<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/NCT03783052</url>
  </required_header>
  <id_info>
    <org_study_id>S60930</org_study_id>
    <nct_id>NCT03783052</nct_id>
  </id_info>
  <brief_title>Gastrointestinal Physiological Conditions in Obesity and After Bariatric Surgery</brief_title>
  <acronym>GASTON</acronym>
  <official_title>Gastrointestinal Physiological Conditions in Obesity and After Bariatric Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Over the years, obesity has become a major public health concern. The increasing rates of&#xD;
      obesity are associated with an enhanced demand for weight-loss with bariatric surgery as a&#xD;
      treatment option. Bariatric surgery procedures alter the anatomical structure of the&#xD;
      gastrointestinal tract, which contributes to the postoperative weight loss. However, it is&#xD;
      not sure how obesity and the anatomical alterations of bariatric surgery affect the&#xD;
      gastrointestinal physiology including gastrointestinal pH, gastric emptying, intestinal&#xD;
      transit time and concentration of enzymes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the visit in the obesity clinic, eligible patients will be approached for&#xD;
      participation by the sub-investigator. Interested patients will receive information regarding&#xD;
      the study and receive the information sheet containing the informed consent form. After&#xD;
      signing the informed consent form, volunteers will be invited to come to the clinical&#xD;
      research center:&#xD;
&#xD;
        -  Healthy volunteers: Gastrointestinal physiology will be analyzed during two visits using&#xD;
           a telemetric capsule. During the first visit, the physiological conditions of interest&#xD;
           will be analysed in fasted state using the telemetric capsule. During the second visit,&#xD;
           the physiological conditions of interest will be analysed in fed state using the&#xD;
           telemetric capsule.&#xD;
&#xD;
        -  Obese volunteers: Gastrointestinal physiology will be analyzed during two visits using a&#xD;
           telemetric capsule. During the first visit, the physiological conditions of interest&#xD;
           will be analysed in fasted state using the telemetric capsule. During the second visit,&#xD;
           the physiological conditions of interest will be analysed in fed state using the&#xD;
           telemetric capsule.&#xD;
&#xD;
        -  Obese volunteers: Gastrointestinal physiology will be analyzed during three visits using&#xD;
           a telemetric capsule, scintigraphy and via the collection of gastrointestinal samples.&#xD;
           During the first visit, the physiological conditions of interest will be analysed in&#xD;
           fasted state using the telemetric capsule. During the second visit, gastrointestinal&#xD;
           samples will be collected at the level of the stomach, the duodenum and jejunum via&#xD;
           aspiration through multiple lumen catheters in fasted and fed state. During the third&#xD;
           visit, gastric emptying will be observed via scintigraphy in fed state.&#xD;
&#xD;
        -  Volunteers after Sleeve Gastrectomy: Gastrointestinal physiology will be analyzed during&#xD;
           three visits using a telemetric capsule, scintigraphy and via the collection of&#xD;
           gastrointestinal samples. During the first visit, the physiological conditions of&#xD;
           interest will be analysed in fasted state using the telemetric capsule. During the&#xD;
           second visit, gastrointestinal samples will be collected at the level of the sleeve, the&#xD;
           duodenum and jejunum via aspiration through multiple lumen catheters in fasted and fed&#xD;
           state. During the third visit, gastric emptying will be observed via scintigraphy in fed&#xD;
           state.&#xD;
&#xD;
        -  Volunteers after Roux-en-Y gastric Bypass: Gastrointestinal physiology will be analyzed&#xD;
           during three visits using a telemetric capsule, scintigraphy and via the collection of&#xD;
           gastrointestinal samples. During the first visit, the physiological conditions of&#xD;
           interest will be analysed in fasted state using the telemetric capsule. During the&#xD;
           second visit, gastrointestinal samples will be collected at the level of the pouch, the&#xD;
           Roux limb and the common limb via aspiration through multiple lumen catheters in fasted&#xD;
           and fed state. During the third visit, gastric emptying will be observed via&#xD;
           scintigraphy in fed state.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">March 30, 2021</completion_date>
  <primary_completion_date type="Actual">March 30, 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gastrointestinal Temperature</measure>
    <time_frame>0-7 days</time_frame>
    <description>Gastrointestinal Temperature (°C)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gastrointestinal pH</measure>
    <time_frame>0-7 days</time_frame>
    <description>Gastrointestinal pH (pH values)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gastrointestinal Pressure</measure>
    <time_frame>0-7 days</time_frame>
