<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/NCT03305783</url>
  </required_header>
  <id_info>
    <org_study_id>H-15016324</org_study_id>
    <nct_id>NCT03305783</nct_id>
  </id_info>
  <brief_title>The Influence of Cholecystectomy on Secretion of Incretin Hormones</brief_title>
  <official_title>The Influence of Cholecystectomy on Secretion of Incretin Hormones</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Gentofte, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Gentofte, Copenhagen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The effect of cholecystectomy on postprandial plasma GLP-1 responses (primary endpoint) and&#xD;
      glucose metabolism will be evaluated in 30 patients planned to undergo elective laparoscopic&#xD;
      cholecystectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational, parallel-group study in 30 patients with gallstone disease and 10&#xD;
      healthy control subjects. In patients undergoing cholecystectomy a 4h-meal test (liquid mixed&#xD;
      meal) will be conducted at baseline (1-2 weeks before surgery) and again within 4 weeks after&#xD;
      the cholecystectomy. Healthy subjects will be submitted to a single 4h-meal test.&#xD;
&#xD;
      Secondary endpoints include changes in plasma glucose, insulin, glucagon, GIP, PYY, gastrin,&#xD;
      CCK, fibroblast growth factor 19 (FGF-19) and bile acids. Furthermore, secondary endpoints&#xD;
      include changes in gastric emptying (evaluated by the paracetamol method).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">April 1, 2022</completion_date>
  <primary_completion_date type="Actual">March 11, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Postprandial GLP-1 response</measure>
    <time_frame>240 min</time_frame>
    <description>Gut derived hormone secretion after a 4 h meal test measured in pmol/liter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>plasma glucose</measure>
    <time_frame>240 min</time_frame>
    <description>measured in mmol/liter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gastric emptying</measure>
    <time_frame>240 min</time_frame>
    <description>evaluated by the paracetamol method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting metabolic rate</measure>
    <time_frame>240 min</time_frame>
    <description>evaluated by calorimetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>insulin</measure>
    <time_frame>240 min</time_frame>
    <description>measured in pmol/liter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucagon</measure>
    <time_frame>240 min</time_frame>
    <description>measured in pmol/liter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PYY</measure>
    <time_frame>240 min</time_frame>
    <description>peptide YY, measured in pmol/liter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GIP</measure>
    <time_frame>240 min</time_frame>
    <description>measured in pmol/liter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CCK</measure>
    <time_frame>240 min</time_frame>
    <description>Cholecystokinin, measured in pmol/liter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FGF-19</measure>
    <time_frame>240 min</time_frame>
    <description>Fibroblast growth factor 19, measured in ng/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrin</measure>
    <time_frame>240 min</time_frame>
    <description>measured in pmol/liter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bile acids</measure>
    <time_frame>240 min</time_frame>
    <description>measured in nmol/ml</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Glucose Metabolism Disorders</condition>
  <arm_group>
    <arm_group_label>Patients having cholecystectomy</arm_group_label>
    <description>Healthy, normal weight patients (BMI&lt;27) undergoing elective cholecystectomy will have a meal test performed before and after surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
    <description>Healthy matched controls will have one meal test performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cholecystectomy</intervention_name>
    <description>elective cholecystectomy performed due to gallstones, cholecystitis or other non-malignant conditions and therefore done regardless of the protocol of this study.</description>
    <arm_group_label>Patients having cholecystectomy</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      biopsies from the gallbladder and ductus cysticus after cholecystectomy biopsies only&#xD;
      collected from 12 subjects.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        A healthy, normal weight population undergoing elective surgery because of gall stone&#xD;
        disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  caucasians above 18 years of age, having an elective cholecystectomy performed because&#xD;
             of gallstone disease.&#xD;
&#xD;
          -  normal fasting plasma glucose and HbA1c&#xD;
&#xD;
          -  normal hgb&#xD;
&#xD;
          -  Normal gallbladder ejection fraction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  liver disease&#xD;
&#xD;
          -  kidney disease&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  ongoing infection&#xD;
&#xD;
          -  abdominal pain not related to gall stones&#xD;
&#xD;
          -  BMI &lt;18,5 kg/m2 eller BMI &gt;30 kg/m2&#xD;
&#xD;
          -  prior abdominal surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Filip K Knop, MD. Proff.</last_name>
    <role>Study Director</role>
    <affiliation>Center for Clinical Metabolic Research, Gentofte hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Clinical Metabolic Research</name>
      <address>
        <city>Copenhagen</city>
        <state>Hellerup</state>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Gentofte, Copenhagen</investigator_affiliation>
    <investigator_full_name>Henriette Holst Nerild</investigator_full_name>
    <investigator_title>MD, Ph.D. student</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>
  <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/NCT03305783
org study id: H-15016324
nct id: NCT03305783
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The effect of cholecystectomy on postprandial plasma GLP-1 responses (primary endpoint) and
      glucose metabolism will be evaluated in 30 patients planned to undergo elective laparoscopic
      cholecystectomy.
This is an observational, parallel-group study in 30 patients with gallstone disease and 10
      healthy control subjects. In patients undergoing cholecystectomy a 4h-meal test (liquid mixed
      meal) will be conducted at baseline (1-2 weeks before surgery) and again within 4 weeks after
      the cholecystectomy. Healthy subjects will be submitted to a single 4h-meal test.

      Secondary endpoints include changes in plasma glucose, insulin, glucagon, GIP, PYY, gastrin,
      CCK, fibroblast growth factor 19 (FGF-19) and bile acids. Furthermore, secondary endpoints
      include changes in gastric emptying (evaluated by the paracetamol method).
observational model: Case-Control
time perspective: Prospective
measure: Postprandial GLP-1 response
time frame: 240 min
description: Gut derived hormone secretion after a 4 h meal test measured in pmol/liter
measure: plasma glucose
time frame: 240 min
description: measured in mmol/liter
measure: gastric emptying
time frame: 240 min
description: evaluated by the paracetamol method
measure: Resting metabolic rate
time frame: 240 min
description: evaluated by calorimetry
measure: insulin
time frame: 240 min
description: measured in pmol/liter
measure: Glucagon
time frame: 240 min
description: measured in pmol/liter
measure: PYY
time frame: 240 min
description: peptide YY, measured in pmol/liter
measure: GIP
time frame: 240 min
description: measured in pmol/liter
measure: CCK
time frame: 240 min
description: Cholecystokinin, measured in pmol/liter
measure: FGF-19
time frame: 240 min
description: Fibroblast growth factor 19, measured in ng/mL
measure: Gastrin
time frame: 240 min
description: measured in pmol/liter
measure: Bile acids
time frame: 240 min
description: measured in nmol/ml
arm group label: Patients having cholecystectomy
description: Healthy, normal weight patients (BMI<27) undergoing elective cholecystectomy will have a meal test performed before and after surgery.
arm group label: Healthy controls
description: Healthy matched controls will have one meal test performed.
intervention type: Procedure
intervention name: cholecystectomy
description: elective cholecystectomy performed due to gallstones, cholecystitis or other non-malignant conditions and therefore done regardless of the protocol of this study.
arm group label: Patients having cholecystectomy
biopsies from the gallbladder and ductus cysticus after cholecystectomy biopsies only
      collected from 12 subjects.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Filip K Knop, MD. Proff.
role: Study Director
affiliation: Center for Clinical Metabolic Research, Gentofte hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Gentofte, Copenhagen
investigator full name: Henriette Holst Nerild
investigator title: MD, Ph.D. student
mesh term: Metabolic Diseases
mesh term: Glucose Metabolism Disorders
sharing ipd: No