An observational study in Ischemic Stroke and Hyperglycemia, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-03-23.
Sponsored by University of Minnesota · Observational
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.
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.
1.3 Pre-clinical Data Currently there is clear data that patients that present with acute ischemic stroke have higher (two times) mortality at discharge and 90 day mark. Multiple clinical studies so far have not revealed any clear benefit of treatment (GIST-UK). There do seem to be two distinct groups when it comes to hyperglycemia at presentation of DM, HG in association of Diabetes and without any history of Diabetes. The outcomes in the two groups vary greatly.
1.4 Clinical Data to Date Please see attached article with references.
1.5 Dose Rationale and Risk/Benefits There is no drug or device or intervention that will be tested in this study. This study involves collection of blood samples from the patients who meet the inclusion criteria. Our goal is to be able to see if there is any difference between the two groups of patients.
2 Study Objectives
Primary Objective: Assess difference in laboratory values between two groups of patients.
Null Hypothesis: There is no difference in laboratory values between DH and NDH
3 Study Design
3.1 General Design This is a exploratory study to assess the difference in the lab values in two groups of patients. Patients that present to University of Minnesota Medical Center with acute ischemic stroke and are hyperglycemic (Blood sugar of more than 130 mg/dl) will be eligible for the study. Pre-specified volume of blood will be collected for lab analysis. This study does not involve testing of any procedure, drug or device.
Step One - Identify patients that have Ischemic strokes and have hyperglycemia >130 mg/dl.
Step Two:
- Obtain Consent from patient or POA.
Step Three:(Once consent obtained) - Collect first set of blood samples from patients with the first blood draw between 0-8 hours from time of ER arrival. Second blood sample will be collected in 9-16 hours and a 3rd one in 17-24 hour period.
Step Four:
- No further data will be collected from patient. Study end point is difference in laboratory values between DH and NDH groups.
2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.
This study's enrollment of 88 is below the median of 300 across 787 observational studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →University of Minnesota is the lead sponsor of 1,210 studies on the registry; 195 are open to participants now.
Of its 133 completed or terminated interventional studies of FDA-regulated products, 92 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Acute Ischemic Stroke Patients that present to University of Minnesota Medical Center and Hennipen County medical Center.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
None is planned
Difference in the Bio markers of stress between Diabetic and Non diabetic patients that have acute ischemic stroke and hyperglycemia on presentation.
Lab values
Time frame: 24 hours
Plan to share: No
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.