<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/NCT01696487</url>
  </required_header>
  <id_info>
    <org_study_id>Fru1.0</org_study_id>
    <nct_id>NCT01696487</nct_id>
  </id_info>
  <brief_title>Impact of Fructose Consumption on Intestinal Permeability in Non-alcoholic Fatty Liver Disease (NAFLD) - a Pilot Study.</brief_title>
  <official_title>Impact of Fructose Consumption on Intestinal Permeability in Non-alcoholic Fatty Liver Disease (NAFLD) - a Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>State Government of Vienna, Austria (Medizinisch-Wissenschaftlicher Fonds des Bürgermeisters der Bundeshauptstadt Wien)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The spectrum of NAFLD as emerging epidemic ranges from steatosis to steatohepatitis (NASH),&#xD;
      cirrhosis and hepatocellular carcinoma (HCC). Disease progression is poorly understood and&#xD;
      treatment options are limited. Fructose overconsumption has been associated with gut&#xD;
      permeability and progression of NAFLD. To unravel the mechanisms of fructose-induced&#xD;
      intestinal changes, volunteers will receive a 4-week fructose challenge prior to assessment&#xD;
      of intestinal permeability/translocation using endomicroscopy, sugar probes, serum markers of&#xD;
      intestinal damage, inflammation, iron/copper homeostasis and histological/molecular analysis&#xD;
      of intestinal biopsies. Findings in volunteers will be compared with liver patients&#xD;
      undergoing study procedures without fructose challenge. Translational in vitro experiments&#xD;
      will explore cellular responses to fructose and endotoxin. This project should provide novel&#xD;
      insights into dietary induced alterations of the gut integrity in progression of NAFLD to&#xD;
      NASH.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2013</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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gaps per 1000 intestinal epithelial cells assessed by confocal laser endomicroscopy</measure>
    <time_frame>Time point 1 (day 1 - all study groups)</time_frame>
    <description>Gaps per 1000 intestinal cells will be assesed during gastroscopy by confocal laser endomicroscopy at time point 1 in all study groups and after the 4 week fructose challange in healthy volunteers only</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gaps per 1000 intestinal epithelial cells assessed by confocal laser endomicroscopy</measure>
    <time_frame>point 2 (week4/day28 - after fructose challange; healthy volunteers only)</time_frame>
    <description>Gaps per 1000 intestinal cells will be assesed during gastroscopy by confocal laser endomicroscopy at time point 1 in all study groups and after the 4 week fructose challange in healthy volunteers only</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Non-alcoholic Fatty Liver Disease</condition>
  <condition>Non-alcoholic Steatohepatitis</condition>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Volunteers will be challenged with oral 150g Fructose per day for 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NAFLD</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients with confirmed fatty liver (imaging positive) will be compared at baseline with other arms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NASH</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients with confirmed non-alcoholic steatohepatitis (biopsy proven) will be compared at baseline with other arms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hepatitis C genotype 1 (HCV-GT1)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients with confirmed hepatitis C genotype 1 will be compared at baseline with other arms and act as different liver disease control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>High oral Fructose challenge (150g per day for 28 days)</intervention_name>
    <arm_group_label>Healthy Volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        1. Healthy men and women from 18 to 85, no disease history, no intake of regular&#xD;
             medication.&#xD;
&#xD;
          2. Patients with confirmed (at least one imaging positive) intrahepatic fat accumulation&#xD;
             (NAFL), male and female&#xD;
&#xD;
          3. Patients with confirmed NASH (biopsy within 6 months prior to study), male and female&#xD;
&#xD;
          4. Diagnosed HCV, genotype 1, male and female&#xD;
&#xD;
        Signed informed consent&#xD;
&#xD;
        General exclusion criteria (for all groups)&#xD;
&#xD;
          1. Pregnancy and lactation&#xD;
&#xD;
          2. Imprisoned persons&#xD;
&#xD;
          3. Inflammatory bowel conditions (celiac disease, Crohn's disease, ulcerative colitis)&#xD;
&#xD;
          4. Prior bariatric surgery&#xD;
&#xD;
          5. Alcoholic steatohepatitis and/or alcohol consumption &gt; 140 gramms per week (or &gt;&#xD;
             30g/day)&#xD;
&#xD;
          6. Other liver diseases (autoimmune, genetic, cholestatic, Wilson disease,&#xD;
             Weber-Christian disease, partial lipodystrophy of the face sparing type,&#xD;
