Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke

Diabetes Clinical Trial

Official title:

Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke: Effects on the Stress-Immune Response

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04123067
• Other study ID #: 00011042
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: September 1, 2020
• Est. completion date: April 7, 2021

Study information

• Verified date: August 2022
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 7, 2021
• Est. primary completion date: April 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Stroke Patients ages 21 and over

2. Blood sugar = 150 mg/dl

3. 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)

4. MRI or CT proven ischemic stroke

5. Initial NIH SS of = 2

6. Willing and able to provide consent

Exclusion Criteria:

1. Known hypersensitivity to PGZ.

2. 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.

3. Active malignancy and / or autoimmune disease requiring treatment.

4. Use of immunomodulatory drugs or chemotherapy.

5. History of stroke or brain injury within the last 90 days prior to presentation.

6. Acute illness within the last 30 days which could have affected the white blood cell count.

7. Known history of clinically significant hypoglycemia.

8. Patients already taking PGZ.

9. Active liver disease (ALT and /or AST 2.5 times the upper limit of normal, total bilirubin > 1.2 mg/dl).

10. 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.

11. History of bladder cancer

12. Pregnant and nursing women.

13. Currently incarcerated patients.

Related Conditions & MeSH terms

• Diabetes
• Hyperglycemia
• Ischemic Stroke
• Stroke
• Stroke, Acute

Intervention

Drug:
• Pioglitazone 45 mg
45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset
• Placebo oral tablet
placebo daily for three subsequent days, initiated within 12h of stroke symptom onset

Locations

Country	Name	City	State
United States	Penn State College of Medicine	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological Status	NIH-Stroke scale (0-42) to assess neurological function with 0 being no deficits and 42 being the worst score	90 days post stroke
Primary	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	90 days post stroke
Secondary	Concentration of Markers of Neutrophil Activation and Function	measured in blood by flow cytometry	24 hours, 48 hours, and 90 days post-stroke
Secondary	Concentration of Stress Response Markers Including Cortisol, Norepinephrine and Epinephrine	measured in blood	24 hours, 48 hours, and 90 days poststroke