Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00205725
Status:
COMPLETED
Last Update Posted:
2014-03-13
First Post:
2005-09-13
Brief Title:
PfizerIVGTTZiprasidoneOlanzapine
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Glucose Regulation During Ziprasidone Treatment
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Abnormalities in peripheral glucose regulation and type 2 diabetes can occur more commonly in individuals with schizophrenia than in healthy subjects or in other psychiatric conditions Antipsychotic treatment may contribute significantly to abnormalities in glucose regulation Hyperglycemia can contribute to long-term cardiovascular disease risk that may already be increased in patients with schizophrenia due to higher rates of smoking sedentary life style obesity and under-treated hypertension and dyslipidemia This project will characterize the effects on glucose control of the two most commonly prescribed newer antipsychotic medications ziprasidone and olanzapine in patients with schizophrenia
Detailed Description:
This proposal aims to use a well-characterized procedure the modified Frequently Sampled Intravenous Glucose Tolerance Test FSIGTT to characterize the glucoregulatory effects of the two most commonly prescribed atypical antipsychotic medications ziprasidone and olanzapine in comparison to the conventional antipsychotic haloperidol Abnormalities in peripheral glucose regulation and type 2 diabetes can occur more commonly in individuals with schizophrenia than in healthy subjects or in other psychiatric conditions While abnormalities in glucose regulation were first reported in schizophrenia prior to the introduction of antipsychotic medications antipsychotic treatment may contribute significantly to abnormalities in glucose regulation
Recently the adverse effect of antipsychotic medications on systemic glucose regulation has received increased attention as investigators noted prominent adverse glucoregulatory effects associated with certain newer antipsychotic medications Abnormal glucose regulation and new-onset type 2 diabetes have been reported during clozapine and olanzapine treatment Complicating the study of antipsychotic-induced changes in glucose regulation increased adiposity can decrease insulin sensitivity and antipsychotics can increase adiposity and body mass index BMI However abnormal glucose regulation and type 2 diabetes can occur during clozapine treatment in the absence of weight gain suggesting that changes in glucose regulation can occur independent of drug-induced increases in BMI Consistent with this our preliminary studies indicate that important effects of clozapine and olanzapine on glucose regulation are not accounted for by differences in BMI This proposal will compare the effects of olanzapine ziprasidone and haloperidol on well-defined measures of glucose regulation
This proposal specifically hypothesizes that olanzapine treatment will be associated with decreases in insulin sensitivity SI without effects on insulin secretion Treatment-related effects on glucose effectiveness SG will be explored
Recently the adverse effect of antipsychotic medications on systemic glucose regulation has received increased attention as investigators noted prominent adverse glucoregulatory effects associated with certain newer antipsychotic medications Abnormal glucose regulation and new-onset type 2 diabetes have been reported during clozapine and olanzapine treatment Complicating the study of antipsychotic-induced changes in glucose regulation increased adiposity can decrease insulin sensitivity and antipsychotics can increase adiposity and body mass index BMI However abnormal glucose regulation and type 2 diabetes can occur during clozapine treatment in the absence of weight gain suggesting that changes in glucose regulation can occur independent of drug-induced increases in BMI Consistent with this our preliminary studies indicate that important effects of clozapine and olanzapine on glucose regulation are not accounted for by differences in BMI This proposal will compare the effects of olanzapine ziprasidone and haloperidol on well-defined measures of glucose regulation
This proposal specifically hypothesizes that olanzapine treatment will be associated with decreases in insulin sensitivity SI without effects on insulin secretion Treatment-related effects on glucose effectiveness SG will be explored
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None