FGF21 and Its Role in Alcohol Dependence

Alcohol Abuse or Dependence Clinical Trial

— AlcoDep  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03892369
• Other study ID #: H-18063495
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: December 2021
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Abuse or Dependence
• Alcoholism

Intervention

Other:
• Ethanol
Ethanol administration

Locations

Country	Name	City	State
Denmark	Center for Clinical Metabolic Research, Gentofte Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibroblast growthfactor-21	Plasma FGF21 concentrations, a member of the endocrine FGF-family	One year
Secondary	Ethanol	Plasma ethanol concentration	One year
Secondary	Glucose	Plasma glucose concentrations	One year
Secondary	Insulin and C-peptide	Serum insulin and C-peptide concentrations	One year
Secondary	Glucagon	Plasma glucagon concentration	One year
Secondary	Tumor Necrosis Factor-alpha (TNF)	Plasma TNF-alpha concentrations	One year
Secondary	Lipopolysaccharide Binding Protein (LBP)	Plasma LBP concentrations	One year
Secondary	Interferon-gamma (INF)	Plasma INF-gamma concentrations	One year
Secondary	Interleukine-10 (IL-10)	Plasma IL-10 concentrations	One year
Secondary	Interleukine-8 (IL-8)	Plasma IL-8 concentrations	One year
Secondary	Interleukine-6 (IL-6)	Plasma IL-6 concentrations	One year