- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05178537
Cross-sectional Study of 1200 Recreational Athletes With Former or Current Use of Androgenic Anabolic Steroids (FIDODK/BIC)
Cross-sectional Study of 1200 Recreational Athletes With Former or Current Use of Performance and Image Enhancing Drugs, Focusing on Androgenic Anabolic Steroid
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:
- Preclinical cardiovascular disease
- Psychological well-being, aggression and quality of life
- Biomarkers of ageing
- Body composition and muscle strength b) Establish a nationwide biobank containing blood, urine and hair samples from current and former users of PIEDs.
Study Overview
Status
Intervention / Treatment
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:
- Preclinical cardiovascular disease
- Psychological well-being, aggression and quality of life
- Biomarkers of ageing
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jan Frystyk, Professor
- Phone Number: 0045 65411807
- Email: jan.frystyk@rsyd.dk
Study Contact Backup
- Name: Laust Buhl, MD
- Phone Number: 0045 65411807
Study Locations
-
-
-
Odense, Denmark, 5000
- Recruiting
- Jan Frystyk
-
Contact:
- laust buhl frisenberg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Recreational athletes (≥18 years of age) with current or former use of PIEDs, including AAS for ≥ 3 months
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
AAS users
current og previous use of AAS
|
no intervention
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ultrasound aorta
Time Frame: 1 day (Only one timepoint as the study is cross sectional)
|
calcifications
|
1 day (Only one timepoint as the study is cross sectional)
|
Ultrasound of the carotid arteries and the femoral arteries
Time Frame: 1 day (Only one timepoint as the study is cross sectional)
|
calcifications
|
1 day (Only one timepoint as the study is cross sectional)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jan Frystyk, Odense University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BICAAS01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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