Studies on the gastrointestinal hormone fibroblast growth factor 19 (FGF19) in overweight and obese patients with non-alcoholic fatty liver diseases (NAFLD)

Not Applicable

• Conditions: K76.0; E66.0; Fatty (change of) liver, not elsewhere classified; Obesity due to excess calories

• Registration Number: DRKS00013942
• Lead Sponsor: niversität des Saarlandes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2010-12-20
• Study Start: 2018-01-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

written consent,
Age: >18 years,
Controls: healthy and normal weight (BMI
19.0-25.4 kg / m²),
overweight subjects (BMI 25.5-29.9 kg/m²) + NAFLD,
obese subjects (BMI = 30 kg m²) + NAFLD,
Liver diagnostics in overweight and
obese by ultrasound and/or liver biopsy

Exclusion Criteria

missing declaration of consent,
NAFLD patients: increased alcohol consumption in medical history and the following acute and chronic liver diseases: cirrhosis, hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis D virus (HDV), cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) infections, hemochromatosis, Wilson's disease, a1-antitrypsin deficiency, and autoimmune hepatitis.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fasting FGF19 serum concentration and 2, 4 and 6 hours after body-weight-adjusted oral fat load

Secondary Outcome Measures

Name	Time	Method
Concentrations of bile acids and bile acid synthesis marker 7a-hydroxy-4-cholesten-3-one (C4) are measured by gas chromatography-mass spectrometry and high-performance liquid chromatography, respectively; all at 0 (baseline), 2, 4 and 6 hours during the OFTT.