<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/NCT04452786</url>
  </required_header>
  <id_info>
    <org_study_id>H-19012015</org_study_id>
    <nct_id>NCT04452786</nct_id>
  </id_info>
  <brief_title>Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty</brief_title>
  <official_title>Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hvidovre University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hvidovre University Hospital</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 investigators of the study want to investigate the complex interactions between glucose&#xD;
      metabolism, food intake/weight loss, and different appetite regulating hormones after ESG in&#xD;
      comparison with conventional laparoscopic sleeve gastrectomy (LSG).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of participants&#xD;
  </why_stopped>
  <start_date type="Actual">June 5, 2020</start_date>
  <completion_date type="Anticipated">April 2023</completion_date>
  <primary_completion_date type="Anticipated">April 2022</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in ghrelin (pg/ml)</measure>
    <time_frame>240 minutes</time_frame>
    <description>Changes in ghrelin after a solid meal test compared before and after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in gut hormone response before and after sugery (pmol/L)</measure>
    <time_frame>240 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Endoscopic Sleeve Gastroplasty</condition>
  <condition>Laparoscopic Sleeve Gastrectomy</condition>
  <condition>Gut Hormones</condition>
  <condition>Glucose Metabolism Disorders</condition>
  <arm_group>
    <arm_group_label>Endoscopic sleeve gastroplasity operated patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopic sleeve gastrectomy operated patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic sleeve gastroplasty</intervention_name>
    <description>Four-hour solid mixed meal test</description>
    <arm_group_label>Endoscopic sleeve gastroplasity operated patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic sleeve gastrectomy</intervention_name>
    <description>Four-hour solid mixed meal test</description>
    <arm_group_label>Laparoscopic sleeve gastrectomy operated patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Scheduled for endoscopic or laparoscopic sleeve at Hvidovre Hospital&#xD;
&#xD;
          -  HbA1c &lt; 48 mmol/mol before surgery, and no history of diabetes&#xD;
&#xD;
          -  HbA1c &lt; 48 mmol/mol and fasting plasma glucose &lt; 6.1 mmol/l at inclusion&#xD;
&#xD;
          -  BMI&lt;45&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hemoglobin &lt; 6.5 mmol/l at inclusion&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Medication affecting the planned examinations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Endocrinology, Hvidovre University Hospital</name>
      <address>
        <city>Copenhagen</city>
        <state>Hvidovre</state>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>August 31, 2021</last_update_submitted>
  <last_update_submitted_qc>August 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hvidovre University Hospital</investigator_affiliation>
    <investigator_full_name>Nora Elisabeth Hedbäck</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>Metabolic Diseases</mesh_term>
    <mesh_term>Glucose Metabolism Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT04452786
org study id: H-19012015
nct id: NCT04452786
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators of the study want to investigate the complex interactions between glucose
      metabolism, food intake/weight loss, and different appetite regulating hormones after ESG in
      comparison with conventional laparoscopic sleeve gastrectomy (LSG).
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Changes in ghrelin (pg/ml)
time frame: 240 minutes
description: Changes in ghrelin after a solid meal test compared before and after surgery
measure: Changes in gut hormone response before and after sugery (pmol/L)
time frame: 240 minutes
arm group label: Endoscopic sleeve gastroplasity operated patients
arm group type: Other
description: Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery
arm group label: Laparoscopic sleeve gastrectomy operated patients
arm group type: Other
description: Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery
intervention type: Procedure
intervention name: Endoscopic sleeve gastroplasty
description: Four-hour solid mixed meal test
arm group label: Endoscopic sleeve gastroplasity operated patients
intervention type: Procedure
intervention name: Laparoscopic sleeve gastrectomy
description: Four-hour solid mixed meal test
arm group label: Laparoscopic sleeve gastrectomy operated patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Hvidovre University Hospital
investigator full name: Nora Elisabeth Hedbäck
investigator title: Principal Investigator
mesh term: Metabolic Diseases
mesh term: Glucose Metabolism Disorders