FGF21 and Its Role in Alcohol Dependence

NCT03892369 | Completed

• 1 other identifier: H-18063495
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Abuse or Dependence

Keywords

Alcohol; FGF21; Alcohol dependence

Outcome Measures

Primary Outcomes (1)

• Fibroblast growthfactor-21

  Plasma FGF21 concentrations, a member of the endocrine FGF-family

  One year

Secondary Outcomes (10)

• Ethanol

  One year

• Glucose

  One year

• Insulin and C-peptide

  One year

• Glucagon

  One year

• Tumor Necrosis Factor-alpha (TNF)

  One year

Study Arms (1)

Alcohol

EXPERIMENTAL

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

Other: Ethanol

Interventions

Ethanol OTHER

Ethanol administration

Alcohol

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Filip K Knop, MD

  Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinical Metabolic Physiology, Principal Investigator, Clinical Professor, PhD, MD

Model Details: 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.

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: March 27, 2019
• Study Start: September 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: December 2, 2021

Record last verified: 2021-12

Locations

DK (1)