The Effect of Insulin on Infarct Size and Neurologic Outcome After Acute Stroke
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Acute Ischemic Stroke Hyperglycemia |
Drug: Insulin |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 133 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients aged > 18 years presenting to the Emergency Department with symptoms of acute ischemic stroke will be included for study.
- Acute stroke patients with normal blood glucose levels and patients with fingerstick blood glucose level of greater than or equal to 130 mg/dl will be eligible for study.
- Acute Stroke will be defined as an acute disturbance of cerebral function of presumed vascular origin causing a neurological deficit of less than 24 hours duration.
- Patients must have an NIH Stroke Scale Score of 4 to 23. Patients awakening with symptoms of stroke will be considered to have had their stroke at the time when last awake without symptoms.
Exclusion Criteria:
- Patients presenting after 24 hours of symptom onset. When the actual time of onset is unknown, the time when last observed to be symptom-free will be used.
- Patients with NIH scale of less than 4 or greater than 23.
- Complete or substantial resolution of symptoms before randomization.
- Patients with a previously disabling stroke (modified Rankin score > 3)
- Patients with other systemic disease such as infection (eg pneumonia, etc)
- Patients with hemorrhage visualized on CT.
- Patients who are unwilling or unable to give informed consent, or for whom a legally authorized representative is not able to consent.
- Pregnant patients.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Nina T. Gentile, M.D., Temple University |
| ClinicalTrials.gov Identifier: | NCT00373269 History of Changes |
| Other Study ID Numbers: | 3866 |
| Study First Received: | September 5, 2006 |
| Last Updated: | August 10, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Temple University:
|
Acute ischemic stroke Stroke Hyperglycemia Insulin |
Progoagulation Diabetes Blood coagulation |
Additional relevant MeSH terms:
|
Hyperglycemia Infarction Ischemia Stroke Cerebral Infarction Glucose Metabolism Disorders Metabolic Diseases Pathologic Processes Necrosis Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013