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Trial record 12 of 33 for:    klinefelter

Thrombosis and Neurocognition in Klinefelter Syndrome

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ClinicalTrials.gov Identifier: NCT02526628
Recruitment Status : Completed
First Posted : August 18, 2015
Last Update Posted : August 22, 2019
Sponsor:
Collaborators:
Aarhus University Hospital
Hospital of South West Denmark
University of Southern Denmark
Sygehus Lillebaelt
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date August 10, 2015
First Posted Date August 18, 2015
Last Update Posted Date August 22, 2019
Study Start Date September 2015
Actual Primary Completion Date August 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 14, 2015)
  • Differences in thrombin generation [ Time Frame: Time 0 and after 18 months followup ]
    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.
  • Differences in fibrin clot properties [ Time Frame: Time 0 and after 18 months followup ]
    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.
  • Difference in neurocognition [ Time Frame: Time 0 and after 18 months followup ]
    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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02526628 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 14, 2015)
  • Differences in blood coagulation and fibrinolysis parameters between groups [ Time Frame: Time 0 and after 18 months followup ]
    Coagulation and fibrinolysis can not be adequately assessed by analysis of a single parameter. To evaluate the overall status of these systems an array of analyses are needed, and further more need to be interpreted by experts within the field. Thus, severeal markers of coagulation and fibrinolysis including INR, APTT, single coagulation factors, PAI-1 and others are to be 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. Besides applying statistics, the compiled results will also be interpreted by experts within the field to provide an overall characterization of the haemostatic balance in the individual groups and by comparison to each other.
  • Differences in fMRI between groups [ Time Frame: Once at followup ]
    fMRI will be performed to evaluate the response in the brain to various stimuli and tests, with the overall purpose of examining speech, memory and other cognition related features.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Thrombosis and Neurocognition in Klinefelter Syndrome
Official Title The Haemostatic Balance and Neurocognitive Phenotype in Klinefelter Syndrome - The Effect of Testosterone Treatment
Brief Summary 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.
Detailed Description

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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Bloodsamples
Sampling Method Non-Probability Sample
Study Population Men with Klinefelter syndrome identified through clinics for fertility, endocrinology and genetics. Healthy controls from the general population living in Central Denmark Region.
Condition
  • Klinefelter Syndrome
  • Thrombosis
Intervention Not Provided
Study Groups/Cohorts
  • Testosterone naïve KS
    Men with Klinefelter syndrome without testosterone treatment. After initial examination standard treatment with testosterone will be effectuated according to current guidelines.
  • Testosterone treated KS
    Men with Klinefelter syndrome receiving testosterone treatment
  • Controls 1
    Matched healthy male controls for testosterone naive KS
  • Controls 2
    Matched healthy male controls for testosterone treated KS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 21, 2019)
90
Original Estimated Enrollment
 (submitted: August 14, 2015)
120
Actual Study Completion Date August 21, 2019
Actual Primary Completion Date August 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Klinefelter syndrome with 47 XXY karyotype
  • Healthy male

Exclusion Criteria:

  • Known thrombophilia
  • Previous thrombotic event
  • Chronic or acute illness affecting the haemostatic balance (e.g. diabetes, cancer).
  • Previous or current disease affecting the brain
  • Weight above 120 kg
  • Current abuse of stimulants affecting the brain
  • Unability to complete MR-scan (e.g. claustrophobia, internal metal objects)
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02526628
Other Study ID Numbers 2015_KS_TESTOSTERONE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Aarhus
Study Sponsor University of Aarhus
Collaborators
  • Aarhus University Hospital
  • Hospital of South West Denmark
  • University of Southern Denmark
  • Sygehus Lillebaelt
Investigators
Study Chair: Claus H Gravholt, MD, Prof. Department of Endocrinology and Internal Medine and Department of Molecular Medicine
Principal Investigator: Simon Chang, MD Unit for Thrombosis Research
Principal Investigator: Anne Skakkebæk, MD, PhD Department of Clinical Genetics
PRS Account University of Aarhus
Verification Date January 2018