<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/NCT04466566</url>
  </required_header>
  <id_info>
    <org_study_id>20-003984</org_study_id>
    <nct_id>NCT04466566</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Effect of Genetic Variation on Beta-cell Function During Fasting and Hyperglycemia in Nondiabetics</brief_title>
  <official_title>Effect of Genetic Variation in the GLP-1 Receptor on Beta-cell Function During Fasting and Hyperglycemia in Nondiabetic Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adrian Vella</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The GLP-1 receptor (GLP1R) gene is found on the beta cells of the pancreas. Its role is in&#xD;
      the control of blood sugar level by enhancing insulin secretion from the pancreas after&#xD;
      eating a meal. The purpose of this research study to find out how genetic variations in GLP1R&#xD;
      alter insulin secretion, in the fasting state and when blood sugars levels are elevated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 17, 2022</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
  <phase>Phase 3</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>Insulin secretion quantified using the minimal model to generate an index of beta-cell responsivity (Φ)</measure>
    <time_frame>This will be calculated from the 0-180 minute data of the study</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glucagon secretion measured by immunoassay</measure>
    <time_frame>This will be averaged over the 0-180 minute data of the study</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline will be infused during the study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exendin-9,39</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Exendin-9,39 will be infused during the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Saline will serve as the control</description>
    <arm_group_label>Saline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Exendin-9,39</intervention_name>
    <description>Exendin-9,39 will block the GLP-1 receptor</description>
    <arm_group_label>Exendin-9,39</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  40 nondiabetic subjects will be recruited.&#xD;
&#xD;
          -  20 subjects with the AA genotype at rs3765467 and remainder will have the GG genotype.&#xD;
&#xD;
          -  Individuals encompassing the age span of 25-65 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals under 25 and over 65 years of age.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adrian Vella, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeanette Laugen</last_name>
      <phone>507-255-5110</phone>
      <email>laugen.jeanette@mayo.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>November 21, 2022</last_update_submitted>
  <last_update_submitted_qc>November 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Adrian Vella</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperglycemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04466566
org study id: 20-003984
nct id: NCT04466566
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The GLP-1 receptor (GLP1R) gene is found on the beta cells of the pancreas. Its role is in
      the control of blood sugar level by enhancing insulin secretion from the pancreas after
      eating a meal. The purpose of this research study to find out how genetic variations in GLP1R
      alter insulin secretion, in the fasting state and when blood sugars levels are elevated.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Insulin secretion quantified using the minimal model to generate an index of beta-cell responsivity (Φ)
time frame: This will be calculated from the 0-180 minute data of the study
measure: Glucagon secretion measured by immunoassay
time frame: This will be averaged over the 0-180 minute data of the study
arm group label: Saline
arm group type: Placebo Comparator
description: Saline will be infused during the study
arm group label: Exendin-9,39
arm group type: Active Comparator
description: Exendin-9,39 will be infused during the study
intervention type: Other
intervention name: Saline
description: Saline will serve as the control
arm group label: Saline
intervention type: Biological
intervention name: Exendin-9,39
description: Exendin-9,39 will block the GLP-1 receptor
arm group label: Exendin-9,39
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Adrian Vella, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
status: Recruiting
contact: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Sponsor-Investigator
investigator affiliation: Mayo Clinic
investigator full name: Adrian Vella
investigator title: Principal Investigator
mesh term: Hyperglycemia
sharing ipd: No