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

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696487
• Other study ID #: Fru1.0
• Status: Completed
• Phase: N/A
• First received: September 1, 2012
• Last updated: September 24, 2015
• Start date: February 2012
• Est. completion date: February 2014

Study information

• Verified date: September 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2014
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis

Intervention

Dietary Supplement:
• High oral Fructose challenge (150g per day for 28 days)

Locations

Country	Name	City	State
Austria	Medical University of Vienna, General Hospital of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	State Government of Vienna, Austria (Medizinisch-Wissenschaftlicher Fonds des Bürgermeisters der Bundeshauptstadt Wien)

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gaps per 1000 intestinal epithelial cells assessed by confocal laser endomicroscopy	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	Time point 1 (day 1 - all study groups)	No
Primary	Gaps per 1000 intestinal epithelial cells assessed by confocal laser endomicroscopy	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	point 2 (week4/day28 - after fructose challange; healthy volunteers only)	No