Skip to content

FGF21 and Its Role in Alcohol Dependence

Physiological Effects of FGF21 in Humans and Its Pathophysiological Role in Alcohol Dependence

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03892369
Acronym
AlcoDep
Enrollment
45
Registered
2019-03-27
Start date
2019-09-01
Completion date
2021-09-01
Last updated
2021-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Abuse or Dependence

Keywords

Alcohol, FGF21, Alcohol dependence

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.

Interventions

OTHEREthanol

Ethanol administration

Sponsors

University Hospital, Gentofte, Copenhagen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

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.

Eligibility

Sex/Gender
MALE
Age
25 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Fibroblast growthfactor-21One yearPlasma FGF21 concentrations, a member of the endocrine FGF-family

Secondary

MeasureTime frameDescription
GlucoseOne yearPlasma glucose concentrations
Insulin and C-peptideOne yearSerum insulin and C-peptide concentrations
GlucagonOne yearPlasma glucagon concentration
Tumor Necrosis Factor-alpha (TNF)One yearPlasma TNF-alpha concentrations
EthanolOne yearPlasma ethanol concentration
Interferon-gamma (INF)One yearPlasma INF-gamma concentrations
Interleukine-10 (IL-10)One yearPlasma IL-10 concentrations
Interleukine-8 (IL-8)One yearPlasma IL-8 concentrations
Interleukine-6 (IL-6)One yearPlasma IL-6 concentrations
Lipopolysaccharide Binding Protein (LBP)One yearPlasma LBP concentrations

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026