FGF21 and Its Role in Alcohol Dependence

NCT ID: NCT03892369

Last Updated: 2021-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2021-09-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Alcohol

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

Group Type: EXPERIMENTAL

Ethanol

Intervention Type: OTHER

Ethanol administration

Interventions

Ethanol

Ethanol administration

Intervention Type: OTHER

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Filip Krag Knop

Head of Clinical Metabolic Physiology, Principal Investigator, Clinical Professor, PhD, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Filip K Knop, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen

Locations

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, , Denmark

Countries

Denmark

Other Identifiers

H-18063495

Identifier Type: -

Identifier Source: org_study_id