FGF21 and Its Role in Alcohol Dependence (AlcoDep)

December 1, 2021 updated by: Filip Krag Knop, University Hospital, Gentofte, Copenhagen

Physiological Effects of FGF21 in Humans and Its Pathophysiological 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • Center for Clinical Metabolic Research, Gentofte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Ethanol
Ethanol administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibroblast growthfactor-21
Time Frame: One year
Plasma FGF21 concentrations, a member of the endocrine FGF-family
One year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Investigators

  • Principal Investigator: Filip K Knop, MD, Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

March 22, 2019

First Submitted That Met QC Criteria

March 26, 2019

First Posted (Actual)

March 27, 2019

Study Record Updates

Last Update Posted (Actual)

December 2, 2021

Last Update Submitted That Met QC Criteria

December 1, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-18063495

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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