Clinical trial NCT05178537: Cross-sectional Study of 1200 Recreational Athletes With Former or Current Use of Androgenic Anabolic Steroids
Official title: Cross-sectional Study of 1200 Recreational Athletes With Former or Current Use of Performance and Image Enhancing Drugs, Focusing on Androgenic Anabolic Steroid
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Morbidity
Androgen Deficiency
Heart Failure
Keywords: cardiovascular morbidity
doping
anabolic steroids
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recreational athletes (≥18 years of age) with current or former use of PIEDs, including AAS for ≥ 3 months

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Ultrasound aorta
timeFrame: 1 day (Only one timepoint as the study is cross sectional)
measure: Ultrasound of the carotid arteries and the femoral arteries
timeFrame: 1 day (Only one timepoint as the study is cross sectional)
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Jan Frystyk
Study officials:
affiliation: Odense University Hospital
name: Jan Frystyk
role: PRINCIPAL_INVESTIGATOR
References: