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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373269
• Other study ID #: 3866
• Status: Completed
• Phase: N/A
• First received: September 5, 2006
• Last updated: April 10, 2015
• Start date: January 2004
• Est. completion date: January 2010

Study information

• Verified date: April 2015
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Hyperglycemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Insulin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in infarct volume at Week 1 from baseline as measured on diffusion - perfusion magnetic resonance imaging		baseline to one week	No
Primary	Analyses of group mean infarct volume and the mean percent change from baseline to Week 1		baseline to one week	No
Secondary	Blood sugar		hour 0.25, 0.5, 1, 2,4,6,8,12,16,20,24, 36, 48	Yes
Secondary	Coagulation Studies		hour 0, 6,12,24,48	No
Secondary	Neurological Assessment: NIHSS, Barthel Index, Modified Rankin Score		hr 0, 48, week 1 and week 12	No
Secondary	Mortality rates		hour 0 to one week	Yes