Prospective, Longitudinal Study on FItness DOping in DenmarK

NCT05599438 · tracked via the Priya Life Science Denmark tracker

Sponsor

Caroline Michaela Kistorp

Phase

Observational

Started

2022-06-14

Last updated

2024-02-15

Condition(s) studied

Anabolic Steroid OverdoseInfertilityCardiovascular ComplicationIllicit Drug UseFitnessMental Health Issue

Investigational drug(s) / intervention(s)

No intervention

No intervention: No intervention

Study summary

The aim of this prospective longitudinal study is to investigate the risks associated with use of anabolic steroids in fitness circles in Denmark in order to assess the scope of therapeutic need existing as a consequence of use. The objectives are:

* To assess long-term complications and outcomes related to: cardiovascular disease, diabetes, gonadal disease (women and men) and psychiatric disease using data from Danish registries including addressing central questions such as whether the following characteristics play a role for development of overt disease
* Characterization of illicit AAS use among men and women
* Current male reproductive health
* Current psychological well-being, aggressive tendencies, cognitive function and quality of life
* Current cardiovascular and metabolic status

The participants will undergo:

* Semi-structured medical interview
* Physical examinations
* Questionnaires
* Blood and urine sampling
* Dual X-ray Absorptiometry

With a subset undergoing further testing, including semen analysis, gonadotropin-releasing hormone (GnRH) and human chorionic gonadotropinm (hCG) stimulation and 82Rubidium positron emission tomography and computer tomography (PET/CT).

Register-based follow-up is planned every third year until the 15th year, marking the completion of the trial.

The study will include 800 participants with current or former AAS use and 100 participants (80 male; 20 female) as controls with no former or current use of AAS.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: \- Male and female recreational athletes (≥18 years of age) with current or former illicit use (\>3 months since AAS cessation) of PIEDs (e.g. AAS) for a minimum four weeks Inclusion Criteria (Controls, n = 100): \- Male (n=80) or female (n=20) recreational athletes (≥18 years of age) with NO current or former illicit use of AAS. Exclusion Criteria: * Severe psychiatric or somatic diseases which makes it impossible to give informed consent or comply with the investigatory program. * Known pregnancy.

Primary outcome measure(s)

Cardiovascular composite endpoint — 15 years
Register-based composite of mortality, stroke, myocardial infarction, hospitalization due to heart failure and significant cardiovascular disease (See protocol)

Trial sites (1)

Facility	City	Region	Status
Rigshospitalet	Copenhagen	Denmark	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05599438 on ClinicalTrials.gov ↗ ← All trials in Denmark