Prospective, Longitudinal Study of 800 Recreational Athletes With Current and Former Use of Performance and Image Enhancing Drugs (PIED), Focusing on Androgenic Anabolic Steroids (AAS) - Rigshospitalet

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• \- 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

• \- Male (n=80) or female (n=20) recreational athletes (≥18 years of age) with NO current or former illicit use of AAS.

Locations
Other Locations
Denmark
Rigshospitalet
RECRUITING
Copenhagen
Contact Information
Primary
Caroline M Kistorp, Professor
caroline.michaela.kistorp@regionh.dk
004535459642
Backup
Yeliz Bulut, MD
yeliz.bulut@regionh.dk
004535458079
Time Frame
Start Date: 2022-06-14
Estimated Completion Date: 2040-06-01
Participants
Target number of participants: 900
Treatments
Current users anabolic steroids
Current users of anabolic steroids with a use of more than 4 weeks
Former users of anabolic steroids
Former users of anabolic steroids with a use of more than 4 weeks
Healthy controls
100 participants with no former use of anabolic steroids~* 80 Male~* 20 Female
Related Therapeutic Areas
Sponsors
Leads: Caroline Michaela Kistorp
Collaborators: Centre for Preventative Doping Research at the German Sport University Cologne, Germany, Body Identity Clinic, Odense, Denmark, Copenhagen University Hospital at Herlev, Copenhagen University Hospital - Bispebjerg and Frederikssberg, Copenhagen, Denmark

This content was sourced from clinicaltrials.gov