<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/NCT03839511</url>
  </required_header>
  <id_info>
    <org_study_id>2018-050-PBRC HYPOCLAMP</org_study_id>
    <nct_id>NCT03839511</nct_id>
  </id_info>
  <brief_title>Use of a Hyperinsulinemic-hypyglycemic Clamp to Study Hypoglycemia: a Method Development Study</brief_title>
  <official_title>Use of a Hyperinsulinemic-hypyglycemic Clamp to Study Hypoglycemia: a Method Development Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pennington Biomedical Research Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A hyperinsulinemic-hypoglycemic clamp is an experimental procedure, which allows for&#xD;
      hypoglycemia to be studied in a safe and controlled manner. The goal of this study is to&#xD;
      establish the hyperinsulinemic-hypoglycemic clamp procedure at Pennington Biomedical Research&#xD;
      Center in order to apply the knowledge gained to future studies which will determine the&#xD;
      efficacy of our biomarker for predicting susceptibility to hypoglycemia. Additionally, our&#xD;
      use of continuous glucose monitoring (CGM) during the clamp procedure will provide novel data&#xD;
      regarding the accuracy of CGM during hypoglycemic conditions in a controlled research&#xD;
      setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2018</start_date>
  <completion_date type="Actual">February 8, 2019</completion_date>
  <primary_completion_date type="Actual">February 8, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Epinephrine Levels</measure>
    <time_frame>90 minute interval following initiation of insulin infusion</time_frame>
    <description>This value represents the average peak epinephrine value measured during the hypoglycemic clamp procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CGM Glucose</measure>
    <time_frame>90 minute interval following initiation of insulin infusion</time_frame>
    <description>This value represents the average glucose values measured via continuous glucose monitoring during the hypoglycemic clamp procedure</description>
  </secondary_outcome>
  <enrollment type="Actual">4</enrollment>
  <condition>Diabetes</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hyperinsulinemic-hypoglycemic clamp</intervention_name>
    <description>Subjects will arrive at the inpatient unit in the morning after at least a 10 hour overnight fast. Upon arrival to PBRC, participants will be admitted to the inpatient unit. Following measurement of weight, vitals, and pregnancy test (women only), the 4-hour hypoglycemic clamp procedure (30 minute baseline, 120 minute insulin infusion, and 90 minute recovery) will be performed. Upon completion of the clamp procedure, participants will be provided lunch (Standard American Diet). Following lunch, the CGM sensor will be removed and pending a stable blood glucose level in the normal range, the participant will be discharged from the inpatient unit. This completes the study.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We will enroll up to 8 healthy men or women (goal n=3 completers) in this method&#xD;
        development study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female&#xD;
&#xD;
          -  Ages 18-40 years&#xD;
&#xD;
          -  BMI between 20 kg/m2 and 30 kg/m2 (±0.5 kg/m2 will be accepted)&#xD;
&#xD;
          -  Medically cleared for participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of clinically diagnosed diabetes or a fasting blood glucose &gt;126 mg/dL&#xD;
&#xD;
          -  Average screening blood pressure &gt;140/90 mmHg&#xD;
&#xD;
          -  History of cardiovascular disease&#xD;
&#xD;
          -  Pregnant, planning to become pregnant, or breastfeeding&#xD;
&#xD;
          -  Based on the investigative team's clinical judgement, a subject may not be appropriate&#xD;
             for participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808-4124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <results_first_submitted>June 28, 2021</results_first_submitted>
  <results_first_submitted_qc>July 25, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 19, 2021</results_first_posted>
  <last_update_submitted>July 25, 2021</last_update_submitted>
  <last_update_submitted_qc>July 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>David McDougal</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoglycemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoglycemic Agents</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03839511/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Participants will undergo a hyperinsulinemic-hypoglycemic clamp procedure</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </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>
      <population>All participants</population>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Participants will undergo a hyperinsulinemic-hypoglycemic clamp procedure</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32" spread="6.3"/>
                  </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="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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>Fasting blood glucose</title>
          <description>Overnight fasting blood glucose at screening</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="86" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Peak Epinephrine Levels</title>
        <description>This value represents the average peak epinephrine value measured during the hypoglycemic clamp procedure</description>
        <time_frame>90 minute interval following initiation of insulin infusion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Participants will undergo a hyperinsulinemic-hypoglycemic clamp procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Epinephrine Levels</title>
          <description>This value represents the average peak epinephrine value measured during the hypoglycemic clamp procedure</description>
          <units>pg/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="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="609" spread="280"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CGM Glucose</title>
        <description>This value represents the average glucose values measured via continuous glucose monitoring during the hypoglycemic clamp procedure</description>
        <time_frame>90 minute interval following initiation of insulin infusion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Participants will undergo a hyperinsulinemic-hypoglycemic clamp procedure</description>
          </group>
        </group_list>
        <measure>
          <title>CGM Glucose</title>
          <description>This value represents the average glucose values measured via continuous glucose monitoring during the hypoglycemic clamp procedure</description>
          <units>mg/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="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Participants will undergo a hyperinsulinemic-hypoglycemic clamp procedure</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="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Dr. David McDougal</name_or_title>
      <organization>Pennington Biomedical Research Center</organization>
      <phone>2257630278</phone>
      <email>DAVID.MCDOUGAL@PBRC.EDU</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/NCT03839511
org study id: 2018-050-PBRC HYPOCLAMP
nct id: NCT03839511
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A hyperinsulinemic-hypoglycemic clamp is an experimental procedure, which allows for
      hypoglycemia to be studied in a safe and controlled manner. The goal of this study is to
      establish the hyperinsulinemic-hypoglycemic clamp procedure at Pennington Biomedical Research
      Center in order to apply the knowledge gained to future studies which will determine the
      efficacy of our biomarker for predicting susceptibility to hypoglycemia. Additionally, our
      use of continuous glucose monitoring (CGM) during the clamp procedure will provide novel data
      regarding the accuracy of CGM during hypoglycemic conditions in a controlled research
      setting.
observational model: Cohort
time perspective: Prospective
measure: Peak Epinephrine Levels
time frame: 90 minute interval following initiation of insulin infusion
description: This value represents the average peak epinephrine value measured during the hypoglycemic clamp procedure
measure: CGM Glucose
time frame: 90 minute interval following initiation of insulin infusion
description: This value represents the average glucose values measured via continuous glucose monitoring during the hypoglycemic clamp procedure
intervention type: Procedure
intervention name: Hyperinsulinemic-hypoglycemic clamp
description: Subjects will arrive at the inpatient unit in the morning after at least a 10 hour overnight fast. Upon arrival to PBRC, participants will be admitted to the inpatient unit. Following measurement of weight, vitals, and pregnancy test (women only), the 4-hour hypoglycemic clamp procedure (30 minute baseline, 120 minute insulin infusion, and 90 minute recovery) will be performed. Upon completion of the clamp procedure, participants will be provided lunch (Standard American Diet). Following lunch, the CGM sensor will be removed and pending a stable blood glucose level in the normal range, the participant will be discharged from the inpatient unit. This completes the study.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: David McDougal
investigator title: Assistant Professor
mesh term: Hypoglycemia
mesh term: Hypoglycemic Agents
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 