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Neurological Complications at Stroke Patients With Diabetes Mellitus (SDM)

This study has been completed.
Sponsor:
Information provided by:
Evangelisches Krankenhaus Bielefeld gGmbH
ClinicalTrials.gov Identifier:
NCT01172977
First received: July 28, 2010
Last updated: June 21, 2011
Last verified: June 2011
History of Changes
  Purpose

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


Condition
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

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)
Groups/Cohorts
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.

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172977

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

Additional Information:
webpage about the study  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Barzu Cristian
ClinicalTrials.gov 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
Stroke

Additional relevant MeSH terms:
Diabetes Mellitus
Stroke
Cerebral Infarction
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 19, 2013