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Completed

NCT Number: NCT03892369

FGF21 and Its Role in Alcohol Dependence

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.

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Key information

Conditions

Alcohol Abuse or Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

25 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ethanol

Other

Ethanol administration

Primary outcomes

  1. Fibroblast growthfactor-21

    Time frame: One year

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

Secondary outcomes

  1. Ethanol

    Time frame: One year

    Plasma ethanol concentration

  2. Glucose

    Time frame: One year

    Plasma glucose concentrations

  3. Insulin and C-peptide

    Time frame: One year

    Serum insulin and C-peptide concentrations

  4. Glucagon

    Time frame: One year

    Plasma glucagon concentration

  5. Tumor Necrosis Factor-alpha (TNF)

    Time frame: One year

    Plasma TNF-alpha concentrations

  6. Lipopolysaccharide Binding Protein (LBP)

    Time frame: One year

    Plasma LBP concentrations

  7. Interferon-gamma (INF)

    Time frame: One year

    Plasma INF-gamma concentrations

  8. Interleukine-10 (IL-10)

    Time frame: One year

    Plasma IL-10 concentrations

  9. Interleukine-8 (IL-8)

    Time frame: One year

    Plasma IL-8 concentrations

  10. Interleukine-6 (IL-6)

    Time frame: One year

    Plasma IL-6 concentrations

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

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

Acronym: AlcoDep

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 27, 2019
Registry last updated
Dec 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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