             abetalipoproteinemia, and jejunal diverticulosis with bacterial overgrowth.)&#xD;
&#xD;
          7. Virus hepatitis (A, B, C) (except for group (4): defined as HCV, genotype 1)&#xD;
&#xD;
          8. Known allergic reaction to the drugs used (see material and methods)&#xD;
&#xD;
          9. Intake of drugs known to accumulate intrahepatic lipids (e.g.&#xD;
             steroids/glucocorticoids, tamoxifen, amiodarone, perhexiline maleate, synthetic&#xD;
             estrogens, antiretroviral agents, tetracycline, minocycline, certain pesticides,&#xD;
             methotrexate)&#xD;
&#xD;
         10. Intake of drugs known to drive fibrosis/cirrhosis (e.g. azathioprine, oral&#xD;
             contraceptive pills)&#xD;
&#xD;
         11. Inability or contraindications to perform study procedures&#xD;
&#xD;
         12. General and absolute endoscopy contraindications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Trauner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Gastroenterology and Hepatology Department of Internal Medicine III Medical University of Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Vienna, General Hospital of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 1, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>September 24, 2015</last_update_submitted>
  <last_update_submitted_qc>September 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Prof. Michael Trauner, MD</investigator_full_name>
    <investigator_title>Professor, MD, Head and Chair of the Division of Gastroenterology and Hepatology, Department of Internal Medicine III</investigator_title>
  </responsible_party>
  <keyword>non-alcoholic fatty liver disease</keyword>
  <keyword>non-alcoholic steatohepatitis</keyword>
  <keyword>NAFLD</keyword>
  <keyword>NASH</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/NCT01696487
org study id: Fru1.0
nct id: NCT01696487
lead sponsor: 
collaborator: 
has dmc: Yes
The spectrum of NAFLD as emerging epidemic ranges from steatosis to steatohepatitis (NASH),
      cirrhosis and hepatocellular carcinoma (HCC). Disease progression is poorly understood and
      treatment options are limited. Fructose overconsumption has been associated with gut
      permeability and progression of NAFLD. To unravel the mechanisms of fructose-induced
      intestinal changes, volunteers will receive a 4-week fructose challenge prior to assessment
      of intestinal permeability/translocation using endomicroscopy, sugar probes, serum markers of
      intestinal damage, inflammation, iron/copper homeostasis and histological/molecular analysis
      of intestinal biopsies. Findings in volunteers will be compared with liver patients
      undergoing study procedures without fructose challenge. Translational in vitro experiments
      will explore cellular responses to fructose and endotoxin. This project should provide novel
      insights into dietary induced alterations of the gut integrity in progression of NAFLD to
      NASH.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Gaps per 1000 intestinal epithelial cells assessed by confocal laser endomicroscopy
time frame: Time point 1 (day 1 - all study groups)
description: Gaps per 1000 intestinal cells will be assesed during gastroscopy by confocal laser endomicroscopy at time point 1 in all study groups and after the 4 week fructose challange in healthy volunteers only
measure: Gaps per 1000 intestinal epithelial cells assessed by confocal laser endomicroscopy
time frame: point 2 (week4/day28 - after fructose challange; healthy volunteers only)
description: Gaps per 1000 intestinal cells will be assesed during gastroscopy by confocal laser endomicroscopy at time point 1 in all study groups and after the 4 week fructose challange in healthy volunteers only
arm group label: Healthy Volunteers
arm group type: Experimental
description: Volunteers will be challenged with oral 150g Fructose per day for 28 days.
arm group label: NAFLD
arm group type: No Intervention
description: Patients with confirmed fatty liver (imaging positive) will be compared at baseline with other arms.
arm group label: NASH
arm group type: No Intervention
description: Patients with confirmed non-alcoholic steatohepatitis (biopsy proven) will be compared at baseline with other arms.
arm group label: Hepatitis C genotype 1 (HCV-GT1)
arm group type: No Intervention
description: Patients with confirmed hepatitis C genotype 1 will be compared at baseline with other arms and act as different liver disease control group
intervention type: Dietary Supplement
intervention name: High oral Fructose challenge (150g per day for 28 days)
arm group label: Healthy Volunteers
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Trauner, MD
role: Principal Investigator
affiliation: Division of Gastroenterology and Hepatology Department of Internal Medicine III Medical University of Vienna
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Prof. Michael Trauner, MD
investigator title: Professor, MD, Head and Chair of the Division of Gastroenterology and Hepatology, Department of Internal Medicine III
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease