<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/NCT01705171</url>
  </required_header>
  <id_info>
    <org_study_id>GGP1345012</org_study_id>
    <secondary_id>GLUT5</secondary_id>
    <nct_id>NCT01705171</nct_id>
  </id_info>
  <brief_title>Is the Expression of the GLUT5 Specific Fructose Transport Protein Abnormal in Patients With Fructose Intolerance?</brief_title>
  <official_title>Is the Expression of the GLUT5 Specific Fructose Transport Protein Abnormal in Patients With Fructose Intolerance?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brain-Gut Research Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brain-Gut Research Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study we will investigate the expression of the fructose transport protein GLUT5 in&#xD;
      the small intestine in patients with functional GI disoders and fructose intolerance compared&#xD;
      to matched healthy controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intolerances to food are a major complaint of patients with functional gastrointestinal&#xD;
      disorders (FGID) and even commoner in patients with inflammatory bowel disorders (IBD)&#xD;
      (Barrett JS et al. Aliment Pharmacol Therap 2009;30:165-174). The most common forms of food&#xD;
      intolerance are FODMAP (fermentable oligo-, di- and monosaccharide and polyol) -related, of&#xD;
      which fructose and lactose are the best known. The prevalence of lactose and fructose&#xD;
      intolerance in IBS patients is between 50 and 70% (Wilder-Smith CH et al. Gastroenterology&#xD;
      2009;136 (Suppl. 1): A324). Recent high quality studies have shown that the reduction of&#xD;
      ingested FODMAP can lead to significant and long-term symptom improvement in patients shown&#xD;
      to be intolerant by breath-testing. While the pathophysiology behind lactose intolerance is&#xD;
      the reduction in small intestinal lactase availability, the mechanism in fructose intolerance&#xD;
      and its relationship to malabsorption are unknown. One possible and so far uninvestigated&#xD;
      mechanism is a reduction in the expression or activity of the specific fructose transporter,&#xD;
      GLUT5, which is mainly responsible for luminal absorption of fructose. GLUT5 is mainly found&#xD;
      in the small intestine, as well as various extra-intestinal organs. The clinical relevance of&#xD;
      GLUT5 expression for food intolerances in humans has not been reported, but in a mouse model&#xD;
      deletion of GLUT5 led to decreased absorption of dietary fructose and typical signs of&#xD;
      malabsorption (Barone S et al. J Biol Chem 2009;284:5056-5066). The control of GLUT5 is&#xD;
      dynamic and considerable upregulation together with increased absorption of fructose is&#xD;
      evident in diabetes mellitus, while expression is decreased by inflammation and&#xD;
      lipopolysaccharide endotoxin, an integral component of the outer membrane of all&#xD;
      gram-negative bacteria, through the action of pro-inflammatory cytokines, such as TFN-a.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>mRNA and protein expression of Glut5</measure>
    <time_frame>on day of endoscopy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>mRNA and protein expression of Glut2</measure>
    <time_frame>on day of endoscopy</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">26</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <condition>Fructose Intolerance</condition>
  <arm_group>
    <arm_group_label>IBS patients with fructose intolerance</arm_group_label>
    <description>analysis of biopsies</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group: no IBS or fructose intolerance</arm_group_label>
    <description>analysis of biopsies</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients referred to our practice for evaluation of symptoms consistent with FGID&#xD;
        undergoing upper GI endoscopy with biopsy and fructose breath testing as part of their&#xD;
        usual clinical evaluation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients referred to our practice for evaluation of symptoms consistent with FGID&#xD;
             undergoing upper GI endoscopy with biopsy and fructose breath testing as part of their&#xD;
             usual clinical evaluation. Male or female patients aged between 18 and 60 years with&#xD;
             FGID (Irritable Bowel Syndrome (IBS), Functional Dyspepsia (FD) or Functional Bloating&#xD;
             (FB), as defined by Rome III criteria.&#xD;
&#xD;
          -  Successive patients without fructose intolerance undergoing upper GI endoscopy for&#xD;
             other reasons without inflammatory disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inflammatory GI disease, coeliac's disease, other relevant systemic disorders as&#xD;
             judged by investigator, concomitant antiinflammtory treatments, absent informed&#xD;
             consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>C Wilder-Smith, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brain-Gut Research Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gastoenterology Group Practice</name>
      <address>
        <city>Bern</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>December 14, 2018</last_update_submitted>
  <last_update_submitted_qc>December 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brain-Gut Research Group</investigator_affiliation>
    <investigator_full_name>C. Wilder-Smith</investigator_full_name>
    <investigator_title>Dr. med.</investigator_title>
  </responsible_party>
  <keyword>IBS</keyword>
  <keyword>fructose intolerance</keyword>
  <keyword>GLUT 5</keyword>
  <keyword>GLUT 2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Fructose Intolerance</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/NCT01705171
org study id: GGP1345012
secondary id: GLUT5
nct id: NCT01705171
lead sponsor: 
has dmc: No
In this study we will investigate the expression of the fructose transport protein GLUT5 in
      the small intestine in patients with functional GI disoders and fructose intolerance compared
      to matched healthy controls.
Intolerances to food are a major complaint of patients with functional gastrointestinal
      disorders (FGID) and even commoner in patients with inflammatory bowel disorders (IBD)
      (Barrett JS et al. Aliment Pharmacol Therap 2009;30:165-174). The most common forms of food
      intolerance are FODMAP (fermentable oligo-, di- and monosaccharide and polyol) -related, of
      which fructose and lactose are the best known. The prevalence of lactose and fructose
      intolerance in IBS patients is between 50 and 70% (Wilder-Smith CH et al. Gastroenterology
      2009;136 (Suppl. 1): A324). Recent high quality studies have shown that the reduction of
      ingested FODMAP can lead to significant and long-term symptom improvement in patients shown
      to be intolerant by breath-testing. While the pathophysiology behind lactose intolerance is
      the reduction in small intestinal lactase availability, the mechanism in fructose intolerance
      and its relationship to malabsorption are unknown. One possible and so far uninvestigated
      mechanism is a reduction in the expression or activity of the specific fructose transporter,
      GLUT5, which is mainly responsible for luminal absorption of fructose. GLUT5 is mainly found
      in the small intestine, as well as various extra-intestinal organs. The clinical relevance of
      GLUT5 expression for food intolerances in humans has not been reported, but in a mouse model
      deletion of GLUT5 led to decreased absorption of dietary fructose and typical signs of
      malabsorption (Barone S et al. J Biol Chem 2009;284:5056-5066). The control of GLUT5 is
      dynamic and considerable upregulation together with increased absorption of fructose is
      evident in diabetes mellitus, while expression is decreased by inflammation and
      lipopolysaccharide endotoxin, an integral component of the outer membrane of all
      gram-negative bacteria, through the action of pro-inflammatory cytokines, such as TFN-a.
observational model: Case-Control
time perspective: Prospective
measure: mRNA and protein expression of Glut5
time frame: on day of endoscopy
measure: mRNA and protein expression of Glut2
time frame: on day of endoscopy
arm group label: IBS patients with fructose intolerance
description: analysis of biopsies
arm group label: Control group: no IBS or fructose intolerance
description: analysis of biopsies
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: C Wilder-Smith, MD
role: Principal Investigator
affiliation: Brain-Gut Research Group
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Brain-Gut Research Group
investigator full name: C. Wilder-Smith
investigator title: Dr. med.
mesh term: Irritable Bowel Syndrome
mesh term: Fructose Intolerance