<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/NCT01694004</url>
  </required_header>
  <id_info>
    <org_study_id>IRB #121111</org_study_id>
    <secondary_id>P30DK058404</secondary_id>
    <nct_id>NCT01694004</nct_id>
  </id_info>
  <brief_title>Nutrient Sensing in the Duodenum</brief_title>
  <official_title>Duodenal Lipid Sensing and Nutrient Absorption</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</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>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>
      Preliminary studies in humans suggest that the presence of lipids in the gut can modify&#xD;
      glucose absorption. The overall hypothesis of this proposal is that long chain fatty acid&#xD;
      sensing in the duodenum has a significant role in modifying nutrient (glucose and amino acid)&#xD;
      absorption from the GI tract through a gut-brain-gut axis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigator will conduct a study in 20 lean (BMI = 19-27 kg/m2) subjects involving&#xD;
      intravenous (IV) and intraduodenal (ID) infusions of glucose tracers or amino acid tracers&#xD;
      and measurement of tracer rate of appearance in the plasma. An ID infusion of LCFA will allow&#xD;
      the investigators to determine if LCFA can alter nutrient absorption and glucose and amino&#xD;
      acid metabolism. Benzocaine will be added to the ID infusion of LCFA to inhibit nerve&#xD;
      terminals in the duodenum thereby preventing gut-brain communication. Plasma levels of&#xD;
      glucose and amino acid tracers, glucose oxidation (13CO2 breath test), gut hormones (CCK,&#xD;
      GIP, PYY, GLP-1, ghrelin), and bioactive lipids (N-acyl phosphatidylethanolamines, NAPEs)&#xD;
      will be measured during all infusion periods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nutrient Absorption</measure>
    <time_frame>6 hours</time_frame>
    <description>Stable isotope tracers (glucose or amino acid) will be administered intravenously (IV) and intraduodenally (ID) and tracer rate of appearance in the plasma will be measured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Substrate Oxidation</measure>
    <time_frame>6 hours</time_frame>
    <description>Oxidation of intraduodenally administered glucose or amino acid will be determined by the amount of 13C recovered from expired air.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut Hormone Levels</measure>
    <time_frame>6 hours</time_frame>
    <description>Plasma levels of gut hormones will be measured by standard RIA or ELISA assays</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Bioactive Lipids</measure>
    <time_frame>6 hours</time_frame>
    <description>Plasma levels of N-acyl phosphatidylethanolamines (NAPES)will be measured by LC-MS</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>The Effect of LCFA on Nutrient Absorption</condition>
  <arm_group>
    <arm_group_label>Benzocaine Infusion into Duodenum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The investigator will conduct a study in 20 lean (BMI = 19-27 kg/m2) subjects involving intravenous (IV) and intraduodenal (ID) infusions of glucose tracers or amino acid traces and measurement of tracer rate of appearance in the plasma. An ID infusion of LCFA will allow the investigators to determine if LCFA can alter nutrient absorption and glucose and amino acid metabolism. Benzocaine will be added to the ID infusion of LCFA to inhibit nerve terminals in the duodenum thereby preventing gut-brain communication. Plasma levels of glucose and amino acid tracers, glucose oxidation (13CO2 breath test), gut hormones (CCK, GIP, PYY, GLP-1, ghrelin), and bioactive lipids (N-acyl phosphatidylethanolamines, NAPEs) will be measured during all infusion periods.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Benzocaine Infusion into Duodenum</intervention_name>
    <arm_group_label>Benzocaine Infusion into Duodenum</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI = 19-27 kg/m2&#xD;
&#xD;
          -  30-55 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication for nasal tube placement (e.g. deviated septum, prior upper&#xD;
             gastrointestinal bleed, or history of easy bleeding)&#xD;
&#xD;
          -  Prior gastric or intestinal surgery or pancreas resection&#xD;
&#xD;
          -  Females with a positive pregnancy test&#xD;
&#xD;
          -  Known history of intestinal diseases including (but not limited to) inflammatory bowel&#xD;
             disease (e.g. ulcerative colitis, Crohn's disease), celiac sprue, Barrett's esophagus&#xD;
&#xD;
          -  Type 1 or type 2 diabetes&#xD;
&#xD;
          -  Gastroenteritis (diarrhea and/or vomiting) or constipation within the past week&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robyn Tamboli, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Naji Abumrad, MD</last_name>
    <role>Study Director</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>January 26, 2023</last_update_submitted>
  <last_update_submitted_qc>January 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Robyn Tamboli</investigator_full_name>
    <investigator_title>Research Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Nutrient absorption</keyword>
  <keyword>Duodenal feeding tube</keyword>
  <keyword>Gut-brain-gut axis</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Benzocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT01694004
org study id: IRB #121111
secondary id: P30DK058404
nct id: NCT01694004
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Preliminary studies in humans suggest that the presence of lipids in the gut can modify
      glucose absorption. The overall hypothesis of this proposal is that long chain fatty acid
      sensing in the duodenum has a significant role in modifying nutrient (glucose and amino acid)
      absorption from the GI tract through a gut-brain-gut axis.
The investigator will conduct a study in 20 lean (BMI = 19-27 kg/m2) subjects involving
      intravenous (IV) and intraduodenal (ID) infusions of glucose tracers or amino acid tracers
      and measurement of tracer rate of appearance in the plasma. An ID infusion of LCFA will allow
      the investigators to determine if LCFA can alter nutrient absorption and glucose and amino
      acid metabolism. Benzocaine will be added to the ID infusion of LCFA to inhibit nerve
      terminals in the duodenum thereby preventing gut-brain communication. Plasma levels of
      glucose and amino acid tracers, glucose oxidation (13CO2 breath test), gut hormones (CCK,
      GIP, PYY, GLP-1, ghrelin), and bioactive lipids (N-acyl phosphatidylethanolamines, NAPEs)
      will be measured during all infusion periods.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Nutrient Absorption
time frame: 6 hours
description: Stable isotope tracers (glucose or amino acid) will be administered intravenously (IV) and intraduodenally (ID) and tracer rate of appearance in the plasma will be measured.
measure: Substrate Oxidation
time frame: 6 hours
description: Oxidation of intraduodenally administered glucose or amino acid will be determined by the amount of 13C recovered from expired air.
measure: Gut Hormone Levels
time frame: 6 hours
description: Plasma levels of gut hormones will be measured by standard RIA or ELISA assays
measure: Bioactive Lipids
time frame: 6 hours
description: Plasma levels of N-acyl phosphatidylethanolamines (NAPES)will be measured by LC-MS
arm group label: Benzocaine Infusion into Duodenum
arm group type: Experimental
description: The investigator will conduct a study in 20 lean (BMI = 19-27 kg/m2) subjects involving intravenous (IV) and intraduodenal (ID) infusions of glucose tracers or amino acid traces and measurement of tracer rate of appearance in the plasma. An ID infusion of LCFA will allow the investigators to determine if LCFA can alter nutrient absorption and glucose and amino acid metabolism. Benzocaine will be added to the ID infusion of LCFA to inhibit nerve terminals in the duodenum thereby preventing gut-brain communication. Plasma levels of glucose and amino acid tracers, glucose oxidation (13CO2 breath test), gut hormones (CCK, GIP, PYY, GLP-1, ghrelin), and bioactive lipids (N-acyl phosphatidylethanolamines, NAPEs) will be measured during all infusion periods.
intervention type: Drug
intervention name: Benzocaine Infusion into Duodenum
arm group label: Benzocaine Infusion into Duodenum
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Robyn Tamboli, PhD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
last name: Naji Abumrad, MD
role: Study Director
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Robyn Tamboli
investigator title: Research Assistant Professor
mesh term: Benzocaine
sharing ipd: Undecided