Prospective, Longitudinal Study on FItness DOping in DenmarK

NCT05599438 | Recruiting DMC

• 1 other identifier: H-21035759
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cardiovascular Disease; Metabolic syndrome; Infertility; Mortality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Fertility-related composite endpoint

  15 years

• Metabolism-related composite endpoint

  15 years

• Mental health-related composite endpoint

  15 years

• Male fertility

  Baseline comparison when substudy is completed (expected 2023)

• Myocardial flow reserve

  Baseline comparison when substudy is completed (expected 2023)

Other Outcomes (4)

• Anthropometry of the body composition of current and former users of AAS

  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

  Baseline comparison on entire cohort when initial completion is achieved (Date of primary completion)

• Extensive clinical characterization of current and former users of AAS

  Baseline comparison on entire cohort when initial completion is achieved (Date of primary completion)

Study Arms (3)

Current users anabolic steroids

Current users of anabolic steroids with a use of more than 4 weeks

Other: No intervention

Former users of anabolic steroids

Former users of anabolic steroids with a use of more than 4 weeks

Other: No intervention

Healthy controls

100 participants with no former use of anabolic steroids * 80 Male * 20 Female

Other: No intervention

Interventions

No intervention OTHER

No intervention

Current users anabolic steroids; Former users of anabolic steroids; Healthy controls

Eligibility Criteria

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

You may qualify if:

• \- 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.

You may not qualify if:

• Severe psychiatric or somatic diseases which makes it impossible to give informed consent or comply with the investigatory program.
• Known pregnancy.

Sponsors & Collaborators

• Caroline Michaela Kistorp: lead
• Copenhagen University Hospital at Herlev: collaborator
• University Hospital Bispebjerg and Frederiksberg: collaborator
• Centre for Preventative Doping Research at the German Sport University Cologne, Germany: collaborator
• Body Identity Clinic, Odense, Denmark: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Research biobank containing blood and urine

MeSH Terms

Conditions

Infertility; Cardiovascular Diseases; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Caroline M Kistorp, Professor

  Centre for Cancer and Organ Disease, Department for Medical Endocrinology, Rigshospitalet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline M Kistorp, Professor

CONTACT

004535459642; caroline.michaela.kistorp@regionh.dk

Yeliz Bulut, MD

CONTACT

004535458079; yeliz.bulut@regionh.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 31, 2022
• Study Start: June 14, 2022
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2040
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)