The aim of this prospective longitudinal study is to investigate the risks associated with use of anabolic steroids in fitness circles in Denmark in order to assess the scope of therapeutic need existing as a consequence of use. The objectives are:
* To assess long-term complications and outcomes related to: cardiovascular disease, diabetes, gonadal disease (women and men) and psychiatric disease using data from Danish registries including addressing central questions such as whether the following characteristics play a role for development of overt disease * Characterization of illicit AAS use among men and women * Current male reproductive health * Current psychological well-being, aggressive tendencies, cognitive function and quality of life * Current cardiovascular and metabolic status
The participants will undergo:
* Semi-structured medical interview * Physical examinations * Questionnaires * Blood and urine sampling * Dual X-ray Absorptiometry
With a subset undergoing further testing, including semen analysis, gonadotropin-releasing hormone (GnRH) and human chorionic gonadotropinm (hCG) stimulation and 82Rubidium positron emission tomography and computer tomography (PET/CT).
Register-based follow-up is planned every third year until the 15th year, marking the completion of the trial.
The study will include 800 participants with current or former AAS use and 100 participants (80 male; 20 female) as controls with no former or current use of AAS.
None
Severe psychiatric or somatic diseases which makes it impossible to give informed consent or comply with the investigatory program.
Known pregnancy.
Participants with current or former use of anabolic steroids of both male and female sex. The study also includes a control group (n=100 \[male/female\] - 80/20)
Case-control
Prospective
No intervention
Other interventionNo intervention
Cardiovascular composite endpoint
Register-based composite of mortality, stroke, myocardial infarction, hospitalization due to heart failure and significant cardiovascular disease (See protocol)
Fertility-related composite endpoint
Register-based composite of diagnoses related to fertility and testicular/ovarian function
Metabolism-related composite endpoint
Register-based composite of diagnosis related to impaired metabolic function (See protocol)
Mental health-related composite endpoint
Register-based composite of diagnosis related to psychiatric diagnosis (See protocol)
Male fertility
Substudy analysis on difference in motile sperm count between groups (n=280 male participants; \[current/former/controls\] 60/60/80)
Anthropometry of the body composition of current and former users of AAS
Analysis on group-differences in lean and fat mass evaluated by Dual X-ray Absorptiometry
Extensive examination of the mental health of current and former users of AAS using questionnaires
Analysis on group-differences in response to questionnaires between current, former users of AAS and healthy controls (Questionnaires and further description found in protocol)
Extensive clinical characterization of current and former users of AAS
Analysis on group-differences in clinical characteristics between current, former users of AAS and healthy controls (Measures and further description found in protocol)
Extensive biochemical profile of current and former users of AAS
Analysis on group-differences in biochemical measures in blood and urine between current, former users of AAS and healthy controls (Measures and further description found in protocol)
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Caroline Michaela Kistorp
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Copenhagen University Hospital at Herlev
Collaborator
University Hospital Bispebjerg and Frederiksberg
Collaborator
German Sport University, Cologne
Collaborator
Body Identity Clinic, Odense, Denmark
Collaborator
