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

NCT ID: NCT01696487

Last Updated: 2015-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-02-28

Brief 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.

Conditions

Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Healthy Volunteers

Volunteers will be challenged with oral 150g Fructose per day for 28 days.

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

NAFLD

Patients with confirmed fatty liver (imaging positive) will be compared at baseline with other arms.

Group Type: NO_INTERVENTION

No interventions assigned to this group

NASH

Patients with confirmed non-alcoholic steatohepatitis (biopsy proven) will be compared at baseline with other arms.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Prof. Michael Trauner, MD

Professor, MD, Head and Chair of the Division of Gastroenterology and Hepatology, Department of Internal Medicine III

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Trauner, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Gastroenterology and Hepatology Department of Internal Medicine III Medical University of Vienna

Locations

Medical University of Vienna, General Hospital of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

Fru1.0

Identifier Type: -

Identifier Source: org_study_id