Thrombosis Clinical Trial
Official title:
The Haemostatic Balance and Neurocognitive Phenotype in Klinefelter Syndrome - The Effect of Testosterone Treatment
The haemostatic balance and neurocognitive capability of men with Klinefelter syndrome is compared to healthy controls by using specific biochemical assays for coagulation and fibrinolysis and a selection of neuropsychological tests and brain fMRI. Furthermore, the effect of gonadal status and any effects of long- or short-term testosterone treatment on the above mentioned parameters are investigated.
Klinefelter syndrome (KS) affects approximately 1 in every 600 males, but remains severely
underdiagnosed. Men with KS are more prone to a wide range of diseases including thrombotic
disorders. Also, neurocognitive function is impaired in KS. The background for the increased
thrombosis proneness is not understood, and also it is not understood how testosterone
treatment affects the thrombosis risk in KS. The effects of testosterone treatment on
neurocognition in KS is also not completely understood. However, it is speculated that
testosterone treatment at an early point could help improve the overall neurocognitive
performance.
In this study 30 males with KS receiving testosterone treatment, 30 males with KS not
receiving testosterone treatment and 60 matched healthy male controls are included. After
initial examination including blood testing and neurocognitive testing, the subjects are
followed for 18 months and examined a second time. After initial examination the group of
previously untreated KS males will be put on standard testosterone treatment according to
current guidelines.
Groups will be compared by measuring and array of markers for coagulation and fibrinolysis,
including thrombin generation and fibrin structure analysis, to assess the haemostatic
balance. Also, a wide array of neurocognitive tests and brain fMRI is applied to compare the
neurocognitive function between the groups.
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