    <description>Gastrointestinal Pressure (mmHg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of bile acids</measure>
    <time_frame>1 day</time_frame>
    <description>Concentration of bile acids</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gastric emptying time</measure>
    <time_frame>2 hours</time_frame>
    <description>Gastric emptying time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal motility</measure>
    <time_frame>0-7 days</time_frame>
    <description>Contractions per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal transit times</measure>
    <time_frame>0-7 days</time_frame>
    <description>Gastric Emptying Time (hours), Small Bowel Transit Time (hours), Colonic Transit Time (hours) and Whole Gut Transit Time (hours)</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Obesity</condition>
  <condition>Bariatric Surgery Candidate</condition>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>11 Healthy volunteers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese volunteers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>11 Obese Volunteers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Roux-en-Y Gastric Bypass patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>6 volunteers with a Roux-en-Y Gastric Bypass</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleeve Gastrectomy patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>6 volunteers with a Sleeve Gastrectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Volunteers with obesity</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>6 obese volunteers</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SmartPill in fasted state</intervention_name>
    <description>SmartPill administration in fasted state</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Obese volunteers</arm_group_label>
    <arm_group_label>Roux-en-Y Gastric Bypass patients</arm_group_label>
    <arm_group_label>Sleeve Gastrectomy patients</arm_group_label>
    <arm_group_label>Volunteers with obesity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SmartPill in fed state</intervention_name>
    <description>SmartPill administration in fed state</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Obese volunteers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aspiration</intervention_name>
    <description>Aspiration of gastrointestinal samples in fasted and fed state</description>
    <arm_group_label>Roux-en-Y Gastric Bypass patients</arm_group_label>
    <arm_group_label>Sleeve Gastrectomy patients</arm_group_label>
    <arm_group_label>Volunteers with obesity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gastric emptying scintigraphy</intervention_name>
    <description>Gastric emptying scintigraphy in fed state</description>
    <arm_group_label>Roux-en-Y Gastric Bypass patients</arm_group_label>
    <arm_group_label>Sleeve Gastrectomy patients</arm_group_label>
    <arm_group_label>Volunteers with obesity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - 18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of gastric ulcers&#xD;
&#xD;
          -  Disorders of swallowing&#xD;
&#xD;
          -  Suspected strictures, fistulas or physiological GI obstruction.&#xD;
&#xD;
          -  GI surgery within past three months&#xD;
&#xD;
          -  Severe dysphagia to food or pills&#xD;
&#xD;
          -  Crohns disease or diverticulitis&#xD;
&#xD;
          -  Use of implanted or portable electro-mechanical medical devices&#xD;
&#xD;
          -  Known intolerance to the SmartPill device&#xD;
&#xD;
          -  Known food allergies to any component of the meal&#xD;
&#xD;
          -  History of multiple bariatric surgeries&#xD;
&#xD;
          -  Pregnant or lactating women&#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>
  <overall_official>
    <last_name>Bart Van der Schueren, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven, Department of Endocrinology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>October 18, 2022</last_update_submitted>
  <last_update_submitted_qc>October 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT03783052
org study id: S60930
nct id: NCT03783052
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Over the years, obesity has become a major public health concern. The increasing rates of
      obesity are associated with an enhanced demand for weight-loss with bariatric surgery as a
      treatment option. Bariatric surgery procedures alter the anatomical structure of the
      gastrointestinal tract, which contributes to the postoperative weight loss. However, it is
      not sure how obesity and the anatomical alterations of bariatric surgery affect the
      gastrointestinal physiology including gastrointestinal pH, gastric emptying, intestinal
      transit time and concentration of enzymes.
During the visit in the obesity clinic, eligible patients will be approached for
      participation by the sub-investigator. Interested patients will receive information regarding
      the study and receive the information sheet containing the informed consent form. After
      signing the informed consent form, volunteers will be invited to come to the clinical
      research center:

