MedDataX Logo

FGF21 and Its Role in Alcohol Dependence

NCT ID: NCT03892369

Last Updated: 2021-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Abuse or Dependence

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Alcohol FGF21 Alcohol dependence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ethanol

Ethanol administration

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Filip Krag Knop

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Filip K Knop, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-18063495

Identifier Type: -

Identifier Source: org_study_id