Prospective, Longitudinal Study on FItness DOping in DenmarK (FIDO-DK/RH)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility; Mental Health Issue; Fitness; Cardiovascular Complication; Anabolic Steroid Overdose; Illicit Drug Use
• Intervention / Treatment: Other: No intervention

Detailed Description

Anabolic steroids (AAS) are synthetic derivates of the male sexhormone testosterone. The use of AAS is a growing phenomenon and have extended beyond the elite performance and body builder communities, involving a broader populace. The continued use causes a long-term impairment of testicular function, with symptoms of including impotence, depression, infertility and an increased risk of cardiovascular disease. AAS use is a clinical challenge as many psychological symptoms worsen in case of cessation of use. As AAS is often used by young individuals, the fulminant disease is rarely found by incidental screening. To assess long-term consequences, a large cohort is in need to be studied to accurately identify the risk of disease and when to initiate treatment. Furthermore, despite the use of AAS in women is present, the scientific community has thus far not taken notice, and the consequences are unknown, but are presumed to - beyond the changes in physical appearance - to include changes in fertility, risk of type 2 diabetes and cardiovascular disease. As AAS is acquired illicitly, the knowledge on the consequences of AAS use is sparse. No international or national consensus or recommendations exist as to the how to stop AAS use, screening of disease or therapeutic option in case of manifestations of symptoms or fulminant disease. The aim of the current study is to elucidate on the consequences of use of AAS in fitness circles in Denmark to assess the scope of therapeutic need.

• Study Type: Observational
• Enrollment (Estimated): 900

Contacts and Locations

• Study Contact: Name: Caroline M Kistorp, Professor; Phone Number: 004535459642; Email: caroline.michaela.kistorp@regionh.dk
• Study Contact Backup: Name: Yeliz Bulut, MD; Phone Number: 004535458079; Email: yeliz.bulut@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Rigshospitalet
    • Contact: Yeliz Bulut, MD; Phone Number: 004535458079; Email: yeliz.bulut@regionh.dk
    • Contact: Caroline Kistorp, Professor; Phone Number: 004535459642; Email: caroline.michaela.kistorp@regionh.dk
    • Sub-Investigator: Niels Høeg Brandt-Jacobsen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants with current or former use of anabolic steroids of both male and female sex. The study also includes a control group (n=100 [male/female] - 80/20)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Current users anabolic steroids; Current users of anabolic steroids with a use of more than 4 weeks	Other: No intervention; No intervention
Former users of anabolic steroids; Former users of anabolic steroids with a use of more than 4 weeks	Other: No intervention; No intervention
Healthy controls; 100 participants with no former use of anabolic steroids; 80 Male; 20 Female	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fertility-related composite endpoint	Register-based composite of diagnoses related to fertility and testicular/ovarian function	15 years
Metabolism-related composite endpoint	Register-based composite of diagnosis related to impaired metabolic function (See protocol)	15 years
Mental health-related composite endpoint	Register-based composite of diagnosis related to psychiatric diagnosis (See protocol)	15 years
Male fertility	Substudy analysis on difference in motile sperm count between groups (n=280 male participants; [current/former/controls] 60/60/80)	Baseline comparison when substudy is completed (expected 2023)
Myocardial flow reserve	Substudy analysis on differences in myocardial flow reserve across groups (n=150 participants; male [current/former/controls]: 30/30/30; female [current/former/current]: 20/20/20)	Baseline comparison when substudy is completed (expected 2023)
hCG stimulation test	Substudy analysis on difference in response to hCG stimulation test (n=60 male participants [former/controls]: 30/30)	Baseline comparison when substudy is completed (expected 2023)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometry of the body composition of current and former users of AAS	Analysis on group-differences in lean and fat mass evaluated by Dual X-ray Absorptiometry	Baseline comparison on entire cohort when initial completion is achieved (Date of primary completion)
Extensive examination of the mental health of current and former users of AAS using questionnaires	Analysis on group-differences in response to questionnaires between current, former users of AAS and healthy controls (Questionnaires and further description found in protocol)	Baseline comparison on entire cohort when initial completion is achieved (Date of primary completion)
Extensive clinical characterization of current and former users of AAS	Analysis on group-differences in clinical characteristics between current, former users of AAS and healthy controls (Measures and further description found in protocol)	Baseline comparison on entire cohort when initial completion is achieved (Date of primary completion)
Extensive biochemical profile of current and former users of AAS	Analysis on group-differences in biochemical measures in blood and urine between current, former users of AAS and healthy controls (Measures and further description found in protocol)	Baseline comparison on entire cohort when initial completion is achieved (Date of primary completion)

Collaborators and Investigators

• Sponsor: Caroline Michaela Kistorp
• Collaborators: Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark; Copenhagen University Hospital - Bispebjerg and Frederikssberg, Copenhagen, Denmark; Centre for Preventative Doping Research at the German Sport University Cologne, Germany; Body Identity Clinic, Odense, Denmark
• Investigators: Principal Investigator: Caroline M Kistorp, Professor, Centre for Cancer and Organ Disease, Department for Medical Endocrinology, Rigshospitalet

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2040

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Metabolic syndrome; Infertility; Cardiovascular Disease; Mortality
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: H-21035759

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to national judicial restrictions individual participant data cannot be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No