Study objective is to determine whether Pioglitazone (PGZ) can improve clinical outcomes in hyperglycemic acute ischemic stroke (IS). The rationale for the proposed research is to develop an acute intervention that can improve neurological recovery and decrease mortality and morbidity in high-risk diabetic stroke patients.
This is a prospective, randomized, double blinded stroke intervention study. Patients presenting with hyperglycemia (blood glucose level = or \> than 150mg/dl) and acute stroke symptoms within 12h of onset will be randomized to either treatment with PGZ or placebo. Patients will receive oral drug vs placebo once daily for three consecutive days. Blood samples will be obtained at baseline and during the subsequent three days to collect various biomarkers of the stress-immune response following ischemic stroke. Clinical outcomes (NIH-SS and mRS) will be determined at 3 months. Secondary outcome measures are changes in the various blood biomarkers comparing both study groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1
45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset
placebo daily for three subsequent days, initiated within 12h of stroke symptom onset
Penn State College of Medicine
Hershey, Pennsylvania, United States
Neurological Status
NIH-Stroke scale (0-42) to assess neurological function with 0 being no deficits and 42 being the worst score
Time frame: 90 days post stroke
Degree of Disability or Dependence in the Daily Activities
Measured using the modified Rankin Scale (0-6) to assess neurological function with a score of 0 for no neurological deficits and a maximum of 6 for an expired patient
Time frame: 90 days post stroke
Concentration of Markers of Neutrophil Activation and Function
measured in blood by flow cytometry
Time frame: 24 hours, 48 hours, and 90 days post-stroke
Concentration of Stress Response Markers Including Cortisol, Norepinephrine and Epinephrine
measured in blood
Time frame: 24 hours, 48 hours, and 90 days poststroke
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