<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/NCT04466618</url>
  </required_header>
  <id_info>
    <org_study_id>20-003993</org_study_id>
    <nct_id>NCT04466618</nct_id>
  </id_info>
  <brief_title>Endogenous GLP-1 Secretion on Islet Function in People With and Without Type 2 Diabetes</brief_title>
  <official_title>To Determine the Effect of Endogenous GLP-1 Secretion on Islet Function in People With and Without Type 2 Diabetes</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>
      GLP-1 is a hormone made by the body that promotes the production of insulin in response to&#xD;
      eating. However, there is increasing evidence that this hormone might help support the body's&#xD;
      ability to produce insulin when diabetes develops. The purpose of this study is to determine&#xD;
      the effect of endogenous GLP-1 secretion on insulin secretion in people with and without type&#xD;
      2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2021</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 15, 2022</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glucagon Concentrations</measure>
    <time_frame>Average concentration over the 0-180minutes of study</time_frame>
    <description>Measured by immunoassay</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Healthy</condition>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline infusion</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 infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline + Intralipid/Heparin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Induction of acute insulin resistance during Saline infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exendin-9,39 + Intralipid/Heparin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Induction of acute insulin resistance during Exendin-9,39 infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Saline infused during the study</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 infused during the study</description>
    <arm_group_label>Exendin-9,39</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Saline + Intralipid/Heparin</intervention_name>
    <description>Saline infused during acute insulin resistance</description>
    <arm_group_label>Saline + Intralipid/Heparin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Exendin-9,39 + Intralipid/Heparin</intervention_name>
    <description>Exendin-9,39 infused during acute insulin resistance</description>
    <arm_group_label>Exendin-9,39 + Intralipid/Heparin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria - non-diabetic subjects:&#xD;
&#xD;
          -  Weight-stable, non-diabetic subjects&#xD;
&#xD;
        Exclusion Criteria - non-diabetic subjects:&#xD;
&#xD;
          -  Age &lt; 25 or &gt; 65 years (to avoid studying subjects who could have latent type 1&#xD;
             diabetes, or the effects of age extremes in subjects with normal or impaired fasting&#xD;
             glucose).&#xD;
&#xD;
          -  HbA1c ≥ 6.5%&#xD;
&#xD;
          -  Use of glucose-lowering agents.&#xD;
&#xD;
          -  For female subjects: positive pregnancy test at the time of enrollment or study&#xD;
&#xD;
          -  History of prior upper abdominal surgery such as adjustable gastric banding,&#xD;
             pyloroplasty and vagotomy.&#xD;
&#xD;
          -  Active systemic illness or malignancy.&#xD;
&#xD;
          -  Symptomatic macrovascular or microvascular disease.&#xD;
&#xD;
        Inclusion criteria - diabetic subjects:&#xD;
&#xD;
          -  Weight-stable, diabetic subjects treated with diet and lifestyle alone or with&#xD;
             metformin monotherapy&#xD;
&#xD;
        Exclusion Criteria - diabetic subjects:&#xD;
&#xD;
          -  Age &lt; 25 or &gt; 65 years (to avoid studying subjects who could have latent type 1&#xD;
             diabetes, or the effects of age extremes in subjects with normal or impaired fasting&#xD;
             glucose).&#xD;
&#xD;
          -  Use of any glucose-lowering agent other than metformin.&#xD;
&#xD;
          -  2 or more fasting glucose values &gt; 250mg/dl on medication or after medication&#xD;
             withdrawal.&#xD;
&#xD;
          -  Unwillingness or inability to withdraw medication for three weeks prior to, and for&#xD;
             the duration of the study.&#xD;
&#xD;
          -  For female subjects: positive pregnancy test at the time of enrollment or study&#xD;
&#xD;
          -  History of prior upper abdominal surgery such as adjustable gastric banding,&#xD;
             pyloroplasty and vagotomy.&#xD;
&#xD;
          -  Active systemic illness or malignancy.&#xD;
&#xD;
          -  Symptomatic macrovascular or microvascular disease.&#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</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>
  </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>January 2023</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>January 4, 2023</last_update_submitted>
  <last_update_submitted_qc>January 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2023</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>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heparin</mesh_term>
    <mesh_term>Calcium heparin</mesh_term>
    <mesh_term>Soybean oil, phospholipid emulsion</mesh_term>
  </intervention_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/NCT04466618
org study id: 20-003993
nct id: NCT04466618
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
GLP-1 is a hormone made by the body that promotes the production of insulin in response to
      eating. However, there is increasing evidence that this hormone might help support the body's
      ability to produce insulin when diabetes develops. The purpose of this study is to determine
      the effect of endogenous GLP-1 secretion on insulin secretion in people with and without type
      2 diabetes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Glucagon Concentrations
time frame: Average concentration over the 0-180minutes of study
description: Measured by immunoassay
arm group label: Saline
arm group type: Placebo Comparator
description: Saline infusion
arm group label: Exendin-9,39
arm group type: Active Comparator
description: Exendin-9,39 infusion
arm group label: Saline + Intralipid/Heparin
arm group type: Active Comparator
description: Induction of acute insulin resistance during Saline infusion
arm group label: Exendin-9,39 + Intralipid/Heparin
arm group type: Active Comparator
description: Induction of acute insulin resistance during Exendin-9,39 infusion
intervention type: Biological
intervention name: Saline
description: Saline infused during the study
arm group label: Saline
intervention type: Biological
intervention name: Exendin-9,39
description: Exendin-9,39 infused during the study
arm group label: Exendin-9,39
intervention type: Biological
intervention name: Saline + Intralipid/Heparin
description: Saline infused during acute insulin resistance
arm group label: Saline + Intralipid/Heparin
intervention type: Biological
intervention name: Exendin-9,39 + Intralipid/Heparin
description: Exendin-9,39 infused during acute insulin resistance
arm group label: Exendin-9,39 + Intralipid/Heparin
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Adrian Vella
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
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: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Heparin
mesh term: Calcium heparin
mesh term: Soybean oil, phospholipid emulsion
sharing ipd: No