<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/NCT03018444</url>
  </required_header>
  <id_info>
    <org_study_id>H-16034243</org_study_id>
    <nct_id>NCT03018444</nct_id>
  </id_info>
  <brief_title>The Effect of HMG-CoA Reductase Inhibition on Postprandial GLP-1 Secretion</brief_title>
  <official_title>The Effect of HMG-CoA Reductase Inhibition on Postprandial GLP-1 Secretion</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>
  <brief_summary>
    <textblock>
      The primary objective of the present study is to evaluate the effect of HMG-CoA reductase&#xD;
      inhibition during 14 days on the postprandial plasma GLP-1 response in healthy individuals.&#xD;
      Secondary objectives include the evaluation of HMG-CoA reductase inhibition on postprandial&#xD;
      glucose tolerance, gallbladder emptying, gastric emptying, plasma responses of lipids, bile&#xD;
      acids and pancreatic and enteric hormones known to influence glucose metabolism and appetite,&#xD;
      and faecal content of bile acids and gut microbiota composition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postprandial GLP-1 secretion</measure>
    <time_frame>240 min</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postprandial Bile Acid Composition</measure>
    <time_frame>240 min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial total plasma Bile Acid</measure>
    <time_frame>240 min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial Glucose Tolerance</measure>
    <time_frame>240 min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial plasma lipid response</measure>
    <time_frame>240 min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial GIP secretion</measure>
    <time_frame>240 min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Enteric hormones known to influence glucose metabolism</measure>
    <time_frame>240 min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gallbladder emptying</measure>
    <time_frame>240 min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Faecal content of bile acid</measure>
    <time_frame>One sample collected on day 12 or 13 of the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut microbiota composition</measure>
    <time_frame>One sample collected on day 12 or 13 of the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastric emptying</measure>
    <time_frame>240 min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting Energy Expenditure</measure>
    <time_frame>At time -20 min, +60 min and +220 min</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Hydroxymethylglutaryl-CoA Reductase Inhibitors</condition>
  <arm_group>
    <arm_group_label>Atorvastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 weeks treatment with Atorvastatin (1st week 40 mg once daily on day, 2nd week 80 mg (2x40mg) once daily)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 weeks treatment with placebo tablets of comparable sizes and color to the Atorvastatin tablets (1st week one tablet once daily, 2nd week two tablets once daily)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin</intervention_name>
    <description>Atorvastatin tablet</description>
    <arm_group_label>Atorvastatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo tablet</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) &gt;18.5 kg/m2 and &lt;35 kg/m2&#xD;
&#xD;
          -  Caucasian ethnicity&#xD;
&#xD;
          -  Normal haemoglobin&#xD;
&#xD;
          -  Glycated haemoglobin (HbA1c) &lt;43 mmol/mol&#xD;
&#xD;
          -  Fasting plasma glucose &lt;6 mmol/l&#xD;
&#xD;
          -  Informed and written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  First-degree relatives with diabetes (both type 1 diabetes and type 2 diabetes)&#xD;
&#xD;
          -  Liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate&#xD;
             aminotransferase (ASAT) &gt;2 times normal values) or history of hepatobiliary disorder&#xD;
&#xD;
          -  Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major&#xD;
             intra-abdominal surgery&#xD;
&#xD;
          -  Reduced kidney function or nephropathy (estimated glomerular filtration rate (eGFR)&#xD;
             &lt;60 ml/min/1.73 m2 (based on serum creatinine) and/or albuminuria&#xD;
&#xD;
          -  Taking any kind of medicine on a regular basis&#xD;
&#xD;
          -  Intake of antibiotics two months prior to study&#xD;
&#xD;
          -  Active or recent malignant disease&#xD;
&#xD;
          -  Any treatment or condition requiring acute or sub-acute medical or surgical&#xD;
             intervention&#xD;
&#xD;
          -  Any condition considered incompatible with participation by the investigators&#xD;
&#xD;
          -  If the subjects receive any antibiotic treatment while included in the study they will&#xD;
             be excluded&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Filip K. Knop, Professor MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Clinical Medicine, University of Copenhagen, Gentofte Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital, Gentofte, Copenhagen</name>
      <address>
        <city>Hellerup</city>
        <state>Region Hovedstaden</state>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>March 2, 2017</last_update_submitted>
  <last_update_submitted_qc>March 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Gentofte, Copenhagen</investigator_affiliation>
    <investigator_full_name>Filip Krag Knop</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atorvastatin</mesh_term>
  </intervention_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/NCT03018444
org study id: H-16034243
nct id: NCT03018444
lead sponsor: 
The primary objective of the present study is to evaluate the effect of HMG-CoA reductase
      inhibition during 14 days on the postprandial plasma GLP-1 response in healthy individuals.
      Secondary objectives include the evaluation of HMG-CoA reductase inhibition on postprandial
      glucose tolerance, gallbladder emptying, gastric emptying, plasma responses of lipids, bile
      acids and pancreatic and enteric hormones known to influence glucose metabolism and appetite,
      and faecal content of bile acids and gut microbiota composition.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Investigator)
measure: Postprandial GLP-1 secretion
time frame: 240 min
measure: Postprandial Bile Acid Composition
time frame: 240 min
measure: Postprandial total plasma Bile Acid
time frame: 240 min
measure: Postprandial Glucose Tolerance
time frame: 240 min
measure: Postprandial plasma lipid response
time frame: 240 min
measure: Postprandial GIP secretion
time frame: 240 min
measure: Enteric hormones known to influence glucose metabolism
time frame: 240 min
measure: Gallbladder emptying
time frame: 240 min
measure: Faecal content of bile acid
time frame: One sample collected on day 12 or 13 of the intervention
measure: Gut microbiota composition
time frame: One sample collected on day 12 or 13 of the intervention
measure: Gastric emptying
time frame: 240 min
measure: Resting Energy Expenditure
time frame: At time -20 min, +60 min and +220 min
arm group label: Atorvastatin
arm group type: Experimental
description: 2 weeks treatment with Atorvastatin (1st week 40 mg once daily on day, 2nd week 80 mg (2x40mg) once daily)
arm group label: Placebo
arm group type: Placebo Comparator
description: 2 weeks treatment with placebo tablets of comparable sizes and color to the Atorvastatin tablets (1st week one tablet once daily, 2nd week two tablets once daily)
intervention type: Drug
intervention name: Atorvastatin
description: Atorvastatin tablet
arm group label: Atorvastatin
intervention type: Other
intervention name: Placebo
description: Placebo tablet
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Filip K. Knop, Professor MD
role: Principal Investigator
affiliation: Department of Clinical Medicine, University of Copenhagen, Gentofte Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Gentofte, Copenhagen
investigator full name: Filip Krag Knop
investigator title: Professor
mesh term: Diabetes Mellitus, Type 2
mesh term: Atorvastatin