FGF21 and Its Role in Alcohol Dependence (AlcoDep)

University Hospital, Gentofte, Copenhagen

Status: Completed

Conditions: Alcohol Abuse or Dependence

Treatments: Other: Ethanol

Study type: Interventional

Funder types: Other

Identifiers

NCT03892369

H-18063495

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: Male

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Alcohol

Experimental group

Description:

The participant receive 0.5 g ethanol per kg body weight over 10 minutes. Subsequently blood samples are taken frequently the next ten hours.

Treatment:

Other: Ethanol