Clinical trial NCT05599438: Prospective, Longitudinal Study on FItness DOping in DenmarK
Official title: Prospective, Longitudinal Study of 800 Recreational Athletes With Current and Former Use of Performance and Image Enhancing Drugs (PIED), Focusing on Androgenic Anabolic Steroids (AAS) - Rigshospitalet
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anabolic Steroid Overdose
Infertility
Cardiovascular Complication
Illicit Drug Use
Fitness
Mental Health Issue
Keywords: Cardiovascular Disease
Metabolic syndrome
Infertility
Mortality
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark
name: Copenhagen University Hospital - Bispebjerg and Frederikssberg, Copenhagen, Denmark
name: Centre for Preventative Doping Research at the German Sport University Cologne, Germany
name: Body Identity Clinic, Odense, Denmark
First posted: 2022-10-31
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

Brief summary: 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.

Detailed description: Anabolic steroids (AAS) are synthetic derivates of the male sexhormone testosterone. The use of AAS is a growing phenomenon and have extended beyond the elite performance and body builder communities, involving a broader populace. The continued use causes a long-term impairment of testicular function, with symptoms of including impotence, depression, infertility and an increased risk of cardiovascular disease. AAS use is a clinical challenge as many psychological symptoms worsen in case of cessation of use. As AAS is often used by young individuals, the fulminant disease is rarely found by incidental screening. To assess long-term consequences, a large cohort is in need to be studied to accurately identify the risk of disease and when to initiate treatment. Furthermore, despite the use of AAS in women is present, the scientific community has thus far not taken notice, and the consequences are unknown, but are presumed to - beyond the changes in physical appearance - to include changes in fertility, risk of type 2 diabetes and cardiovascular disease. As AAS is acquired illicitly, the knowledge on the consequences of AAS use is sparse. No international or national consensus or recommendations exist as to the how to stop AAS use, screening of disease or therapeutic option in case of manifestations of symptoms or fulminant disease. The aim of the current study is to elucidate on the consequences of use of AAS in fitness circles in Denmark to assess the scope of therapeutic need.

Eligibility criteria: Inclusion Criteria:

- Male and female recreational athletes (≥18 years of age) with current or former illicit use (\>3 months since AAS cessation) of PIEDs (e.g. AAS) for a minimum four weeks

Inclusion Criteria (Controls, n = 100):

- Male (n=80) or female (n=20) recreational athletes (≥18 years of age) with NO current or former illicit use of AAS.

Exclusion Criteria:

* Severe psychiatric or somatic diseases which makes it impossible to give informed consent or comply with the investigatory program.
* Known pregnancy.

Primary outcomes:
measure: Cardiovascular composite endpoint
timeFrame: 15 years
Secondary outcomes:
measure: Fertility-related composite endpoint
timeFrame: 15 years
measure: Metabolism-related composite endpoint
timeFrame: 15 years
measure: Mental health-related composite endpoint
timeFrame: 15 years
measure: Male fertility
timeFrame: Baseline comparison when substudy is completed (expected 2023)
measure: Myocardial flow reserve
timeFrame: Baseline comparison when substudy is completed (expected 2023)
measure: hCG stimulation test
timeFrame: Baseline comparison when substudy is completed (expected 2023)
Other outcomes:
measure: Anthropometry of the body composition of current and former users of AAS
timeFrame: Baseline comparison on entire cohort when initial completion is achieved (Date of primary completion)
measure: Extensive examination of the mental health of current and former users of AAS using questionnaires
timeFrame: Baseline comparison on entire cohort when initial completion is achieved (Date of primary completion)
measure: Extensive clinical characterization of current and former users of AAS
timeFrame: Baseline comparison on entire cohort when initial completion is achieved (Date of primary completion)
measure: Extensive biochemical profile of current and former users of AAS
timeFrame: Baseline comparison on entire cohort when initial completion is achieved (Date of primary completion)
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Centre for Cancer and Organ Disease, Department for Medical Endocrinology, Rigshospitalet
name: Caroline M Kistorp, Professor
role: PRINCIPAL_INVESTIGATOR
References: