Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke

  • STATUS
    Recruiting
  • End date
    Dec 9, 2022
  • participants needed
    50
  • sponsor
    Milton S. Hershey Medical Center
Updated on 9 May 2022
stroke
ischemic stroke
blood sugar
drug test
pioglitazone
sugars

Summary

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.

Description

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.

Details
Condition Stroke, Acute, Hyperglycemia, Diabetes
Treatment Placebo Oral Tablet, Pioglitazone 45 mg
Clinical Study IdentifierNCT04123067
SponsorMilton S. Hershey Medical Center
Last Modified on9 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Stroke Patients ages 21 and over
Blood sugar ≥ 150 mg/dl
Study drug treatment should be initiated within 12 hours after time of symptom onset, if known, or the time last known normal (if time to symptom onset is unknown)
MRI or CT proven ischemic stroke
Initial NIH SS of ≥ 2
Willing and able to provide consent

Exclusion Criteria

Known hypersensitivity to PGZ
Infection at the time of presentation as defined by body temperature > 38 degrees C , pneumonia evident on chest X-ray, urinary tract infection (positive tests for nitrites, leukocyte esterase, and bacteria on urine analysis), other acute infection per history or current use of antibiotic or antiviral treatment
Active malignancy and / or autoimmune disease requiring treatment
Use of immunomodulatory drugs or chemotherapy
History of stroke or brain injury within the last 90 days prior to presentation
Acute illness within the last 30 days which could have affected the white blood cell count
Known history of clinically significant hypoglycemia
Patients already taking PGZ
Active liver disease (ALT and /or AST 2.5 times the upper limit of normal, total bilirubin > 1.2 mg/dl)
Acute decompensated heart failure, and/or admission for an acute coronary syndrome, myocardial infarction (MI), cardiac arrest, coronary artery surgery within the past 3 months and patients with New York Heart association Class III and IV heart failure
History of bladder cancer
Pregnant and nursing women
Currently incarcerated patients
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