"Is Non Diabetic Hyperglycemia in Acute Ischemic Stroke Part of a Systemic Stress Response"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Difference in the Bio markers of stress between Diabetic and Non diabetic patients that have acute ischemic stroke and hyperglycemia on presentation.
Study Overview
Brief Summary
Hyperglycemia is present in 50 percent of patients with acute ischemic stroke. Patients with hyperglycemia have higher in hospital, 30 and 90 day mortality and morbidity. Sixty percent of these patients have some form of diabetic syndrome, known or unknown. Remaining 40% of patients are not diabetic. Contrary to logic patients with non diabetic hyperglycemia (NDH) have statistically higher morbidity and mortality compared to the diabetic hyperglycemia (DH) cohort. So far multiple treatment trials (THIS, GRASP, GIST-UK, SHINE ongoing) with differing treatment goals have shown no clear benefit, however no obvious distinction was made along the diabetic and non-diabetic hyperglycemic groups.
If hyperglycemia in the acute phase was the only culprit in worsening the injury, then there should be no difference in the outcomes for DH and NDH. Existing data implies that the two categories are two distinct physiological entities that are thus not amenable to same treatment. Stating it simply NDH is not an insulin deficient state where as DH is.
Alternative possibility is that body and Neurons are accustomed to high sugars in diabetics and thus can tolerate higher sugars better during ischemic stroke compared to non diabetics.
The overarching hypothesis is that reducing blood sugars in NDH increases stroke volume and thus consequently worsens outcome.
Detailed Description
1.1 Background Hyperglycemia is present in 50 percent of patients with acute ischemic stroke. Patients with hyperglycemia have higher in hospital, 30 and 90 day mortality and morbidity. Sixty percent of these patients have some form of diabetic syndrome, known or unknown. Remaining 40% of patients are not diabetic. Contrary to logic patients with non diabetic hyperglycemia (NDH) have statistically higher morbidity and mortality compared to the diabetic hyperglycemia (DH) cohort. So far multiple treatment trials (THIS, GRASP, GIST-UK, SHINE ongoing) with different treatment goals have shown no clear benefit.
If hyperglycemia in the acute phase was the only culprit in worsening the injury, then there should be no difference in the outcomes for DH and NDH. Existing data implies that the two categories are distinct physiological entities that are thus not amenable to same treatment. Stating it simply NDH is not an insulin deficient state where as DH is.
Alternative possibility is that body and Neurons are accustomed to high sugars in diabetics and thus can tolerate higher sugars better during ischemic stroke compared to non diabetics.
The overarching hypothesis is that reducing blood sugars in NDH increases stroke volume and thus consequently worsens outcome.
1.2 Investigational Agent: No planned investigational agent is tested as part of this study.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with acute Ischemic stroke that present to UMMC ER.
- •Subjects are hyperglycemic (defined as blood sugar above 130mg/dl).
Exclusion Criteria
- •Blood sugars less than 130mg/dl.
- •Age less than 18 or more than
- •Difficult blood draw.
Outcomes
Primary Outcomes
Difference in the Bio markers of stress between Diabetic and Non diabetic patients that have acute ischemic stroke and hyperglycemia on presentation.
Time Frame: 24 hours
Lab values
Secondary Outcomes
No secondary outcomes reported