At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of schizophrenia or schizoaffective disorder
- ✓Currently treated with olanzapine or clozapine
- ✓Age 18-70 years
- ✓Evidence of impaired glucose metabolism: fasting glucose ≥100 mg/dL, or 2-hour glucose tolerance test ≥140 mg/dL, or current oral antidiabetic treatment with hyperglycemia history
- ✕Type 1 diabetes mellitus
- ✕Recent diabetic ketoacidosis
- ✕Severe untreated hyperglycemia: fasting glucose ≥140 mg/dL (not on antidiabetics) on repeat testing in last 3 months, or random blood glucose >200 mg/dL plus 2-hour GTT >200 mg/dL
- ✕Active liver disease requiring treatment, or ALT ≥3× upper limit of normal in past year, or positive for hepatitis C
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pioglitazone as a Treatment for Lipid and Glucose Abnormalities In Patients With Schizophrenia Treated With Antipsychotic Medication And Potential Effects on Cognitive Function
In Brief
A Phase 4 clinical trial evaluating Pioglitazone, Life style diet group, and 1 other intervention for Diabetes and 3 related conditions. Completed, enrolled 56 participants across 1 site.
Detailed Summary
This is a study with an approved drug for treating type 2 diabetes, for its effects on treating glucose and lipid abnormalities in patients being treated with first or second-generation antipsychotics, and comparison of effects of this drug with another treatment lifestyle modification. Patients who meet inclusion criteria will be treated with pioglitazone for 12 weeks. They will be evaluated for fasting glucose and lipids, glucose-tolerance tests, and neurocognitive battery and tests of verbal memory at baseline and during treatment with pioglitazone.
Study Details
Timeline
Interventions
pioglitazone 30-45 mg/day
life style diet education group 1x/week
placebo comparator capsules