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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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05178537
Study type Observational
Source Odense University Hospital
Contact Jan Frystyk, Professor
Phone 65411807
Email [email protected]
Status Not yet recruiting
Phase
Start date January 1, 2022
Completion date December 1, 2025

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