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Impact of Fructose Consumption on Intestinal Permeability in Non-alcoholic Fatty Liver Disease (NAFLD) - a Pilot Study.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01696487
First Posted: October 1, 2012
Last Update Posted: September 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
State Government of Vienna, Austria (Medizinisch-Wissenschaftlicher Fonds des Bürgermeisters der Bundeshauptstadt Wien)
Information provided by (Responsible Party):
Prof. Michael Trauner, MD, Medical University of Vienna
  Purpose
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.

Condition Intervention
Non-alcoholic Fatty Liver Disease Non-alcoholic Steatohepatitis Dietary Supplement: High oral Fructose challenge (150g per day for 28 days)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Fructose Consumption on Intestinal Permeability in Non-alcoholic Fatty Liver Disease (NAFLD) - a Pilot Study.

Resource links provided by NLM:


Further study details as provided by Prof. Michael Trauner, MD, Medical University of Vienna:

Primary Outcome Measures:
  • Gaps per 1000 intestinal epithelial cells assessed by confocal laser endomicroscopy [ Time Frame: Time point 1 (day 1 - all study groups) ]
    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

  • Gaps per 1000 intestinal epithelial cells assessed by confocal laser endomicroscopy [ Time Frame: point 2 (week4/day28 - after fructose challange; healthy volunteers only) ]
    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


Enrollment: 10
Study Start Date: February 2012
Study Completion Date: February 2014
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy Volunteers
Volunteers will be challenged with oral 150g Fructose per day for 28 days.
Dietary Supplement: High oral Fructose challenge (150g per day for 28 days)
No Intervention: NAFLD
Patients with confirmed fatty liver (imaging positive) will be compared at baseline with other arms.
No Intervention: NASH
Patients with confirmed non-alcoholic steatohepatitis (biopsy proven) will be compared at baseline with other arms.
No Intervention: Hepatitis C genotype 1 (HCV-GT1)
Patients with confirmed hepatitis C genotype 1 will be compared at baseline with other arms and act as different liver disease control group

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  1. Healthy men and women from 18 to 85, no disease history, no intake of regular medication.
  2. Patients with confirmed (at least one imaging positive) intrahepatic fat accumulation (NAFL), male and female
  3. Patients with confirmed NASH (biopsy within 6 months prior to study), male and female
  4. Diagnosed HCV, genotype 1, male and female

Signed informed consent

General exclusion criteria (for all groups)

  1. Pregnancy and lactation
  2. Imprisoned persons
  3. Inflammatory bowel conditions (celiac disease, Crohn's disease, ulcerative colitis)
  4. Prior bariatric surgery
  5. Alcoholic steatohepatitis and/or alcohol consumption > 140 gramms per week (or > 30g/day)
  6. Other liver diseases (autoimmune, genetic, cholestatic, Wilson disease, Weber-Christian disease, partial lipodystrophy of the face sparing type, abetalipoproteinemia, and jejunal diverticulosis with bacterial overgrowth.)
  7. Virus hepatitis (A, B, C) (except for group (4): defined as HCV, genotype 1)
  8. Known allergic reaction to the drugs used (see material and methods)
  9. Intake of drugs known to accumulate intrahepatic lipids (e.g. steroids/glucocorticoids, tamoxifen, amiodarone, perhexiline maleate, synthetic estrogens, antiretroviral agents, tetracycline, minocycline, certain pesticides, methotrexate)
  10. Intake of drugs known to drive fibrosis/cirrhosis (e.g. azathioprine, oral contraceptive pills)
  11. Inability or contraindications to perform study procedures
  12. General and absolute endoscopy contraindications
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696487


Locations
Austria
Medical University of Vienna, General Hospital of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
State Government of Vienna, Austria (Medizinisch-Wissenschaftlicher Fonds des Bürgermeisters der Bundeshauptstadt Wien)
Investigators
Principal Investigator: Michael Trauner, MD Division of Gastroenterology and Hepatology Department of Internal Medicine III Medical University of Vienna
  More Information

Responsible Party: Prof. Michael Trauner, MD, Professor, MD, Head and Chair of the Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01696487     History of Changes
Other Study ID Numbers: Fru1.0
First Submitted: September 1, 2012
First Posted: October 1, 2012
Last Update Posted: September 28, 2015
Last Verified: September 2015

Keywords provided by Prof. Michael Trauner, MD, Medical University of Vienna:
non-alcoholic fatty liver disease
non-alcoholic steatohepatitis
NAFLD
NASH

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases