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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00013942 |
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Date of registration:
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30/01/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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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Date of first enrolment:
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01/06/2009 |
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Target sample size:
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42 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00013942 |
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Study type:
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interventional |
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Study design:
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Allocation: Non-randomized controlled study; Masking: Open (masking not used); Control: Other; Assignment: parallel; Study design purpose: basic science
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Frank
Lammert |
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Address:
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Kirrbergerstr.
66421
Homburg/Saar
Germany |
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Telephone:
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+49-6481-16-23202 |
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Email:
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frank.lammert@uks.eu |
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Affiliation:
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Universitätsklinikum des SaarlandesKlinik für Innere Medizin II |
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Name:
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Frank
Lammert |
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Address:
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Kirrbergerstr.
66421
Homburg/Saar
Germany |
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Telephone:
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+49-6481-16-23202 |
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Email:
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frank.lammert@uks.eu |
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Affiliation:
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Universitätsklinikum des SaarlandesKlinik für Innere Medizin II |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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E66.0
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K76.0
E66.0
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K76.0
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Obesity due to excess calories
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Fatty (change of) liver, not elsewhere classified
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Intervention(s)
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Group 1: 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
Group 2: 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
Group 3: 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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Primary Outcome(s)
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Fasting FGF19 serum concentration and 2, 4 and 6 hours after body-weight-adjusted oral fat load
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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Universität des Saarlandes
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Ethics review
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Status: Approved
Approval date: 28/04/2009
Contact:
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