Status:
COMPLETED
Pioglitazone as a Treatment for Lipid and Glucose Abnormalities In Patients With Schizophrenia
Lead Sponsor:
Nathan Kline Institute for Psychiatric Research
Conditions:
Diabetes
Schizophrenia
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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...
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 triglyc...
Eligibility Criteria
Inclusion
- Patients will be males or females, 18-70 yrs of age, with a diagnosis of schizophrenia or schizoaffective disorder, and currently being treated with olanzapine or clozapine.
- Patients will have evidence of:
- glucose levels indicating at least impaired fasting glucose: fasting glucose 100 mg/dL or 2 hr glucose tolerance test 140 mg/dL, or current treatment with oral antidiabetic drugs with history of hyperglycemia;
- Triglyceride levels \> 120 mg/dL and/or HDL levels \< 40 mg/dL
Exclusion
- Diabetes mellitus, type 1
- Recent diabetic ketoacidosis;
- Patients not currently treated with oral antidiabetic drugs but fasting is glucose 140 mg/dL \[WHO criteria\] on repeat testing in last three months, or random blood glucose \>200 mg/dL plus 2 hr glucose on GTT \>200 mg/dL; (these patients may need more immediate treatment with antidiabetic drugs and it is less certain if weight-lifestyle treatment would be effective in treating such high glucose levels);
- Patients with active liver disease with clinical abnormalities which need current treatment, or liver enzymes (Alt) 3 times upper limit for normal values in chart records in last year, or patients who are recorded as positive for hepatitis C;
- Congestive heart failure (Class III or IV cardiac status) or history of MI in medical record (because pioglitazone can increase blood volume slightly);
- Hematocrit greater than 10% below normal (hematocrit may be decreased 2 to 4% due to increased plasma volume);
- Female patients on current oral contraceptives (because pioglitazone may interfere with effects of some oral contraceptives);
- Patients taking ketoconazole,
- Patients who have started on atorvastatin or gemfibrozil in the past 2 months or have had a dose increase in atorvastatin in the last month (since these drugs can also lower triglycerides and raise HDL, recent start of therapy with these drugs could be a confound).
- Patients are not concomitantly treated with aripiprazole or ziprasidone.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00231894
Start Date
May 1 2005
End Date
January 1 2010
Last Update
December 11 2017
Active Locations (1)
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1
Nathan Kline Institute for Psychiatric Research
New York, New York, United States, 10035