The Effect of Insulin on Infarct Size and Neurologic Outcome After Acute Stroke
Between twenty and fifty percent of people who have acute stroke have hyperglycemia (high blood sugar) with it. Research has shown an association between hyperglycemia and poor recovery from stroke. However, it is not known if treating the hyperglycemia—bringing the blood sugar back to normal range—will improve the patient's recovery from stroke. This purpose of this study is to see if giving Insulin to normalize the blood sugar will decrease the size of the stroke in the brain and improve the patient's neurologic recovery.
We hypothesize that early insulin administration to normalize blood glucose levels may be beneficial in cerebral ischemia and stroke.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Insulin on Infarct Size and Neurologic Outcome After Acute Stroke|
- Change in infarct volume at Week 1 from baseline as measured on diffusion - perfusion magnetic resonance imaging [ Time Frame: baseline to one week ] [ Designated as safety issue: No ]
- Analyses of group mean infarct volume and the mean percent change from baseline to Week 1 [ Time Frame: baseline to one week ] [ Designated as safety issue: No ]
- Blood sugar [ Time Frame: hour 0.25, 0.5, 1, 2,4,6,8,12,16,20,24, 36, 48 ] [ Designated as safety issue: Yes ]
- Coagulation Studies [ Time Frame: hour 0, 6,12,24,48 ] [ Designated as safety issue: No ]
- Neurological Assessment: NIHSS, Barthel Index, Modified Rankin Score [ Time Frame: hr 0, 48, week 1 and week 12 ] [ Designated as safety issue: No ]
- Mortality rates [ Time Frame: hour 0 to one week ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2004|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Insulin, by lowering blood glucose levels, has been shown to rescue ischemically threatened but potentially viable tissue of the penumbra surrounding the core of dead tissue. Insulin appears to act directly on the neuron and indirectly by lowering peripheral blood glucose. It has proven effective in animal models of stroke, and has a favorable toxicologic and cardiovascular profile. Dosing in this study will be individualized. The initial dose and subsequent doses will be modulated to maintain serum glucose levels between 80 and 110 mg/dL.
The first objective of this study is to determine the safety and efficacy of intravenous insulin versus Standard Treatment in patients with suspected cerebral infarction. The primary outcome parameter will be infarct volume at Week 1 as measured on diffusion - perfusion magnetic resonance imaging. Secondary analyses of efficacy will be the effect of insulin on neurologic function as measured by the Modified Rankin Scale, the National Institutes of Health Stroke Scale, and the Barthel Index. Analysis of safety will include analyses of physical exam, adverse events, vital signs, laboratory data, hemorrhage and reinfarction rates and mortality rates.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373269
|Principal Investigator:||Nina T Gentile, MD||Temple University|