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临床试验/NCT05178537
NCT05178537招募中不适用

Cross-sectional Study of 1200 Recreational Athletes With Former or Current Use of Performance and Image Enhancing Drugs, Focusing on Androgenic Anabolic Steroid

Jan Frystyk1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2022年1月1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
1,200
试验地点
1
主要终点
Ultrasound of the carotid arteries and the femoral arteries

研究概览

简要总结

Overarching aim of project Performance and image enhancing drugs (PIEDs) are pharmacological agents acquired illicitly to improve physical strength and endurance as well as to obtain a leaner and more muscular appearance. Androgenic anabolic steroids (AAS) are the most frequently used PIED and include testosterone and its synthetic derivatives. However, PIEDs also include other hormones, e.g. growth hormone (GH), insulin-like growth factor I (IGF-I), glucocorticoids, insulin and thyroxin.

Originally, the use of PIEDs was predominately restricted to elite athletes. However, today most users of PIEDs are recreational athletes. In USA, the prevalence of recreational PIED users (three million) exceeds the prevalence of type 1 diabetes. This appears to be the same in Denmark, where the estimated prevalence of recreational users of PIEDs is 44,000, compared to approximately 30,000 patients with type 1 diabetes. The access to AAS is easy due to the unregulated and illicit sale on the internet. Furthermore, PIED use is common in the young population with possible detrimental effects on future health and well-being.

PIEDs are linked to premature death and a wide spectrum of somatic and psychological disorders. However, clinical data on the use of PIEDs is currently limited. Randomized trials of PIEDs are unethical as this would require administration of potentially harmful supra-physiological doses of hormones and this is the rationale behind our proposal to perform an observational study.

With this project the investigators propose to

a) Perform a cross-sectional nationwide study of current and former users of PIEDs (N=1200), focusing on AAS. In particular, the investigators will pay attention to:

  1. Preclinical cardiovascular disease
  2. Psychological well-being, aggression and quality of life
  3. Biomarkers of ageing
  4. Body composition and muscle strength b) Establish a nationwide biobank containing blood, urine and hair samples from current and former users of PIEDs.

详细描述

Performance and image enhancing drugs (PIEDs) are pharmacological agents acquired illicitly to improve physical strength and endurance as well as to obtain a leaner and more muscular appearance. Androgenic anabolic steroids (AAS) are the most frequently used PIED and include testosterone and its synthetic derivatives. However, PIEDs also include other hormones, e.g. growth hormone (GH), insulin-like growth factor I (IGF-I), glucocorticoids, insulin and thyroxin.

Originally, the use of PIEDs was predominately restricted to elite athletes. However, today most users of PIEDs are recreational athletes. In USA, the prevalence of recreational PIED users (three million) exceeds the prevalence of type 1 diabetes. This appears to be the same in Denmark, where the estimated prevalence of recreational users of PIEDs is 44,000, compared to approximately 30,000 patients with type 1 diabetes. The access to AAS is easy due to the unregulated and illicit sale on the internet. Furthermore, PIED use is common in the young population with possible detrimental effects on future health and well-being.

PIEDs are linked to premature death and a wide spectrum of somatic and psychological disorders. However, clinical data on the use of PIEDs is currently limited. Randomized trials of PIEDs are unethical as this would require administration of potentially harmful supra-physiological doses of hormones and this is the rationale behind our proposal to perform an observational study.

With this project the investigators propose to

a) Perform a cross-sectional nationwide study of current and former users of PIEDs (N=1200), focusing on AAS. In particular, the investigators will pay attention to:

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Recreational athletes (≥18 years of age) with current or former use of PIEDs, including AAS for ≥ 3 months

排除标准

  • 未提供

结局指标

主要结局

Ultrasound of the carotid arteries and the femoral arteries

时间窗: 1 day (Only one timepoint as the study is cross sectional)

calcifications

Ultrasound aorta

时间窗: 1 day (Only one timepoint as the study is cross sectional)

calcifications

次要结局

未报告次要终点

研究者

发起方
Jan Frystyk
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jan Frystyk

Clinical professor

Odense University Hospital

研究点 (1)

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