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FGF21 and Its Role in Alcohol Dependence (AlcoDep)

Primary Purpose

Alcohol Abuse or Dependence

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Ethanol
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alcohol Abuse or Dependence focused on measuring Alcohol, FGF21, Alcohol dependence

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Center for Clinical Metabolic Research, Gentofte Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alcohol

Arm Description

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

Outcomes

Primary Outcome Measures

Fibroblast growthfactor-21
Plasma FGF21 concentrations, a member of the endocrine FGF-family

Secondary Outcome Measures

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

Full Information

First Posted
March 22, 2019
Last Updated
December 1, 2021
Sponsor
University Hospital, Gentofte, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT03892369
Brief Title
FGF21 and Its Role in Alcohol Dependence
Acronym
AlcoDep
Official Title
Physiological Effects of FGF21 in Humans and Its Pathophysiological Role in Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse or Dependence
Keywords
Alcohol, FGF21, Alcohol dependence

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alcohol
Arm Type
Experimental
Arm Description
The participant receive 0.5 g ethanol per kg body weight over 10 minutes. Subsequently blood samples are taken frequently the next ten hours.
Intervention Type
Other
Intervention Name(s)
Ethanol
Intervention Description
Ethanol administration
Primary Outcome Measure Information:
Title
Fibroblast growthfactor-21
Description
Plasma FGF21 concentrations, a member of the endocrine FGF-family
Time Frame
One year
Secondary Outcome Measure Information:
Title
Ethanol
Description
Plasma ethanol concentration
Time Frame
One year
Title
Glucose
Description
Plasma glucose concentrations
Time Frame
One year
Title
Insulin and C-peptide
Description
Serum insulin and C-peptide concentrations
Time Frame
One year
Title
Glucagon
Description
Plasma glucagon concentration
Time Frame
One year
Title
Tumor Necrosis Factor-alpha (TNF)
Description
Plasma TNF-alpha concentrations
Time Frame
One year
Title
Lipopolysaccharide Binding Protein (LBP)
Description
Plasma LBP concentrations
Time Frame
One year
Title
Interferon-gamma (INF)
Description
Plasma INF-gamma concentrations
Time Frame
One year
Title
Interleukine-10 (IL-10)
Description
Plasma IL-10 concentrations
Time Frame
One year
Title
Interleukine-8 (IL-8)
Description
Plasma IL-8 concentrations
Time Frame
One year
Title
Interleukine-6 (IL-6)
Description
Plasma IL-6 concentrations
Time Frame
One year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filip K Knop, MD
Organizational Affiliation
Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Clinical Metabolic Research, Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

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FGF21 and Its Role in Alcohol Dependence

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