Trial document





This trial has been registered retrospectively.
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  DRKS00000514

Trial Description

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Title

Investigation of metabolic profile, body tissue loss and change of the quality of life
in patients with ischaemic stroke.

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Trial Acronym

BoSSS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Investigation of metabolic imbalance, tissue wasting and body composition changes in patients after stroke, in particular of structural and functional changes of metabolic profile, insulin sensitivity and the quality of life.

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Brief Summary in Scientific Language

The purpose of the study is a comprehensiv prospectiv clinical and pathophysiological characterization of patients after territorial or lacunar, ischaemic stroke in the area of the Arteria cerebri media concerning the metabolic profile – in particular of structural and functional changes of metabolic profile, insulin sensitivity and the quality of life.

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Organizational Data

  •   DRKS00000514
  •   2011/01/18
  •   [---]*
  •   yes
  •   Approved
  •   EA2/008/09, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1116-7700 
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Health Condition or Problem studied

  •   I63.5 -  Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries
  •   I63.8 -  Other cerebral infarction
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Interventions/Observational Groups

  •   Observational group: patients after territorial or lacunar, ischaemic stroke in the area of the Arteria cerebri media
  •   healthy control
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Prognosis
  •   Other
  •   N/A
  •   [---]*
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Primary Outcome

changes in body composition (DEXA) after 12 month

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Secondary Outcome

changes in insulin sensitivity (intravenous glucose tolerance test),
endothelfunction (EndoPAT), peripheral blood flow (body Plethysmography) after 12 and 24 month

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/05/28
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   21   Years
  •   no maximum age
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Additional Inclusion Criteria

patients with lacunar or territorial ischaemic infarct in the area of the Arteria cerebri media. Severity of stroke according to the National Institute of Health - Stroke Scale (NIHSS) 5-12 and written consent.

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Exclusion Criteria

Patients with acute or chronic inflammatory decompensation, auto immune disease, M. Crohn, tuberculosis, AIDS, acute myocarditis, chronic lung disease, liver cirrhosis, disease of the thyroid glad, malignancy, acute infections, atrophic muscular disease, organ transplantation and immunsuppressive therapy.

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Addresses

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    • Center for Stroke Research Berlin, Charite, Universitätsmedizin Berlin, Campus Virchow-Klinikum
    • Mr.  Prof.Dr.Dr.  Wolfram  Doehner 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Center for Stroke Research Berlin(CSB), Charite, Campus Virchow-Klinikum
    • Mr.  Prof.Dr.Dr.  Wolfram  Doehner 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Centrum für Schlaganfallforschung Berlin, Charite, Universitätsmedizin Berlin, Campus Virchow-Klinikum
    • Ms.  Dr  Nadja  Scherbakov 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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* This entry means the parameter is not applicable or has not been set.