AlcoDep: FGF21 and Its Role in Alcohol Dependence

• Sponsor: University Hospital, Gentofte, Copenhagen (Other)
• Overall Status: Completed
• CT.gov ID: NCT03892369
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arm: 1
• Actual Duration (Months): 24
• Patients Per Site Per Month: 1.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Abuse or Dependence	Other: Ethanol	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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.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)
• Primary Purpose: Diagnostic
• Official Title: Physiological Effects of FGF21 in Humans and Its Pathophysiological Role in Alcohol Dependence
• Actual Study Start Date: Sep 1, 2019
• Actual Primary Completion Date: Jun 1, 2021
• Actual Study Completion Date: Sep 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Fibroblast growthfactor-21 [One year]

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

Secondary Outcome Measures

1. Ethanol [One year]

   Plasma ethanol concentration

2. Glucose [One year]

   Plasma glucose concentrations

3. Insulin and C-peptide [One year]

   Serum insulin and C-peptide concentrations

4. Glucagon [One year]

   Plasma glucagon concentration

5. Tumor Necrosis Factor-alpha (TNF) [One year]

   Plasma TNF-alpha concentrations

6. Lipopolysaccharide Binding Protein (LBP) [One year]

   Plasma LBP concentrations

7. Interferon-gamma (INF) [One year]

   Plasma INF-gamma concentrations

8. Interleukine-10 (IL-10) [One year]

   Plasma IL-10 concentrations

9. Interleukine-8 (IL-8) [One year]

   Plasma IL-8 concentrations

10. Interleukine-6 (IL-6) [One year]

    Plasma IL-6 concentrations

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Clinical Metabolic Research, Gentofte Hospital	Hellerup		Denmark	2900

Sponsors and Collaborators

• University Hospital, Gentofte, Copenhagen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Filip Krag Knop, Head of Clinical Metabolic Physiology, Principal Investigator, Clinical Professor, PhD, MD, University Hospital, Gentofte, Copenhagen
• ClinicalTrials.gov Identifier: NCT03892369
• Other Study ID Numbers: H-18063495
• First Posted: Mar 27, 2019
• Last Update Posted: Dec 2, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Filip Krag Knop, Head of Clinical Metabolic Physiology, Principal Investigator, Clinical Professor, PhD, MD, University Hospital, Gentofte, Copenhagen: Alcohol; FGF21; Alcohol dependence
• Additional relevant MeSH terms: Alcoholism; Ethanol

Study Results

No Results Posted as of Dec 2, 2021