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| Name | Class |
|---|---|
| Copenhagen University Hospital at Herlev | OTHER |
| University Hospital Bispebjerg and Frederiksberg | OTHER |
| German Sport University, Cologne | OTHER |
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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:
The participants will undergo:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| 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 |
| 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) |
| 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 |
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:
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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)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline M Kistorp, Professor | Contact | 004535459642 | caroline.michaela.kistorp@regionh.dk | |
| Yeliz Bulut, MD | Contact | 004535458079 | yeliz.bulut@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Caroline M Kistorp, Professor | Centre for Cancer and Organ Disease, Department for Medical Endocrinology, Rigshospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
Due to national judicial restrictions individual participant data cannot be shared.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 30, 2022 | Oct 25, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D002318 | Cardiovascular Diseases |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
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| Body Identity Clinic, Odense, Denmark |
| UNKNOWN |
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Research biobank containing blood and urine
| 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) |
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) |
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |