The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Description:

More than 795,000 people in the United States suffer from strokes annually, and an estimated 40 percent of people with acute ischemic stroke also have high blood sugar, or hyperglycemia. Although hyperglycemia is known to be associated with worse recovery for individuals with stroke, it is unclear if treatment interventions intended to bring blood sugar to normal levels can improve recovery without the risk of inducing hypoglycemia (low blood sugar levels).

SHINE is a multicenter, randomized, controlled clinical trial of 1400 participants that will include approximately 60 sites across the country. The trial will evaluate if blood sugar control is safe and effective for improving stroke recovery. The research sites will be testing the current standard treatment against the administration of a controlled IV insulin infusion therapy in eligible participants who present within 12 hours of the onset. The treatment lasts for up to three days.

Eligible participants will have a history of diabetes or may have undiagnosed diabetes and elevated blood glucose on initial evaluation and will have to get to the hospital very quickly after the start of symptoms. The study researchers are trying to understand the best way to manage blood sugar after a stroke to improve recovery.

Eligibility Criteria:

Inclusion Criteria:

  1. Age 18 years or older
  2. Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more cerebral vascular territories. Neuroimaging must be done to exclude intracranial hemorrhage (ICH).
  3. Subject randomization must be within 12 hours after stroke symptom onset and is recommended, but not required, to begin within 3 hours after hospital arrival. If time of symptom onset is unclear or patient is awakening with stroke symptoms, the time of onset will be the time the patient was last known to be normal.
  4. Known history of type 2 diabetes mellitus and glucose >110 mg/dL OR admission blood glucose ≥150 mg/dL in those w/o known diabetes mellitus
  5. Baseline NIHSS score of 3-22
  6. Pre-stroke modified Rankin Scale score = 0 for patients with an NIHSS score of 3-7. Pre-stroke modified Rankin Scale score = 0 or 1 for patients with an NIHSS score of 8-22.
  7. Able to provide a valid informed consent to be in the study (self or their authorized legally accepted representative). The approved consent form must be signed and dated in accordance with federal and institutional guidelines.

Exclusion Criteria:

  1. Known history of type 1 diabetes mellitus
  2. Substantial pre-existing neurological or psychiatric illness that would confound the neurological assessment or other outcome assessment
  3. Having received experimental therapy for the enrollment stroke. IV tPA (up to 4.5 hrs) or IA tPA are allowed as are IA therapies including use of FDA cleared devices. Non FDA cleared devices are considered experimental and are excluded.
  4. Pregnant or breast-feeding at the time of study entry
  5. Other serious conditions that make the patient unlikely to survive 90 days
  6. Inability to follow the protocol or return for the 90 day follow up
  7. Renal dialysis (including hemo or peritoneal dialysis)

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Study Location:

Multiple U.S. Locations