Clinical trial NCT03892369: FGF21 and Its Role in Alcohol Dependence
Official title: Physiological Effects of FGF21 in Humans and Its Pathophysiological Role in Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse or Dependence
Keywords: Alcohol
FGF21
Alcohol dependence
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 45
Sex: MALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Three matched groups. Group A: participants diagnosed with alcohol dependence, group B: participants with a father diagnosed with alcohol dependence, and C: a healthy control group.
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Fibroblast growthfactor-21
timeFrame: One year
Secondary outcomes:
measure: Ethanol
timeFrame: One year
measure: Glucose
timeFrame: One year
measure: Insulin and C-peptide
timeFrame: One year
measure: Glucagon
timeFrame: One year
measure: Tumor Necrosis Factor-alpha (TNF)
timeFrame: One year
measure: Lipopolysaccharide Binding Protein (LBP)
timeFrame: One year
measure: Interferon-gamma (INF)
timeFrame: One year
measure: Interleukine-10 (IL-10)
timeFrame: One year
measure: Interleukine-8 (IL-8)
timeFrame: One year
measure: Interleukine-6 (IL-6)
timeFrame: One year
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Center for Clinical Metabolic Research, Gentofte Hospital
Study officials:
affiliation: Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen
name: Filip K Knop, MD
role: PRINCIPAL_INVESTIGATOR
References: