StrokeSDMNCT01172977
Neurological Complications at Stroke Patients With Diabetes Mellitus
An observational study of Stroke and Diabetes Mellitus, run by Evangelisches Krankenhaus Bielefeld gGmbH at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Diabetes Mellitus
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2010to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients on the Stroke Unit with hyperglycemia with cerebral ischemia within the last 24 hours
Who may be able to join
- Stroke patients on the Stroke Unit with hyperglycemia with cerebral ischemia within the last 24 hours
Who cannot join
- Patients with intracerebral hemorrhage
- Pregnant patients
- Patients with sensory aphasia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurological Complications at Stroke Patients With Diabetes Mellitus During the First Six Months After a Cerebral Ischemia
It is to be investigated if a correlation exist between the development of the HbA1c value and the complication rate is following a stroke.
Read the 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.
- Conditions
- Stroke, Diabetes Mellitus
- Keywords
- Diabetes mellitus, Stroke
- Medical subject headings
- Stroke, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HbA1c ≤ 7 | Stroke patients with mild diabetes mellitus HbA1c ≤ 7 | |
| HbA1c ≥ 7,5 | Stroke patients with severe diabetes mellitus HbA1c ≥ 7,5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six months
Secondary outcomes (2)
Additional cerebral ischemia
Additional cerebral ischemia six months after the first cerebral ischemia
Measured: six months
Mortality
Mortality in the first 6 months after the primary cerebral ischemia
Measured: sixt months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evangelisches Krankenhaus Bielefeld gGmbH
- Sponsor type
- University, hospital or other
- Investigators
- Cristian Barzu, MD, Principal investigator, Evangelisches Krankenhaus Bielefeld, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172977
- Sponsor's protocol ID
- EvKB Barzu
- Other IDs
- DRKS00000470
- Acronym
- SDM
- Status last verified
- Jun 2011
- First submitted
- 28 Jul 2010
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Complications at Stroke Patients With Diabetes Mellitus During the First Six Months After a Cerebral Ischemia
- ClinicalTrials.gov ID
- NCT01172977
- Acronym / sponsor ID
- SDM / EvKB Barzu
- Conditions
- Stroke, Diabetes Mellitus
- Keywords
- Diabetes mellitus, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Evangelisches Krankenhaus Bielefeld gGmbHUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 30 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HbA1c ≤ 7 | – | –Stroke patients with mild diabetes mellitus HbA1c ≤ 7 |
| HbA1c ≥ 7,5 | – | –Stroke patients with severe diabetes mellitus HbA1c ≥ 7,5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients on the Stroke Unit with hyperglycemia with cerebral ischemia within the last 24 hours
Key inclusion criteria (1 listed)
- Stroke patients on the Stroke Unit with hyperglycemia with cerebral ischemia within the last 24 hours
Key exclusion criteria (3 listed)
- Patients with intracerebral hemorrhage
- Pregnant patients
- Patients with sensory aphasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional outcome six months after the cerebral ischemia
Time frame: six months
Functional outcome for the National Institutes of Health Stroke scale, the Barthel Index and Modified Ranking Scala six months after the cerebral ischemia.
2 secondary outcomes
Additional cerebral ischemia
Time frame: six months
Mortality
Time frame: sixt months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristian Barzu, MD principal investigator
Evangelisches Krankenhaus Bielefeld, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Diabetes Mellitus, run by Evangelisches Krankenhaus Bielefeld gGmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome six months after the cerebral ischemia (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.