc>May 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Vivian Kawai</investigator_full_name>
    <investigator_title>Research Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>glucocorticoids</keyword>
  <keyword>efficacy</keyword>
  <keyword>metabolic toxicity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glucose Intolerance</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</mesh_term>
  </intervention_browse>
  <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>October 31, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT03023891/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 23, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT03023891/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>25 participants signed consent, 5 did not show up for screening and 2 failed screening. 18 participants started the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Prednisone</title>
          <description>Each participant will received a single dose of oral 60 mg of prednisone&#xD;
Prednisone: Prednisone 60 mg tablet once</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Prednisone</title>
          <description>Each participant will received a single dose of oral 60 mg of prednisone&#xD;
Prednisone: Prednisone 60 mg tablet once</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>White Blood Cell Counts</title>
        <description>White Blood Count at baseline (Visit 1) and within 4 to 8 hours after drug administration (Visit 2)</description>
        <time_frame>baseline and within 4 and 8 hours after drug administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prednisone</title>
            <description>Each participant will received a single dose of oral 60 mg of prednisone&#xD;
Prednisone: Prednisone 60 mg tablet once</description>
          </group>
        </group_list>
        <measure>
          <title>White Blood Cell Counts</title>
          <description>White Blood Count at baseline (Visit 1) and within 4 to 8 hours after drug administration (Visit 2)</description>
          <units>x10^3 cells/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1: baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.26" spread="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2: 4 to 8 hours post prednisone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.99" spread="1.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Glucose Tolerance Test: Area Under the Curve (AUC) for Plasma Glucose</title>
        <description>AUC for plasma glucose during glucose tolerance test at baseline and 4-8 hours after drug administration.&#xD;
Plasma glucose levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)</description>
        <time_frame>baseline and 4-8 hours after drug administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prednisone</title>
            <description>Each participant will received a single dose of oral 60 mg of prednisone&#xD;
Prednisone: Prednisone 60 mg tablet once</description>
          </group>
        </group_list>
        <measure>
          <title>Glucose Tolerance Test: Area Under the Curve (AUC) for Plasma Glucose</title>
          <description>AUC for plasma glucose during glucose tolerance test at baseline and 4-8 hours after drug administration.&#xD;
Plasma glucose levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)</description>
          <units>mg*min/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1: baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13530.56" spread="2002.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2: 4-8 hours post prednisone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20273.75" spread="3973.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Glucose Tolerance Test: Area Under the Curve (AUC) for Insulin Levels</title>
        <description>AUC for insulin levels during glucose tolerance test at baseline and 4-8 hours after prednisone.&#xD;
Insulin levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration administration (Visit 2).</description>
        <time_frame>baseline and 4-8 hours after drug administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prednisone</title>
            <description>Each participant will received a single dose of oral 60 mg of prednisone&#xD;
Prednisone: Prednisone 60 mg tablet once</description>
          </group>
        </group_list>
        <measure>
          <title>Glucose Tolerance Test: Area Under the Curve (AUC) for Insulin Levels</title>
          <description>AUC for insulin levels during glucose tolerance test at baseline and 4-8 hours after prednisone.&#xD;
Insulin levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration administration (Visit 2).</description>
          <units>μU*min/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1: baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5415.87" spread="2344.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2: 4-8 hours post prednisone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5466.55" spread="2382.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Glucose Tolerance Test: Area Under the Curve (AUC) for C-peptide Levels</title>
        <description>AUC for C-peptide during glucose tolerance test at baseline and 4-8 hours after prednisone.&#xD;
C-peptide levels were measured at 0, 10, 20, 30, 60, 90, and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)</description>
        <time_frame>baseline and 4-8 hours after drug administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prednisone</title>
            <description>Each participant will received a single dose of oral 60 mg of prednisone&#xD;
Prednisone: Prednisone 60 mg tablet once</description>
          </group>
        </group_list>
        <measure>
          <title>Glucose Tolerance Test: Area Under the Curve (AUC) for C-peptide Levels</title>
          <description>AUC for C-peptide during glucose tolerance test at baseline and 4-8 hours after prednisone.&#xD;
C-peptide levels were measured at 0, 10, 20, 30, 60, 90, and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)</description>
          <units>ng*min/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1: baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="493.89" spread="135.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2: 4-8 hours post prednisone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="449.41" spread="101.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Prednisone</title>
          <description>Each participant will received a single dose of oral 60 mg of prednisone&#xD;
Visit 1: Baseline Oral Glucose Tolerance Test (OGTT) and White Blood Count (WBC) count Visit 2: Prednisone 60 mg oral at 7am, OGGT and WBC count at 4 to 8 hours post drug&#xD;
Prednisone: Prednisone 60 mg tablet once</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Mild Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Mild anxiety and hyperactivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Tiredness, Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Vivian Kawai</name_or_title>
      <organization>Vanderbilt University Medical Center</organization>
      <phone>(615) 322-3304</phone>
      <email>vivian.k.kawai@vumc.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03023891
org study id: 161942
secondary id: 5K23GM117395-03
nct id: NCT03023891
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study evaluates the effect of acute administration of oral prednisone in white blood
      cells counts and glucose tolerance and the relationship of these measures with changes in
      gene expression in healthy volunteers. White blood cells counts, glucose tolerance and gene
      expression will be study before and after prednisone administration.
Prednisone is a potent anti-inflammatory drug that has large variability in its response. The
      large inter individual variability in the response to prednisone has a genetic component, but
      the genetic determinants of this variability remain unknown. We propose to use two relevant
      phenotypes, changes in white blood cell counts and changes in glucose tolerance induced by in
      vivo administration of prednisone, to characterize gene expression patterns and identify
      variants that are involved in the in vivo response to prednisone.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: White Blood Cell Counts
time frame: baseline and within 4 and 8 hours after drug administration
description: White Blood Count at baseline (Visit 1) and within 4 to 8 hours after drug administration (Visit 2)
measure: Glucose Tolerance Test: Area Under the Curve (AUC) for Plasma Glucose
time frame: baseline and 4-8 hours after drug administration
description: AUC for plasma glucose during glucose tolerance test at baseline and 4-8 hours after drug administration.
Plasma glucose levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)
measure: Glucose Tolerance Test: Area Under the Curve (AUC) for Insulin Levels
time frame: baseline and 4-8 hours after drug administration
description: AUC for insulin levels during glucose tolerance test at baseline and 4-8 hours after prednisone.
Insulin levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration administration (Visit 2).
measure: Glucose Tolerance Test: Area Under the Curve (AUC) for C-peptide Levels
time frame: baseline and 4-8 hours after drug administration
description: AUC for C-peptide during glucose tolerance test at baseline and 4-8 hours after prednisone.
C-peptide levels were measured at 0, 10, 20, 30, 60, 90, and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)
arm group label: Prednisone
arm group type: Experimental
description: Each participant will received a single dose of oral 60 mg of prednisone
Visit 1: Baseline Oral Glucose Tolerance Test (OGTT) and White Blood Count (WBC) count Visit 2: Prednisone 60mg oral at 7am, OGGT and WBC count at 4 to 8 hours post drug
intervention type: Drug
intervention name: Prednisone
description: Prednisone 60 mg tablet once
arm group label: Prednisone
other name: generic, not applicable
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Vivian K Kawai
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Vivian Kawai
investigator title: Research Assistant Professor
mesh term: Glucose Intolerance
mesh term: Prednisone
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 