Neurological Complications at Stroke Patients With Diabetes Mellitus (SDM)

This study has been completed.
Information provided by:
Evangelisches Krankenhaus Bielefeld gGmbH Identifier:
First received: July 28, 2010
Last updated: June 21, 2011
Last verified: June 2011
It is to be investigated if a correlation exist between the development of the HbA1c value and the complication rate is following a stroke.

Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Neurological Complications at Stroke Patients With Diabetes Mellitus During the First Six Months After a Cerebral Ischemia

Further study details as provided by Evangelisches Krankenhaus Bielefeld gGmbH:

Primary Outcome Measures:
  • Functional outcome six months after the cerebral ischemia [ Time Frame: six months ] [ Designated as safety issue: No ]
    Functional outcome for the National Institutes of Health Stroke scale, the Barthel Index and Modified Ranking Scala six months after the cerebral ischemia.

Secondary Outcome Measures:
  • Additional cerebral ischemia [ Time Frame: six months ] [ Designated as safety issue: No ]
    Additional cerebral ischemia six months after the first cerebral ischemia

  • Mortality [ Time Frame: sixt months ] [ Designated as safety issue: No ]
    Mortality in the first 6 months after the primary cerebral ischemia

Enrollment: 100
Study Start Date: August 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
HbA1c ≤ 7
Stroke patients with mild diabetes mellitus HbA1c ≤ 7
HbA1c ≥ 7,5
Stroke patients with severe diabetes mellitus HbA1c ≥ 7,5

Detailed Description:

The immediate objective of the study is to find out if a correlation between blood sugar control in diabetics and the incidence of complications after a stroke exists.

The study has a high practical importance because any consequences in the treatment of diabetes mellitus can be implemented without affecting costs.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stroke patients on the Stroke Unit with hyperglycemia with cerebral ischemia within the last 24 hours

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with intracerebral hemorrhage
  • Pregnant patients
  • Patients with sensory aphasia
  Contacts and Locations
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Please refer to this study by its identifier: NCT01172977

Evangelisches Krankenhaus
Bielefeld, Germany, 33167
Sponsors and Collaborators
Evangelisches Krankenhaus Bielefeld gGmbH
Principal Investigator: Cristian Barzu, MD Evangelisches Krankenhaus Bielefeld, Germany
  More Information

Additional Information:
Responsible Party: Barzu Cristian Identifier: NCT01172977     History of Changes
Other Study ID Numbers: EvKB Barzu  DRKS00000470 
Study First Received: July 28, 2010
Last Updated: June 21, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Evangelisches Krankenhaus Bielefeld gGmbH:
Diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nervous System Diseases
Vascular Diseases processed this record on May 24, 2016