NCT02526628|CompletedDMC
Thrombosis and Neurocognition in Klinefelter Syndrome
The Haemostatic Balance and Neurocognitive Phenotype in Klinefelter Syndrome - The Effect of Testosterone Treatment
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The Haemostatic Balance and Neurocognitive Phenotype in Klinefelter Syndrome - The Effect of Testosterone Treatment
Sponsor study identifier
observational
90
1 country
1
Study Start
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 21, 2019
Actual (reported)Study Completion
August 21, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 21, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 10, 2015
Actual (reported)August 18, 2015
Actual (reported)September 2015
Date type not reportedThis date has not been verified as actual or estimated.
August 21, 2019
Actual (reported)August 21, 2019
Actual (reported)Differences in thrombin generation
Thrombin generation using the CAT assay is assessed as ETP (nM thrombin), peak height (nM thrombin) and lag time (minutes). All variables are assessed at inclusion and after a 18 month follow-up. Groups are compared statistically at each time point and any changes during follow-up is also analysed.
Time 0 and after 18 months followup
Differences in fibrin clot properties
Fibrin clot properties is assessed by fibrin structure analysis in plasma samples. All variables are assessed at inclusion and after a 18 month follow-up. Groups are compared statistically at each time point and any changes during follow-up is also analysed.
Time 0 and after 18 months followup
Difference in neurocognition
neurocognition is assessed using a wide array of psychological tests (e.g. Wais-III, Stroop test, Wisconsin Card Sorting Test and others) All variables are assessed at inclusion and after a 18 month follow-up. Groups are compared statistically at each time point and any changes during follow-up is also analysed.
Time 0 and after 18 months followup
Differences in blood coagulation and fibrinolysis parameters between groups
Time 0 and after 18 months followup
Differences in fMRI between groups
Once at followup
Men with Klinefelter syndrome without testosterone treatment. After initial examination standard treatment with testosterone will be effectuated according to current guidelines.
Men with Klinefelter syndrome receiving testosterone treatment
Matched healthy male controls for testosterone naive KS
Matched healthy male controls for testosterone treated KS
Men with Klinefelter syndrome identified through clinics for fertility, endocrinology and genetics. Healthy controls from the general population living in Central Denmark Region.
Department for Endocrinology and Internal Medicine
Aarhus, 8000, Denmark
Chang S, Gravholt CH, Skakkebaek A, Munster AB, Palarasah Y. Contact Activation Is Alleviated by Testosterone Replacement Therapy in Klinefelter Syndrome: Evidence of Hormonal and Metabolic Modulation. Andrology. 2026 Mar 27. doi: 10.1111/andr.70220. Online ahead of print.
Viuff M, Skakkebaek A, Johannsen EB, Chang S, Pedersen SB, Lauritsen KM, Pedersen MGB, Trolle C, Just J, Gravholt CH. X chromosome dosage and the genetic impact across human tissues. Genome Med. 2023 Mar 28;15(1):21. doi: 10.1186/s13073-023-01169-4.
Bloodsamples
Claus H Gravholt, MD, Prof.
Department of Endocrinology and Internal Medine and Department of Molecular Medicine
Simon Chang, MD
Unit for Thrombosis Research
Anne Skakkebæk, MD, PhD
Department of Clinical Genetics
90 participants (actual enrollment reported by the registry).
First Submitted
August 10, 2015
First Posted
August 18, 2015
Study Start
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
Klinefelter Syndrome and Testosterone Treatment in Puberty
Contact the study team to confirm eligibility.
Primary Completion
August 21, 2019
Actual (reported)Study Completion
August 21, 2019
Actual (reported)Last Updated
August 22, 2019
Record last verified: 2018-01
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