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

NCT05178537 | Unknown

• 1 other identifier: BICAAS01
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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. 1.Preclinical cardiovascular disease
2. 2.Psychological well-being, aggression and quality of life
3. 3.Biomarkers of ageing
4. 4.Body composition and muscle strength b) Establish a nationwide biobank containing blood, urine and hair samples from current and former users of PIEDs.

Conditions

Cardiovascular Morbidity; Androgen Deficiency; Heart Failure

Keywords

cardiovascular morbidity; doping; anabolic steroids

Outcome Measures

Primary Outcomes (2)

• Ultrasound aorta

  calcifications

  1 day (Only one timepoint as the study is cross sectional)

• Ultrasound of the carotid arteries and the femoral arteries

  calcifications

  1 day (Only one timepoint as the study is cross sectional)

Study Arms (1)

AAS users

current og previous use of AAS

Other: AAS users

Interventions

AAS users OTHER

no intervention

Also known as: no intervention

AAS users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Jan Frystyk: lead

Study Sites (1)

Jan Frystyk

Odense, 5000, Denmark

RECRUITING

Related Publications (1)

• Buhl LF, Lehmann Christensen L, Diederichsen A, Lindholt JS, Kistorp CM, Glintborg D, Andersen M, Frystyk J. Impact of androgenic anabolic steroid use on cardiovascular and mental health in Danish recreational athletes: protocol for a nationwide cross-sectional cohort study as a part of the Fitness Doping in Denmark (FIDO-DK) study. BMJ Open. 2024 May 7;14(5):e078558. doi: 10.1136/bmjopen-2023-078558.

  PMID: 38719280 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jan Frystyk

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Frystyk, Professor

CONTACT

65411807; jan.frystyk@rsyd.dk

Laust Buhl, MD

CONTACT

65411807

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 5, 2022
• Study Start: January 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 22, 2024

Record last verified: 2024-01

Locations

DK (1)