Alcohol Abuse or DependenceAlcoDepNCT03892369
FGF21 and Its Role in Alcohol Dependence
A study testing Ethanol in people with Alcohol Abuse or Dependence, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse or Dependence
- What is being tested?
- Ethanol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2019to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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):
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- 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
Who cannot join
- 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):
Show all 10Show fewer
- Former alcohol dependence or abuse
- Healthy participants (group C):
- First-degree relatives with diabetes, liver disease and/or alcohol dependence
- Former alcohol dependence
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, 2900
About this study
Official title: 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.
- Conditions
- Alcohol Abuse or Dependence
- Being tested
- Ethanol
- Keywords
- Alcohol, FGF21, Alcohol dependence
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EthanolOther
Ethanol administration
| Study group | Role | What they receive |
|---|---|---|
| Alcohol | Experimental | The participant receive 0.5 g ethanol per kg body weight over 10 minutes. Subsequently blood samples are taken frequently the next ten hours. Receives: Other: Ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibroblast growthfactor-21
Plasma FGF21 concentrations, a member of the endocrine FGF-family
Measured: One year
Secondary outcomes (10)
Ethanol
Plasma ethanol concentration
Measured: One year
Glucose
Plasma glucose concentrations
Measured: One year
Insulin and C-peptide
Serum insulin and C-peptide concentrations
Measured: One year
Glucagon
Plasma glucagon concentration
Measured: One year
Tumor Necrosis Factor-alpha (TNF)
Plasma TNF-alpha concentrations
Measured: One year
Lipopolysaccharide Binding Protein (LBP)
Plasma LBP concentrations
Measured: One year
Interferon-gamma (INF)
Plasma INF-gamma concentrations
Measured: One year
Interleukine-10 (IL-10)
Plasma IL-10 concentrations
Measured: One year
Interleukine-8 (IL-8)
Plasma IL-8 concentrations
Measured: One year
Interleukine-6 (IL-6)
Plasma IL-6 concentrations
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Sep 2019
- Primary completion1 Jun 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Abuse or DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Krag Knop, University Hospital, Gentofte, Copenhagen
- Investigators
- Filip K Knop, MD, Principal investigator, Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892369
- Sponsor's protocol ID
- H-18063495
- Acronym
- AlcoDep
- Status last verified
- Dec 2021
- First submitted
- 22 Mar 2019
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects of FGF21 in Humans and Its Pathophysiological Role in Alcohol Dependence
- ClinicalTrials.gov ID
- NCT03892369
- Acronym / sponsor ID
- AlcoDep / H-18063495
- Conditions
- Alcohol Abuse or Dependence
- Keywords
- Alcohol, FGF21, Alcohol dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Alcohol | Experimental | Other: EthanolThe participant receive 0.5 g ethanol per kg body weight over 10 minutes. Subsequently blood samples are taken frequently the next ten hours. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EthanolEthanol administration | Other | Alcohol |
Primary outcome
Fibroblast growthfactor-21
Time frame: One year
Plasma FGF21 concentrations, a member of the endocrine FGF-family
10 secondary outcomes
Ethanol
Time frame: One year
Glucose
Time frame: One year
Insulin and C-peptide
Time frame: One year
Glucagon
Time frame: One year
Tumor Necrosis Factor-alpha (TNF)
Time frame: One year
Lipopolysaccharide Binding Protein (LBP)
Time frame: One year
Interferon-gamma (INF)
Time frame: One year
Interleukine-10 (IL-10)
Time frame: One year
Interleukine-8 (IL-8)
Time frame: One year
Interleukine-6 (IL-6)
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip K Knop, MD principal investigator
Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethanol in people with Alcohol Abuse or Dependence, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibroblast growthfactor-21 (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.