Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-24 @ 11:09 PM
NCT ID:
NCT03892369
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
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT03892369
Study Brief:
Protocol Section:
NCT03892369