Acute brain infarction with type2 diabetes mellitus.
Conditions
Interventions
Intervention: oral administration of pioglitazone 15mg per day.
Control: no use of thiazolidine derivatives.
Sponsors
Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Acute brain infarction (within 7 days after onset). Complicated by type 2 diabetes mellitus. Age equal to or more than 20 years. Ability of oral food intake. Given informed consent to the study.
Exclusion criteria
Exclusion criteria: History of congestive heart failure (in case of suspicious patients, BNP>100 or ejection fraction less than 40%). Administration of thiazolidine derivatives prior to onset. History of adverse reaction to thiazolidine derivatives liver dysfunction (hepatitis due to HBV, HCV, alcohol or increased titer of ALT exceeding 3 times of normal value). Renal dysfunction (Cr>2.5). HbA1c>9%. Requirement for long-term insulin therapy (exclude temporary use of insulin). Brain infarction due to unclassified causes such as dissection, moyamoya disease, etc. Regarded as inadequate to entry for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular events (death, stroke, acute coronary syndrome). Recurrence of brain infarction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of neurological deficits, ADL, cognitive functions, asymptomatic brain lesions, and progression of carotid lesions. Biochemical markers. | — |
Countries
Japan
Outcome results
None listed