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Is the Expression of the GLUT5 Specific Fructose Transport Protein Abnormal in Patients With Fructose Intolerance?

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ClinicalTrials.gov Identifier: NCT01705171
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
C. Wilder-Smith, Brain-Gut Research Group

Tracking Information
First Submitted Date October 9, 2012
First Posted Date October 12, 2012
Last Update Posted Date December 17, 2018
Study Start Date December 2011
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 11, 2012)
mRNA and protein expression of Glut5 [ Time Frame: on day of endoscopy ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01705171 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 11, 2012)
mRNA and protein expression of Glut2 [ Time Frame: on day of endoscopy ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Is the Expression of the GLUT5 Specific Fructose Transport Protein Abnormal in Patients With Fructose Intolerance?
Official Title Is the Expression of the GLUT5 Specific Fructose Transport Protein Abnormal in Patients With Fructose Intolerance?
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients referred to our practice for evaluation of symptoms consistent with FGID undergoing upper GI endoscopy with biopsy and fructose breath testing as part of their usual clinical evaluation.
Condition
  • Irritable Bowel Syndrome
  • Fructose Intolerance
Intervention Not Provided
Study Groups/Cohorts
  • IBS patients with fructose intolerance
    analysis of biopsies
  • Control group: no IBS or fructose intolerance
    analysis of biopsies
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 14, 2018)
26
Original Estimated Enrollment
 (submitted: October 11, 2012)
20
Actual Study Completion Date October 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients referred to our practice for evaluation of symptoms consistent with FGID undergoing upper GI endoscopy with biopsy and fructose breath testing as part of their usual clinical evaluation. Male or female patients aged between 18 and 60 years with FGID (Irritable Bowel Syndrome (IBS), Functional Dyspepsia (FD) or Functional Bloating (FB), as defined by Rome III criteria.
  • Successive patients without fructose intolerance undergoing upper GI endoscopy for other reasons without inflammatory disease

Exclusion Criteria:

  • Inflammatory GI disease, coeliac's disease, other relevant systemic disorders as judged by investigator, concomitant antiinflammtory treatments, absent informed consent.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01705171
Other Study ID Numbers GGP1345012
GLUT5 ( Other Identifier: Brain-Gut Research Group )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party C. Wilder-Smith, Brain-Gut Research Group
Study Sponsor Brain-Gut Research Group
Collaborators Not Provided
Investigators
Principal Investigator: C Wilder-Smith, MD Brain-Gut Research Group
PRS Account Brain-Gut Research Group
Verification Date December 2018