Neurological Complications at Stroke Patients With Diabetes Mellitus

Stroke Clinical Trial

— SDM  

Official title:

Neurological Complications at Stroke Patients With Diabetes Mellitus During the First Six Months After a Cerebral Ischemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01172977
• Other study ID #: EvKB Barzu
• Secondary ID: DRKS00000470
• Status: Completed
• Phase: N/A
• First received: July 28, 2010
• Last updated: June 21, 2011
• Start date: August 2010
• Est. completion date: March 2011

Study information

• Verified date: June 2011
• Source: Evangelisches Krankenhaus Bielefeld gGmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Stroke

Locations

Country	Name	City	State
Germany	Evangelisches Krankenhaus	Bielefeld

Sponsors (1)

Lead Sponsor	Collaborator
Evangelisches Krankenhaus Bielefeld gGmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome six months after the cerebral ischemia	Functional outcome for the National Institutes of Health Stroke scale, the Barthel Index and Modified Ranking Scala six months after the cerebral ischemia.	six months	No
Secondary	Additional cerebral ischemia	Additional cerebral ischemia six months after the first cerebral ischemia	six months	No
Secondary	Mortality	Mortality in the first 6 months after the primary cerebral ischemia	sixt months	No

External Links

•   webpage about the study