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Sponsored by: |
Temple University |
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Information provided by: | Temple University |
ClinicalTrials.gov Identifier: | NCT00373269 |
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 |
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Acute Ischemic Stroke Hyperglycemia |
Drug: Insulin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Effect of Insulin on Infarct Size and Neurologic Outcome After Acute Stroke |
Estimated Enrollment: | 133 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | January 2010 |
Estimated 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nina T Gentile, MD | (215) 707-7550 | ngentile@temple.edu |
United States, Pennsylvania | |
Temple University Hospital | Recruiting |
Philadelphia, Pennsylvania, United States, 19140 | |
Contact: Nina T Gentile, MD 215-707-8402 ngentile@temple.edu |
Principal Investigator: | Nina T Gentile, MD | Temple University |
Responsible Party: | Temple University ( Nina T. Gentile, M.D. ) |
Study ID Numbers: | 3866 |
Study First Received: | September 5, 2006 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00373269 History of Changes |
Health Authority: | United States: Institutional Review Board |
Acute ischemic stroke Stroke Hyperglycemia Insulin |
Progoagulation Diabetes Blood coagulation |
Metabolic Diseases Cerebral Infarction Stroke Diabetes Mellitus Vascular Diseases Central Nervous System Diseases Ischemia Brain Diseases Cerebrovascular Disorders |
Insulin Hypoglycemic Agents Hyperglycemia Brain Ischemia Brain Infarction Infarction Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Cerebral Infarction Physiological Effects of Drugs Stroke Nervous System Diseases Vascular Diseases Central Nervous System Diseases Brain Diseases Cerebrovascular Disorders |
Pharmacologic Actions Insulin Hypoglycemic Agents Hyperglycemia Brain Ischemia Cardiovascular Diseases Brain Infarction Glucose Metabolism Disorders |