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临床试验/NCT05599438
NCT05599438招募中不适用

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

Caroline Michaela Kistorp1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2022年6月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
900
试验地点
1
主要终点
Cardiovascular composite endpoint

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Cardiovascular composite endpoint

时间窗: 15 years

Register-based composite of mortality, stroke, myocardial infarction, hospitalization due to heart failure and significant cardiovascular disease (See protocol)

次要结局

  • Metabolism-related composite endpoint(15 years)
  • Fertility-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))
  • hCG stimulation test(Baseline comparison when substudy is completed (expected 2023))
  • Mental health-related composite endpoint(15 years)

研究者

发起方
Caroline Michaela Kistorp
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Caroline Michaela Kistorp

Professor

Rigshospitalet, Denmark

研究点 (1)

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