Researchers at the University of Virginia Health System have received a $25 million grant from the National Institutes of Health (NIH) to lead a 50+ center national clinical trial investigating a promising new treatment that could greatly benefit thousands of acute ischemic stroke patients every year.
More than 750,000 people in the United States suffer from strokes annually, and an estimated 40 percent of patients with acute ischemic stroke have high blood sugar, or hyperglycemia.
Although hyperglycemia is known to be associated with worse patient outcomes (death and disability), it is unclear if treatment interventions intended to bring blood sugar to normal levels can improve these outcomes without incurring the added risk of inducing hypoglycemia (low blood sugar levels).
With this new clinical trial, called Stroke Hyperglycemia Insulin Network Effort (SHINE), researchers hope to determine the efficacy of a novel approach to controlling sugar in the early period after stroke in diabetic stroke patients.
Research sites across the country will be testing the current standard treatment against the new treatment, which involves the administration of a controlled IV insulin infusion therapy 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 (i.e., at least greater than 110 mg/dL) on initial evaluation and will have to get to the hospital very quickly after start of symptoms.
"Our previous research has clearly shown that the insulin protocol will be safe for patients but also may improve their outcome after ischemic stroke," says Karen C. Johnston, MD, MSc, chair of the UVA Department of Neurology and principal investigator of the national trial.
"We could not be more excited about leading this effort to improve the care of stroke patients with diabetes," Johnston says. "This study will include stroke experts and stroke patients from all over the country, and the results will inform health care providers of best treatment approaches so patients all over the country will have better outcomes. Regardless of the results, this study will have a dramatic impact on us all."
Calling 911 as soon as someone suspects a stroke is still the most important thing for the public to remember so that doctors can rapidly treat and try to reverse stroke symptoms.
The SHINE trial is being sponsored by the NIH - National Institutes of Neurological Diseases and Stroke (NINDS).