Clinical Trial to Test Stroke Treatment for Diabetics

CT scan of the brain six days after acute stroke. (Institute for Neurological Research)

The University of Virginia Health System in Charlottesville has received a $25 million grant to lead a national clinical trial investigating a new treatment that could benefit ischemic stroke patients. The National Institutes of Neurological Diseases and Stroke, part of National Institutes of Health, is funding the study.

Ischemic stroke occurs when a blood vessel that supplies blood to the brain is blocked by a blood clot. If blood flow is stopped for longer than a few seconds, the brain cannot get blood and oxygen. Brain cells can die, causing permanent damage. A 2005 study indicates that diabetes is associated with a higher risk of death and disability after the onset of stroke.

The new clinical trial, called Stroke Hyperglycemia Insulin Network Effort (SHINE), will test approach to controlling sugar in the early period after stroke in diabetic patients. The more than 50 sites will compare the current standard treatment — sliding scale administration of insulin to keep glucose at less than 180 milligrams per decliter (mg/dL) — against the new treatment.

The new treatment to be tested calls for the administration of a controlled IV insulin infusion therapy to maintain target glucose concentrations of 80-130 mg/dL within 12 hours of the onset of stroke symptoms and lasting for up to three days. Eligible subjects will have diabetes and elevated blood glucose (at least greater than 110 mg/dL) on initial evaluation and will have to get to the hospital very quickly after the start of symptoms.

According the ClinicalTrials.gov, SHINE is expected to be a randomized, controlled clinical trial of 1,400 patients, age 18 or older, with a clinical diagnosis of ischemic stroke. The patients must also have a history of type 2 diabetes and glucose greater than 110 mg/dL, or with a glucose reading equal to or greater than 150 mg/dL and no history of diabetes.

University of Michigan and University of South Carolina are co-sponsors of the study that is scheduled to begin in August 2011. Data collection is expected to continue to July 2016.

Read more: Drug Reduces Stroke Victim Brain Inflammation, Disability

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