The Effect of Insulin on Infarct Size and Neurologic Outcome After Acute Stroke

This study has been completed.
Sponsor:
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT00373269
First received: September 5, 2006
Last updated: August 10, 2011
Last verified: August 2011

September 5, 2006
August 10, 2011
January 2004
January 2010   (final data collection date for primary outcome measure)
  • Change in infarct volume at Week 1 from baseline as measured on diffusion - perfusion magnetic resonance imaging [ Time Frame: baseline to one week ] [ Designated as safety issue: No ]
  • Analyses of group mean infarct volume and the mean percent change from baseline to Week 1 [ Time Frame: baseline to one week ] [ Designated as safety issue: No ]
  • Change in infarct volume at Week 1 from baseline as measured on diffusion - perfusion magnetic resonance imaging
  • Analyses of group mean infarct volume and the mean percent change from baseline to Week 1
Complete list of historical versions of study NCT00373269 on ClinicalTrials.gov Archive Site
  • Blood sugar [ Time Frame: hour 0.25, 0.5, 1, 2,4,6,8,12,16,20,24, 36, 48 ] [ Designated as safety issue: Yes ]
  • Coagulation Studies [ Time Frame: hour 0, 6,12,24,48 ] [ Designated as safety issue: No ]
  • Neurological Assessment: NIHSS, Barthel Index, Modified Rankin Score [ Time Frame: hr 0, 48, week 1 and week 12 ] [ Designated as safety issue: No ]
  • Mortality rates [ Time Frame: hour 0 to one week ] [ Designated as safety issue: Yes ]
  • Blood sugar: at hour 0.25, 0.5, 1, 2,4,6,8,12,16,20,24, 36, 48
  • Coagulation Studies at hour: 0, 6,12,24,48
  • Neurological Assessment hr 0, 48, week 1 and week 12: NIHSS, Barthel Index, Modified Rankin Score
  • Mortality rates
Not Provided
Not Provided
 
The Effect of Insulin on Infarct Size and Neurologic Outcome After Acute Stroke
The Effect of Insulin on Infarct Size and Neurologic Outcome After Acute Stroke

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
  • Acute Ischemic Stroke
  • Hyperglycemia
Drug: Insulin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients aged > 18 years presenting to the Emergency Department with symptoms of acute ischemic stroke will be included for study.
  • Acute stroke patients with normal blood glucose levels and patients with fingerstick blood glucose level of greater than or equal to 130 mg/dl will be eligible for study.
  • Acute Stroke will be defined as an acute disturbance of cerebral function of presumed vascular origin causing a neurological deficit of less than 24 hours duration.
  • Patients must have an NIH Stroke Scale Score of 4 to 23. Patients awakening with symptoms of stroke will be considered to have had their stroke at the time when last awake without symptoms.

Exclusion Criteria:

  • Patients presenting after 24 hours of symptom onset. When the actual time of onset is unknown, the time when last observed to be symptom-free will be used.
  • Patients with NIH scale of less than 4 or greater than 23.
  • Complete or substantial resolution of symptoms before randomization.
  • Patients with a previously disabling stroke (modified Rankin score > 3)
  • Patients with other systemic disease such as infection (eg pneumonia, etc)
  • Patients with hemorrhage visualized on CT.
  • Patients who are unwilling or unable to give informed consent, or for whom a legally authorized representative is not able to consent.
  • Pregnant patients.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00373269
3866
No
Nina T. Gentile, M.D., Temple University
Temple University
Not Provided
Principal Investigator: Nina T Gentile, MD Temple University
Temple University
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP