Prospective, Longitudinal Study on FItness DOping in DenmarK

NCT05599438 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 900

Last updated 2024-02-15

No results posted yet for this 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.

Conditions

  • Anabolic Steroid Overdose
  • Infertility
  • Cardiovascular Complication
  • Illicit Drug Use
  • Fitness
  • Mental Health Issue

Interventions

OTHER

No intervention

No intervention

Sponsors & Collaborators

  • Copenhagen University Hospital at Herlev

    collaborator OTHER
  • Copenhagen University Hospital - Bispebjerg and Frederikssberg, Copenhagen, Denmark

    collaborator UNKNOWN
  • Centre for Preventative Doping Research at the German Sport University Cologne, Germany

    collaborator UNKNOWN
  • Body Identity Clinic, Odense, Denmark

    collaborator UNKNOWN
  • Caroline Michaela Kistorp

    lead OTHER

Principal Investigators

  • Caroline M Kistorp, Professor · Centre for Cancer and Organ Disease, Department for Medical Endocrinology, Rigshospitalet

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-14
Primary Completion
2025-06-01
Completion
2040-06-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05599438 on ClinicalTrials.gov