FGF21 and Its Role in Alcohol Dependence

Not Applicable

Completed

• Conditions: Alcohol Abuse or Dependence
• Interventions: Other: Ethanol

• Registration Number: NCT03892369
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-27
• Study Start: 2019-09-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-09-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Fibroblast growthfactor-21	One year	Plasma FGF21 concentrations, a member of the endocrine FGF-family

Secondary Outcome Measures

Name	Time	Method
Ethanol	One year	Plasma ethanol concentration
Glucose	One year	Plasma glucose concentrations
Insulin and C-peptide	One year	Serum insulin and C-peptide concentrations
Glucagon	One year	Plasma glucagon concentration
Lipopolysaccharide Binding Protein (LBP)	One year	Plasma LBP concentrations
Tumor Necrosis Factor-alpha (TNF)	One year	Plasma TNF-alpha concentrations
Interferon-gamma (INF)	One year	Plasma INF-gamma concentrations
Interleukine-8 (IL-8)	One year	Plasma IL-8 concentrations
Interleukine-6 (IL-6)	One year	Plasma IL-6 concentrations
Interleukine-10 (IL-10)	One year	Plasma IL-10 concentrations

Trial Locations

Locations (1)

Center for Clinical Metabolic Research, Gentofte Hospital; 🇩🇰 Hellerup, Denmark