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NCT Number: NCT05599438

Prospective, Longitudinal Study on FItness DOping in DenmarK

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Cardiovascular composite endpoint

    Time frame: 15 years

    Register-based composite of mortality, stroke, myocardial infarction, hospitalization due to heart failure and significant cardiovascular disease (See protocol)

Secondary outcomes

  1. Fertility-related composite endpoint

    Time frame: 15 years

    Register-based composite of diagnoses related to fertility and testicular/ovarian function

  2. Metabolism-related composite endpoint

    Time frame: 15 years

    Register-based composite of diagnosis related to impaired metabolic function (See protocol)

  3. Mental health-related composite endpoint

    Time frame: 15 years

    Register-based composite of diagnosis related to psychiatric diagnosis (See protocol)

  4. Male fertility

    Time frame: Baseline comparison when substudy is completed (expected 2023)

    Substudy analysis on difference in motile sperm count between groups (n=280 male participants; [current/former/controls] 60/60/80)

  5. Myocardial flow reserve

    Time frame: Baseline comparison when substudy is completed (expected 2023)

    Substudy analysis on differences in myocardial flow reserve across groups (n=150 participants; male [current/former/controls]: 30/30/30; female [current/former/current]: 20/20/20)

  6. hCG stimulation test

    Time frame: Baseline comparison when substudy is completed (expected 2023)

    Substudy analysis on difference in response to hCG stimulation test (n=60 male participants [former/controls]: 30/30)

Other outcomes

  1. Anthropometry of the body composition of current and former users of AAS

    Time frame: Baseline comparison on entire cohort when initial completion is achieved (Date of primary completion)

    Analysis on group-differences in lean and fat mass evaluated by Dual X-ray Absorptiometry

  2. Extensive examination of the mental health of current and former users of AAS using questionnaires

    Time frame: Baseline comparison on entire cohort when initial completion is achieved (Date of primary completion)

    Analysis on group-differences in response to questionnaires between current, former users of AAS and healthy controls (Questionnaires and further description found in protocol)

  3. Extensive clinical characterization of current and former users of AAS

    Time frame: Baseline comparison on entire cohort when initial completion is achieved (Date of primary completion)

    Analysis on group-differences in clinical characteristics between current, former users of AAS and healthy controls (Measures and further description found in protocol)

  4. Extensive biochemical profile of current and former users of AAS

    Time frame: Baseline comparison on entire cohort when initial completion is achieved (Date of primary completion)

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline M Kistorp, Professor

CONTACT

[email protected]

004535459642

Yeliz Bulut, MD

CONTACT

[email protected]

004535458079

Sponsors and collaborators

Lead sponsor

Caroline Michaela Kistorp

Other

Collaborators

  • Body Identity Clinic, Odense, Denmark
  • Copenhagen University Hospital at Herlev
  • German Sport University, Cologne
  • University Hospital Bispebjerg and Frederiksberg

Registry information

Official study 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

Acronym: FIDO-DK/RH

Important dates

Study start
2022
Primary completion
2025
Study completion
2040
First posted
Oct 31, 2022
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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