<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/NCT01674972</url>
  </required_header>
  <id_info>
    <org_study_id>EKBB 224/02.2</org_study_id>
    <nct_id>NCT01674972</nct_id>
  </id_info>
  <brief_title>Glucose-induced Glucagon-like Peptide 1 (GLP-1) Secretion in NAFLD Patients Compared to Healthy Controls</brief_title>
  <official_title>Glucose-induced Glucagon-like Peptide 1 (GLP-1) Secretion in NAFLD Patients Compared to Healthy Controls</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The incretin effect is impaired in patients with type 2 diabetes mellitus (T2DM), thus GLP-1&#xD;
      receptor agonists are used for the treatment of T2DM. Insulin resistance is a&#xD;
      pathophysiologic hallmark of non-alcoholic fatty liver disease (NAFLD). The incretin effect&#xD;
      in patients with NAFLD has not been studied. The aim of this study is to quantify GLP-1&#xD;
      secretion in response to oral glucose tolerance test (oGTT) in patients with NAFLD compared&#xD;
      to healthy controls. The results of this study will expand the knowledge of the&#xD;
      pathophysiology of NAFLD and serve as a rational for potential future treatment strategies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary endpoint: GLP-1 response to oral glucose Secondary endpoints: glucose and insulin&#xD;
      responses to oral glucose challenge&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</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>Glucagon-like Peptide 1 (GLP-1) secretion in response to oGTT</measure>
    <time_frame>0, 15, 30, 60, 90, 120 min. after glucose administration</time_frame>
    <description>The difference in GLP-1 secretion in response to oGTT as assessed by area under the curve (AUC) and peak plasma concentration (cmax) in patients with NAFLD compared to healthy controls.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insulin secretion and glucose curves in response to oGTT</measure>
    <time_frame>0, 15, 30, 60, 90, 120 min. after glucose administration</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">102</enrollment>
  <condition>Non Alcoholic Fatty Liver Disease</condition>
  <condition>Non Alcoholic Steatohepatitis</condition>
  <arm_group>
    <arm_group_label>NAFLD</arm_group_label>
    <description>Patients with biopsy proven NAFLD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Matched healthy control subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Oral glucose tolerance test</intervention_name>
    <description>Oral intake of 75 g glucose after overnight fast</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>NAFLD</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with biopsy proven NAFLD and NASH will be recruited from the Hepatology Outpatient&#xD;
        Clinic, Division of Gastroenterology and Hepatology, University Hospital Basel.&#xD;
&#xD;
        Healthy control subjects will be matched to NAFLD and NASH patients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Biopsy proven NAFLD or NASH&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  additional concomitants liver disease&#xD;
&#xD;
          -  T2DM&#xD;
&#xD;
          -  alcohol consumption &gt;40g/d for male subjects and &gt;20g/d for female subjects&#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>Christoph Beglinger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Basel, Division of Gastroenterology and Hepatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Basel, Division of Gastroenterology and Hepatology</name>
      <address>
        <city>Basel</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>August 24, 2012</last_update_submitted>
  <last_update_submitted_qc>August 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NAFLD</keyword>
  <keyword>NASH</keyword>
  <keyword>GLP-1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</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/NCT01674972
org study id: EKBB 224/02.2
nct id: NCT01674972
lead sponsor: 
has dmc: No
The incretin effect is impaired in patients with type 2 diabetes mellitus (T2DM), thus GLP-1
      receptor agonists are used for the treatment of T2DM. Insulin resistance is a
      pathophysiologic hallmark of non-alcoholic fatty liver disease (NAFLD). The incretin effect
      in patients with NAFLD has not been studied. The aim of this study is to quantify GLP-1
      secretion in response to oral glucose tolerance test (oGTT) in patients with NAFLD compared
      to healthy controls. The results of this study will expand the knowledge of the
      pathophysiology of NAFLD and serve as a rational for potential future treatment strategies.
Primary endpoint: GLP-1 response to oral glucose Secondary endpoints: glucose and insulin
      responses to oral glucose challenge
observational model: Case-Control
time perspective: Prospective
measure: Glucagon-like Peptide 1 (GLP-1) secretion in response to oGTT
time frame: 0, 15, 30, 60, 90, 120 min. after glucose administration
description: The difference in GLP-1 secretion in response to oGTT as assessed by area under the curve (AUC) and peak plasma concentration (cmax) in patients with NAFLD compared to healthy controls.
measure: Insulin secretion and glucose curves in response to oGTT
time frame: 0, 15, 30, 60, 90, 120 min. after glucose administration
arm group label: NAFLD
description: Patients with biopsy proven NAFLD
arm group label: Control
description: Matched healthy control subjects
intervention type: Other
intervention name: Oral glucose tolerance test
description: Oral intake of 75 g glucose after overnight fast
arm group label: Control
arm group label: NAFLD
Plasma samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Christoph Beglinger, MD
role: Principal Investigator
affiliation: University Hospital Basel, Division of Gastroenterology and Hepatology
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease