Neurological Complications at Stroke Patients With Diabet... | NCT01172977

Studies
Neurological Complications at Stroke Patients With Diabetes Mellitus

NCT01172977

Sponsor

Evangelisches Krankenhaus Bielefeld gGmbH

Status

Completed

Last Update Posted

Jun 23, 2011Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Stroke
Diabetes Mellitus

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
DRKS00000470	Other Identifier	German Clinical Trials Register

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Jul 28, 2010

First Submission Date that Met QC Criteria

Jul 28, 2010

First Posted Date

Jul 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2011

Last Update Posted Date

Jun 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HbA1c ≤ 7		Stroke patients with mild diabetes mellitus HbA1c ≤ 7
HbA1c ≥ 7,5		Stroke patients with severe diabetes mellitus HbA1c ≥ 7,5

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Additional cerebral ischemia	Additional cerebral ischemia six months after the first cerebral ischemia	six months
Mortality	Mortality in the first 6 months after the primary cerebral ischemia

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cristian Barzu, MD	Evangelisches Krankenhaus Bielefeld, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Evangelisches Krankenhaus		Bielefeld		33167	Germany

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided