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Title Stroke Hyperglycemia Insulin Network Effort Trial
Therapeutic Area Stroke
Principal Investigator Joshua Kornbluth, MD
Min Age 18 Years
Gender Both
Contact Haley Huggins
617-636-7606
More Information http://clinicaltrials.gov/ct2/show/NCT01369069

Overview

The purpose of this study is to find out the effects of controlling blood sugar within a narrow range by giving IV insulin in patients with high blood sugar within 12 hours of developing symptoms of a stroke. The study is to determine if giving IV insulin to people with high blood sugar and who have had a stroke can improve recovery as compared to those who receive insulin by an injection under the skin. Studies have shown that high blood sugar levels during a stroke could be associated with more damage to the brain than normal blood sugar levels. Blood sugar levels can be lowered with insulin. The five different insulins that will be used in this study are approved by the FDA and are approved for this use as well. A subject will be assigned to one of 2 study groups: IV insulin and subcutaneous insulin. The subject will have a 50% chance to be assigned in one of the two groups by an internet-based randomization system.

Study Details

Inclusion Criteria

  • Clinical diagnosis of ischemic stroke
  • Treatment must begin within 12 hours of stroke symptom onset
  • Known history of type 2 diabetes mellitus and sugar levels >110 mg/dL or upon admission sugar levels ≥150 mg/dL in those without known diabetes mellitus

Exclusion Criteria

  • Known history of type 1 diabetes mellitus
  • Pre-existing neurological or psychiatric illness
  • Renal dialysis

Study Requirements

Number of research visits: 2 visits- after a patient is discharged from the hospital they will be contacted via telephone for their 6 week follow-up and the 3 month visit will be in the Neurology clinic. If a patient cannot come in for their 3 month visit, they can be contacted via telephone.

Length of participation: 90 days

Number of insulin shots: 2-5 shots per day

Number of finger sticks: 8-20 fingersticks per day

Volume of blood collected: 1 tablespoon total