Trial document





This trial has been registered retrospectively.
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  DRKS00013942

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Background: Excess nutrition and resulting overweight and obesity are the most important risk factors for developing NAFLD. Experimental and clinical studies show that the novel gastrointestinal hormone Fibroblast Growth Factor 19 (FGF19) could possibly play a beneficial role in NAFLD by increasing hepatic β-oxidation and simultaneously inhibiting triglyceride synthesis. The aim of our study was to investigate FGF19 serum concentrations in overweight (BMI ≥ 25.5 kg/m²) and obese (BMI > 30.0 kg/m²) NAFLD patients, and compare these to healthy volunteers in a fasted state and after a defined oral fat load. Furthermore, we investigated whether basic biochemistry, nutrition, BMI, body composition, age or sex influence FGF19 concentrations.
Patients and methods: We recruited NAFLD patients [overweight and obese as well as healthy controls. Total energy and macronutrients will be calculated from 3-day food diaries (EBISpro®). Body composition will be assessed using bioimpedance analysis (BIA). Serum FGF19 values willbe determined by ELISA after 10 hours of overnight fasting. Subsequently, all individuals will receive 1g fat (100ml=450 kcal; 0,0g protein, 0,0g carbohydrates, 50g vegetable fat) per kg body weight orally. FGF19 and triglyceride concentrations will be measured after 2, 4, and 6 hours.

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Organizational Data

  •   DRKS00013942
  •   2018/01/30
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  •   yes
  •   Approved
  •   58/09, Ethik-Kommission bei der Ärztekammer des Saarlandes
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Secondary IDs

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Health Condition or Problem studied

  •   K76.0 -  Fatty (change of) liver, not elsewhere classified
  •   E66.0 -  Obesity due to excess calories
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Interventions/Observational Groups

  •   Comparison of serum FGF19 concentrations between overweight and obese NAFLD patients and healthy subjects (fasted and after oral fat load)

    Group 1: overweight NAFLD subjects
  •   Comparison of serum FGF19 concentrations between overweight and obese NAFLD patients and healthy subjects (fasted and after oral fat load)

    Group 2: obese NAFLD subjects
  •   Comparison of serum FGF19 concentrations between overweight and obese NAFLD patients and healthy subjects (fasted and after oral fat load)


    Group 3: healthy volunteers
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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

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Secondary Outcome

Concentrations of bile acids and bile acid synthesis marker 7α-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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2009/06/01
  •   42
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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, α1-antitrypsin deficiency, and autoimmune hepatitis.

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Addresses

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    • Universität des Saarlandes
    • Campus Saarbrücken
    • 66123  Saarbrücken
    • Germany
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    • Universitätsklinikum des SaarlandesKlinik für Innere Medizin II
    • Mr.  Univ. Prof. Dr.  Frank  Lammert 
    • Kirrbergerstr.
    • 66421  Homburg/Saar
    • Germany
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    • Universitätsklinikum des SaarlandesKlinik für Innere Medizin II
    • Mr.  Univ. Prof. Dr.  Frank  Lammert 
    • Kirrbergerstr.
    • 66421  Homburg/Saar
    • Germany
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Sources of Monetary or Material Support

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    • Universität des Saarlandes
    • Campus Saarbrücken
    • 66123  Saarbrücken
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2010/12/20
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Trial Publications, Results and other Documents

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