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Cross-sectional Study of 1200 Recreational Athletes With Former or Current Use of Androgenic Anabolic Steroids

Cross-sectional Study of 1200 Recreational Athletes With Former or Current Use of Performance and Image Enhancing Drugs, Focusing on Androgenic Anabolic Steroid

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05178537
Acronym
FIDODK/BIC
Enrollment
1200
Registered
2022-01-05
Start date
2022-01-01
Completion date
2025-12-01
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgen Deficiency, Cardiovascular Morbidity, Heart Failure

Keywords

cardiovascular morbidity, doping, anabolic steroids

Brief summary

Overarching aim of project Performance and image enhancing drugs (PIEDs) are pharmacological agents acquired illicitly to improve physical strength and endurance as well as to obtain a leaner and more muscular appearance. Androgenic anabolic steroids (AAS) are the most frequently used PIED and include testosterone and its synthetic derivatives. However, PIEDs also include other hormones, e.g. growth hormone (GH), insulin-like growth factor I (IGF-I), glucocorticoids, insulin and thyroxin. Originally, the use of PIEDs was predominately restricted to elite athletes. However, today most users of PIEDs are recreational athletes. In USA, the prevalence of recreational PIED users (three million) exceeds the prevalence of type 1 diabetes. This appears to be the same in Denmark, where the estimated prevalence of recreational users of PIEDs is 44,000, compared to approximately 30,000 patients with type 1 diabetes. The access to AAS is easy due to the unregulated and illicit sale on the internet. Furthermore, PIED use is common in the young population with possible detrimental effects on future health and well-being. PIEDs are linked to premature death and a wide spectrum of somatic and psychological disorders. However, clinical data on the use of PIEDs is currently limited. Randomized trials of PIEDs are unethical as this would require administration of potentially harmful supra-physiological doses of hormones and this is the rationale behind our proposal to perform an observational study. With this project the investigators propose to a) Perform a cross-sectional nationwide study of current and former users of PIEDs (N=1200), focusing on AAS. In particular, the investigators will pay attention to: 1. Preclinical cardiovascular disease 2. Psychological well-being, aggression and quality of life 3. Biomarkers of ageing 4. Body composition and muscle strength b) Establish a nationwide biobank containing blood, urine and hair samples from current and former users of PIEDs.

Detailed description

Performance and image enhancing drugs (PIEDs) are pharmacological agents acquired illicitly to improve physical strength and endurance as well as to obtain a leaner and more muscular appearance. Androgenic anabolic steroids (AAS) are the most frequently used PIED and include testosterone and its synthetic derivatives. However, PIEDs also include other hormones, e.g. growth hormone (GH), insulin-like growth factor I (IGF-I), glucocorticoids, insulin and thyroxin. Originally, the use of PIEDs was predominately restricted to elite athletes. However, today most users of PIEDs are recreational athletes. In USA, the prevalence of recreational PIED users (three million) exceeds the prevalence of type 1 diabetes. This appears to be the same in Denmark, where the estimated prevalence of recreational users of PIEDs is 44,000, compared to approximately 30,000 patients with type 1 diabetes. The access to AAS is easy due to the unregulated and illicit sale on the internet. Furthermore, PIED use is common in the young population with possible detrimental effects on future health and well-being. PIEDs are linked to premature death and a wide spectrum of somatic and psychological disorders. However, clinical data on the use of PIEDs is currently limited. Randomized trials of PIEDs are unethical as this would require administration of potentially harmful supra-physiological doses of hormones and this is the rationale behind our proposal to perform an observational study. With this project the investigators propose to a) Perform a cross-sectional nationwide study of current and former users of PIEDs (N=1200), focusing on AAS. In particular, the investigators will pay attention to: 1. Preclinical cardiovascular disease 2. Psychological well-being, aggression and quality of life 3. Biomarkers of ageing 4. Body composition and muscle strength b) Establish a nationwide biobank containing blood, urine and hair samples from current and former users of PIEDs. Study population Inclusion criteria • Recreational athletes (≥18 years of age) with current or former use of PIEDs, including AAS for ≥ 3 months Exclusion criteria • Severe psychiatric or somatic diseases which makes it impossible to give informed consent or comply with the investigatory program Estimated number of participants over 3 years are N=1200. Participants are recruited using social media groups, newspapers, posters in fitness centers and at general practitioners. Recruitment is performed in collaboration with Anti Doping Denmark. Investigations Patient reported outcomes (PRO) Bio impedance Muscle strength measurement Clinical examination Medical history and socioeconomic status Blood and urine samples Ultrasound of the carotid artery and aorta Echocardiography and ECG CHANGE IN PRIMARY ENDPOINT Amendment - modification of the description of the primary end-point: January 16, 2024. This clinical study is descriptive: It aims to describe the cardiovascular and mental health status of recreational athletes using anabolic androgenic steroids. As such, no strict statistical power calculations were performed. Originally, the primary endpoint was ultrasound-detected calcifications of aorta using a 3.5 mHz transducer. However, due to body size of the anabolic androgenic steroid using participants, the results have appeared not to be reliable. This became evident after the pilot study, which has included 120 recreational athletes. Consequently, the primary endpoint was modified to ultrasound-determined plaques of the carotid and the femoral arteries; i.e. North and South of the abdominal aorta.

Interventions

OTHERAAS users

no intervention

Sponsors

Jan Frystyk
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Recreational athletes (≥18 years of age) with current or former use of PIEDs, including AAS for ≥ 3 months

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Ultrasound aorta1 day (Only one timepoint as the study is cross sectional)calcifications
Ultrasound of the carotid arteries and the femoral arteries1 day (Only one timepoint as the study is cross sectional)calcifications

Countries

Denmark

Contacts

Primary ContactJan Frystyk, Professor
jan.frystyk@rsyd.dk65411807
Backup ContactLaust Buhl, MD
65411807

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026