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
  Purpose

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.


Condition Intervention
Acute Ischemic Stroke
Hyperglycemia
Drug: Insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Insulin on Infarct Size and Neurologic Outcome After Acute Stroke

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 133
Study Start Date: January 2004
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373269

Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Nina T Gentile, MD Temple University
  More Information

No publications provided

Responsible Party: Nina T. Gentile, M.D., Temple University
ClinicalTrials.gov Identifier: NCT00373269     History of Changes
Other Study ID Numbers: 3866
Study First Received: September 5, 2006
Last Updated: August 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
Acute ischemic stroke
Stroke
Hyperglycemia
Insulin
Progoagulation
Diabetes
Blood coagulation

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Hyperglycemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014