Trial document




drksid header

  DRKS00000470

Trial Description

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Title

Neurological complications in stroke patients with diabetes mellitus during the first six months of the onset of cerebral ischemia

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Trial Acronym

SDM

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URL of the Trial

http://www.barzu.eu

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Brief Summary in Lay Language

The immediate objective of the study is to find out is the connection between blood sugar control in diabetics and the incidence of complications after a stroke.
The study has cost a high practical value because any consequences in the treatment of diabetes mellitus and may be implemented ressourcenneutral.

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Brief Summary in Scientific Language

It is to be investigated if a correlation exist between the development of the HbA1c value and the complication rate is following a stroke.

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Organizational Data

  •   DRKS00000470
  •   2010/07/20
  •   2010/07/29
  •   yes
  •   Approved
  •   2010-177-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   U1111-1116-3284 
  •   NCT01172977  (clinicaltrials.gov)
  •   - 
  •   - 
  •   - 
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Health Condition or Problem studied

  •   G46 -  Vascular syndromes of brain in cerebrovascular diseases
  •   E11 -  Non-insulin-dependent diabetes mellitus
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Interventions/Observational Groups

  •   Stroke patients with mild diabetes mellitus HbA1c ≤ 7
  •   Stroke patients with severe diabetes mellitus HbA1c ≥ 7
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Characteristics

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

Functional outcome for the National Institutes of Health Stroke scale,
the Barthel Index and Modified Ranking Scala six months after the cerebral ischemia.

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Secondary Outcome

Fresh cerebral ischemia / TIA;
Other vascular Erreignis;
Mortality in the first 6 months after the primary cerebral ischemia

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Planned
  •   2010/08/01
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Stroke patients on the Stroke Unit with hyperglycemia with cerebral ischemia within the last 24 hours

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Exclusion Criteria

Patients with intracerebral hemorrhage;
Pregnant patients;
Patients with sensory aphasia

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Addresses

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    • Evangelisches Krankenhaus Bielefeld Neurologische Klinik in Bethel
    • Mr.  Prof.Dr.med.  Wolf Rüdiger  Schäbitz 
    • Burgsteig 13
    • 33167  Bielefeld
    • Germany
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    •   0521/77278301
    •   0521/77278302
    •   [---]*
    •   http://www.evkb.de
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    • Evangelisches Krankenhaus Bielefeld Neurologische Klinik in Bethel
    • Mr.  Cristian  Barzu 
    • Burgsteig 13
    • 33167  Bielefeld
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Evangelisches Krankenhaus Bielefeld Neurologische Klinik in Bethel
    • Mr.  Cristian  Barzu 
    • Burgsteig 13
    • 33167  Bielefeld
    • Germany
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Sources of Monetary or Material Support

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    • Evangelisches Krankenhaus Bielefeld
    • Burgsteig 13
    • 33167  Bielefeld
    • Germany
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    •   05 217 727 83 01
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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