FGF21 and Its Role in Alcohol Dependence (NCT03892369) | Clinical Trial Compass
CompletedNot Applicable
FGF21 and Its Role in Alcohol Dependence
Denmark45 participantsStarted 2019-09-01
Plain-language summary
Plasma fibroblast growthfactor-21 (FGF21) responses to acute alcohol exposure will be evaluated in three groups: A: 15 individuals diagnosed with alcohol dependence (ICD10 code F10.2) and no alcoholic liver diseases, B: 15 healthy individuals with one or two parents with alcohol dependence, and C: 15 healthy matched controls without history of or disposition to alcohol dependence. The experimental day consists of a load of 0.5 g ethanol per kg body weight ingested from time 0-10 minutes followed by a 7 h period in which blood will be sampled with frequent intervals, rating of preference for ethanol, salt, sour, bitterly and sweets, sensations of hunger, appetite, satiety, headache, and nausea will be evaluated using visuel analogue scale and resting energy expenditure will be evaluated using indirect calorimetry.
Who can participate
Age range25 Years – 65 Years
SexMALE
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Inclusion Criteria:
* Informed consent
* Caucasian males between 25 and 65 years of age
* BMI between 19 and 27 kg/m2
* Normal haemoglobin
* Normal fasting plasma glucose concentration (\< 6 mmol/l) and normal glycated haemoglobin A1c (HbA1c) (\< 42 mmol/mol)
Participants with a father diagnosed with alcohol dependence (group B):
* Father diagnosed with alcohol dependence
* Weekly alcohol intake of less than 14 units of alcohol (of 12 g)
* Normal Alcohol Use Disorders Identification Test (AUDIT) score
Healthy participants (group C):
* Weekly alcohol intake of less than 14 units of alcohol (of 12 g)
* Normal AUDIT score
Exclusion Criteria:
* Liver disease evaluated by plasma alanine aminotransferase (ALAT) \> 3 × normal level, an international normalised ratio (INR) below normal values, or biopsy-verified alcoholic liver disease
* Diabetes mellitus
* Anaemia
* Nephropathy
* Other diseases the investigator finds disruptive for participation in the study.
Participants with a father diagnosed with alcohol dependence (group B):
\- Former alcohol dependence or abuse
Healthy participants (group C):
* First-degree relatives with diabetes, liver disease and/or alcohol dependence
* Former alcohol dependence