Pioglitazone as a Treatment for Lipid and Glucose Abnormalities In Patients With Schizophrenia
Condition: Diabetes; Schizophrenia; Insulin Resistance; Cognitive Impairment
MeSH terms: Insulin Resistance; Schizophrenia
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      The aim of this study is to investigate the effects of pioglitazone added to weight-lifestyle
      intervention vs. placebo plus lifestyle intervention on reversing or reducing impaired or
      abnormal triglycerides, HDL and glucose metabolism in schizophrenics treated with first or
      second-generation antipsychotics.. Another aim is to examine the effects of impaired glucose
      metabolism on verbal memory and other cognitive function in schizophrenic patients treated
      with these medications and the relationship to improvements in impaired glucose metabolism to
      impairments in cognitive function. Clozapine and olanzapine, and some other first or
      second-generation antipsychotics effective for treating schizophrenia and bipolar disorders,
      have been reported to be associated with increased incidence of diabetic type metabolic
      abnormalities, decreases in insulin sensitivity, and abnormal glucose tolerance tests. This
      can lead to the development of type 2 diabetes and also abnormal lipid metabolic levels which
      can lead to atherosclerotic changes and increased risk of cardiovascular disease and other
      diabetes related complications. Drug treatments which could reduce or correct these diabetic
      metabolic changes would permit many patients to continue to receive the benefits of these
      antipsychotic medications with reduced drug-induced comorbidity. Previous research using
      non-psychotic subjects has shown that diabetes and impaired glucose tolerance are associated
      with cognitive impairments, especially in verbal memory, and provides a rationale for testing
      whether corrections of impaired glucose metabolism are associated with cognitive improvements
      in schizophrenic patients.
    

Intervention name(s): Pioglitazone; Life style diet group; Placebo
Intervention type(s): Drug; Behavioral; Other
Intervention description(s): pioglitazone 30-45 mg/day; life style diet education group 1x/week; placebo comparator capsules
Other intervention name(s): Actos
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: atypical antipsychotics; hyperglycemia; triglycerides; HDL; cholesterol; insulin resistance; schizophrenia; verbal memory