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

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Steatohepatitis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna, General Hospital of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Healthy men and women from 18 to 85, no disease history, no intake of regular medication.
Patients with confirmed (at least one imaging positive) intrahepatic fat accumulation (NAFL), male and female
Patients with confirmed NASH (biopsy within 6 months prior to study), male and female
Diagnosed HCV, genotype 1, male and female

Signed informed consent

General exclusion criteria (for all groups)

Pregnancy and lactation
Imprisoned persons
Inflammatory bowel conditions (celiac disease, Crohn's disease, ulcerative colitis)
Prior bariatric surgery
Alcoholic steatohepatitis and/or alcohol consumption > 140 gramms per week (or > 30g/day)
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.)
Virus hepatitis (A, B, C) (except for group (4): defined as HCV, genotype 1)
Known allergic reaction to the drugs used (see material and methods)
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)
Intake of drugs known to drive fibrosis/cirrhosis (e.g. azathioprine, oral contraceptive pills)
Inability or contraindications to perform study procedures
General and absolute endoscopy contraindications

Treatment and study plan

High oral Fructose challenge (150g per day for 28 days)

Dietary Supplement

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

State Government of Vienna, Austria (Medizinisch-Wissenschaftlicher Fonds des Bürgermeisters der Bundeshauptstadt Wien)

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2014
First posted: Oct 1, 2012
Registry last updated: Sep 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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