        -  Healthy volunteers: Gastrointestinal physiology will be analyzed during two visits using
           a telemetric capsule. During the first visit, the physiological conditions of interest
           will be analysed in fasted state using the telemetric capsule. During the second visit,
           the physiological conditions of interest will be analysed in fed state using the
           telemetric capsule.

        -  Obese volunteers: Gastrointestinal physiology will be analyzed during two visits using a
           telemetric capsule. During the first visit, the physiological conditions of interest
           will be analysed in fasted state using the telemetric capsule. During the second visit,
           the physiological conditions of interest will be analysed in fed state using the
           telemetric capsule.

        -  Obese volunteers: Gastrointestinal physiology will be analyzed during three visits using
           a telemetric capsule, scintigraphy and via the collection of gastrointestinal samples.
           During the first visit, the physiological conditions of interest will be analysed in
           fasted state using the telemetric capsule. During the second visit, gastrointestinal
           samples will be collected at the level of the stomach, the duodenum and jejunum via
           aspiration through multiple lumen catheters in fasted and fed state. During the third
           visit, gastric emptying will be observed via scintigraphy in fed state.

        -  Volunteers after Sleeve Gastrectomy: Gastrointestinal physiology will be analyzed during
           three visits using a telemetric capsule, scintigraphy and via the collection of
           gastrointestinal samples. During the first visit, the physiological conditions of
           interest will be analysed in fasted state using the telemetric capsule. During the
           second visit, gastrointestinal samples will be collected at the level of the sleeve, the
           duodenum and jejunum via aspiration through multiple lumen catheters in fasted and fed
           state. During the third visit, gastric emptying will be observed via scintigraphy in fed
           state.

        -  Volunteers after Roux-en-Y gastric Bypass: Gastrointestinal physiology will be analyzed
           during three visits using a telemetric capsule, scintigraphy and via the collection of
           gastrointestinal samples. During the first visit, the physiological conditions of
           interest will be analysed in fasted state using the telemetric capsule. During the
           second visit, gastrointestinal samples will be collected at the level of the pouch, the
           Roux limb and the common limb via aspiration through multiple lumen catheters in fasted
           and fed state. During the third visit, gastric emptying will be observed via
           scintigraphy in fed state.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Gastrointestinal Temperature
time frame: 0-7 days
description: Gastrointestinal Temperature (°C)
measure: Gastrointestinal pH
time frame: 0-7 days
description: Gastrointestinal pH (pH values)
measure: Gastrointestinal Pressure
time frame: 0-7 days
description: Gastrointestinal Pressure (mmHg)
measure: Concentration of bile acids
time frame: 1 day
description: Concentration of bile acids
measure: Gastric emptying time
time frame: 2 hours
description: Gastric emptying time
measure: Gastrointestinal motility
time frame: 0-7 days
description: Contractions per minute
measure: Gastrointestinal transit times
time frame: 0-7 days
description: Gastric Emptying Time (hours), Small Bowel Transit Time (hours), Colonic Transit Time (hours) and Whole Gut Transit Time (hours)
arm group label: Healthy volunteers
arm group type: Other
description: 11 Healthy volunteers
arm group label: Obese volunteers
arm group type: Other
description: 11 Obese Volunteers
arm group label: Roux-en-Y Gastric Bypass patients
arm group type: Other
description: 6 volunteers with a Roux-en-Y Gastric Bypass
arm group label: Sleeve Gastrectomy patients
arm group type: Other
description: 6 volunteers with a Sleeve Gastrectomy
arm group label: Volunteers with obesity
arm group type: Other
description: 6 obese volunteers
intervention type: Device
intervention name: SmartPill in fasted state
description: SmartPill administration in fasted state
arm group label: Healthy volunteers
arm group label: Obese volunteers
arm group label: Roux-en-Y Gastric Bypass patients
arm group label: Sleeve Gastrectomy patients
arm group label: Volunteers with obesity
intervention type: Device
intervention name: SmartPill in fed state
description: SmartPill administration in fed state
arm group label: Healthy volunteers
arm group label: Obese volunteers
intervention type: Other
intervention name: Aspiration
description: Aspiration of gastrointestinal samples in fasted and fed state
arm group label: Roux-en-Y Gastric Bypass patients
arm group label: Sleeve Gastrectomy patients
arm group label: Volunteers with obesity
intervention type: Other
intervention name: Gastric emptying scintigraphy
description: Gastric emptying scintigraphy in fed state
arm group label: Roux-en-Y Gastric Bypass patients
arm group label: Sleeve Gastrectomy patients
arm group label: Volunteers with obesity
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bart Van der Schueren, PhD
role: Principal Investigator
affiliation: UZ Leuven, Department of Endocrinology
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Obesity
sharing ipd: No