<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/NCT03228602</url>
  </required_header>
  <id_info>
    <org_study_id>JACQUIN PEGASE 2016</org_study_id>
    <nct_id>NCT03228602</nct_id>
  </id_info>
  <brief_title>Impaired Gustatory Sensory Perception in Obese and Obese Diabetic Persons</brief_title>
  <acronym>PEGASE</acronym>
  <official_title>Gustatory Evoked Potentials and Cerebral Control of Food Intake in Obese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</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>
      The aim of the study is to compare several parameters in three distinct groups of subjects:&#xD;
      persons with obesity, persons with obesity and diabetes and persons with neither obesity nor&#xD;
      diabetes:&#xD;
&#xD;
        -  the electrical activity in response to a sweet solution, measured before and after a&#xD;
           standard meal, using gustatory evoked potentials (recording explained below)&#xD;
&#xD;
        -  blood hormone levels related to weight gain (insulin, dopamine, ghrelin, leptin:&#xD;
           measured in blood samples)&#xD;
&#xD;
        -  levels of activity and quantity of an enzyme present in the saliva, amylase, which is&#xD;
           able to break down ingested starch into several molecules of glucose.&#xD;
&#xD;
      All of these parameters will be correlated to determine whether the results are different in&#xD;
      the 3 groups of subjects in the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    lack of inclusion&#xD;
  </why_stopped>
  <start_date type="Actual">July 11, 2016</start_date>
  <completion_date type="Actual">May 12, 2021</completion_date>
  <primary_completion_date type="Actual">January 21, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amplitude of the gustatory evoked potential</measure>
    <time_frame>Up to 10 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Latency of the gustatory evoked potential</measure>
    <time_frame>Up to 10 days</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Obesity</condition>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>healthy subjects</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>obese</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>obese diabetic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>obese diabetic who are going to be operated on</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 of a sleeve gastrectomy and 25 of a Y gastric bypass</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Recording of GEP (Gustatory Evoked Potentials)</intervention_name>
    <description>record cerebral activity thanks to electrodes placed on the head and fixed with a painless, harmless adhesive paste and linked to a computer equipped with specific software to interpret the signals obtained. The collection of data for the electric signal takes 20 minutes.</description>
    <arm_group_label>healthy subjects</arm_group_label>
    <arm_group_label>obese</arm_group_label>
    <arm_group_label>obese diabetic</arm_group_label>
    <arm_group_label>obese diabetic who are going to be operated on</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have provided written consent&#xD;
&#xD;
          -  Patients over 18 years old&#xD;
&#xD;
          -  Body Mass Index (BMI) &lt;25 kg/m² for healthy volunteers and BMI≥30 kg/m² for obese&#xD;
             subjects&#xD;
&#xD;
          -  Patients with type 2 diabetes for the group &quot;obese diabetic subjects&quot;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under guardianship&#xD;
&#xD;
          -  Patients without health insurance cover&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Active smokers&#xD;
&#xD;
          -  Subjects with type 2 diabetes for the &quot; healthy subjects &quot; and &quot; obese subjects &quot;,&#xD;
             subjects with type 1 diabetes for all groups&#xD;
&#xD;
          -  Subjects who do not speak French&#xD;
&#xD;
          -  Treatment that interferes with taste or acts on the central nervous system&#xD;
&#xD;
          -  Anti-diabetic treatment with GLP-1 analogues (Glucagon-like peptide 1) or SGLT2&#xD;
             (sodium-glucose cotransporter type 2)&#xD;
&#xD;
          -  Known hypersensitivity to the foods proposed in the study, or the paste used to fix&#xD;
             the electrodes, or to paraffin wax or to the products tested (sucrose, glucose or&#xD;
             starch for the gustatory evoked potentials and triangular tests)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>June 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>June 8, 2022</last_update_submitted>
  <last_update_submitted_qc>June 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03228602
org study id: JACQUIN PEGASE 2016
nct id: NCT03228602
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to compare several parameters in three distinct groups of subjects:
      persons with obesity, persons with obesity and diabetes and persons with neither obesity nor
      diabetes:

        -  the electrical activity in response to a sweet solution, measured before and after a
           standard meal, using gustatory evoked potentials (recording explained below)

        -  blood hormone levels related to weight gain (insulin, dopamine, ghrelin, leptin:
           measured in blood samples)

        -  levels of activity and quantity of an enzyme present in the saliva, amylase, which is
           able to break down ingested starch into several molecules of glucose.

      All of these parameters will be correlated to determine whether the results are different in
      the 3 groups of subjects in the study.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Amplitude of the gustatory evoked potential
time frame: Up to 10 days
measure: Latency of the gustatory evoked potential
time frame: Up to 10 days
arm group label: healthy subjects
arm group type: Active Comparator
arm group label: obese
arm group type: Experimental
arm group label: obese diabetic
arm group type: Experimental
arm group label: obese diabetic who are going to be operated on
arm group type: Experimental
description: 25 of a sleeve gastrectomy and 25 of a Y gastric bypass
intervention type: Other
intervention name: Recording of GEP (Gustatory Evoked Potentials)
description: record cerebral activity thanks to electrodes placed on the head and fixed with a painless, harmless adhesive paste and linked to a computer equipped with specific software to interpret the signals obtained. The collection of data for the electric signal takes 20 minutes.
arm group label: healthy subjects
arm group label: obese
arm group label: obese diabetic
arm group label: obese diabetic who are going to be operated on
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor