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Tesamorelin administration study: urinary detection

In force Project description Code: 23C07KD Tesamorelin is a synthetic growth hormone-releasing hormone (GHRH) analogue, used for the reduction of excess abdominal fat in HIV-infected adults. As a GHRH analogue, it triggers the secretion of growth hormone (GH), which in turn increases serum insulin-like growth factor 1 (IGF-1) levels. The latter exerts an anabolic (growth) effect on tissues throughout the human body. Since this anabolic effect is evidently beneficial for many athletes, the GHRH – GH –IGF-1 axis is a common target in sports doping. All three compounds, as well as their analogues, are banned by the World Anti-Doping Agency (WADA) at all times. Besides curating the list of prohibited compounds, WADA also provides doping control laboratories with a set of minimum required performance levels (MRPL) for these compounds. These MRPLs indicate the sensitivity that a detection method should achieve for a certain compound and are commonly based on administration studies. Since dop

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Study findings do not automatically establish clinical benefit, safety, dosing, or suitability for an individual.

In force

Project description

Code: 23C07KD

Tesamorelin is a synthetic growth hormone-releasing hormone (GHRH) analogue, used for the reduction of excess abdominal fat in HIV-infected adults. As a GHRH analogue, it triggers the secretion of growth hormone (GH), which in turn increases serum insulin-like growth factor 1 (IGF-1) levels. The latter exerts an anabolic (growth) effect on tissues throughout the human body. Since this anabolic effect is evidently beneficial for many athletes, the GHRH – GH –IGF-1 axis is a common target in sports doping. All three compounds, as well as their analogues, are banned by the World Anti-Doping Agency (WADA) at all times. Besides curating the list of prohibited compounds, WADA also provides doping control laboratories with a set of minimum required performance levels (MRPL) for these compounds. These MRPLs indicate the sensitivity that a detection method should achieve for a certain compound and are commonly based on administration studies. Since doping often corresponds to the illicit use of prescription medicine, administration studies for many prohibited compounds have only been performed in the context of a clinical trial involving a specific patient population. This research project aims to perform a Tesamorelin administration study on six healthy volunteers. This will allow for a re-evaluation of the current MRPL using a study population more representative of healthy athletes, as well as generate insight into the urinary excretion pattern of Tesamorelin. Both are important factors for the anti-doping community in evaluating the performance of detection methods. For the second objective of this project, the influence of Tesamorelin administration on serum IGF-1 levels will be monitored to investigate the possibility of using IGF-1 as a long-term marker for GHRH doping. Also P-III-NP levels will be assessed to evaluate if the IGF-1/P-III-NP ratio (as will be applied in the endocrine module of the athlete biological passport) is a stronger marker than IGF-1 alone to detect Tesamorelin abuse and GH secretagogues in general in sport.

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