Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05178537 |
| Other study ID # |
BICAAS01 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
December 1, 2025 |
Study information
| Verified date |
January 2024 |
| Source |
Odense University Hospital |
| Contact |
Jan Frystyk, Professor |
| Phone |
65411807 |
| Email |
jan.frystyk[@]rsyd.dk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
