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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Medical Scientific Fund of the Mayor of the City of Vienna
Information provided by (Responsible Party):
Prof. Michael Trauner, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01696487
First received: September 1, 2012
Last updated: September 28, 2012
Last verified: September 2012
  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: 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 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: February 2014
Estimated 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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696487

Contacts
Contact: Michael Trauner, Professor, MD +43140400 ext 4741 michael.trauner@meduniwien.ac.at
Contact: Petra Munda, Associate Professor, MD +43140400 ext 4741 petra.munda@meduniwien.ac.at

Locations
Austria
Medical University of Vienna, General Hospital of Vienna Recruiting
Vienna, Austria, 1090
Contact: Michael Trauner, Professor, MD    +43140400 ext 4741    michael.trauner@meduniwien.ac.at   
Contact: Petra Munda, Associate Professor, MD    +43140400 ext 4741    petra.munda@meduniwien.ac.at   
Sub-Investigator: Christian Kienbacher, MD         
Sub-Investigator: Werner Dolak, MD         
Sub-Investigator: Stefan Traussnigg, MD         
Sponsors and Collaborators
Medical University of Vienna
Medical Scientific Fund of the Mayor of the City of Vienna
Investigators
Principal Investigator: Michael Trauner, Professor, MD Division of Gastroenterology and Hepatology Department of Internal Medicine III Medical University of Vienna
  More Information

No publications provided

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
Study First Received: September 1, 2012
Last Updated: September 28, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
non-alcoholic fatty liver disease
non-alcoholic steatohepatitis
NAFLD
NASH

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on November 25, 2014