Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287820
Status:
COMPLETED
Last Update Posted:
2011-07-25
First Post:
2006-02-06
Brief Title:
Comparative Effects of Chronic Treatment With Olanzapine and Risperidone on Glucose and Lipid Metabolism
Sponsor:
Nathan Kline Institute for Psychiatric Research
Organization:
Nathan Kline Institute for Psychiatric Research
Study Overview
Official Title:
Independent Investigator Grant Study-Comparative Effects of Chronic Treatment With Olanzapine and Risperidone on Glucose and Lipid Metabolism
Status:
COMPLETED
Status Verified Date:
2007-12
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:
The primary objective of the study is to assess whether chronic treatment with olanzapine over a five-month period produces a significant increase in abnormalities in glucose levels The main secondary objective is to evaluate whether the increase in glucose levels and rate of glucose abnormalities differs between Olanzapine and Risperidone during this treatment period Additional secondary objectives of the study are to investigate similar questions with respect to glycohemoglobin triglycerides and other measures of glucose and lipid metabolism
We hypothesize that Olanzapine will not be inferior to Risperidone in extent of increase in the primary outcome measure of serum glucose and secondary measures of glycohemoglobin insulin and lipids
We hypothesize that Olanzapine will not be inferior to Risperidone in extent of increase in the primary outcome measure of serum glucose and secondary measures of glycohemoglobin insulin and lipids
Detailed Description:
In the on-going study in progress we use an extensive battery of assessments to investigate afasting levels of glucose and lipids at baseline and monthly during 5 months of treatment b glucose tolerance tests to investigate glucose and insulin abnormalities after a glucose load at baseline and during study treatment and cthe effects of treatment with olanzapine and risperidone of post prandial glucose metabolism after a fatty meal as detailed in the body of the proposal Recent studies have shown that increased postprandial lipidemia is an important feature of many patients with type 2 diabetes and atherosclerosis In addition to the biochemical measures we will also assess clinical effects PANSS and CGI ratings and other side-effects weight gain appetite somnolence and EPS and TD The specific plan calls for inpatients in a tertiary care hospital to be randomly assigned to olanzapine or risperidone using a stratified random assignment procedure and treated for five months with either olanzapine or risperidone We estimate that we will have to enroll a sample of approximately 50-55 patients to obtain 46 acceptable complete casesas specified in proposal below On the basis of preliminary results from our prior and ongoing studies we predict no significant increase in glucose abnormalities from baseline during chronic treatment with olanzapine and no significant differences in development of glucose abnormalities in patients in patient treated with olanzapine and risperidone
Additional measures being investigated include comparison of olanzapine and risperidone in glucose and lipid responses to a fatty meal ghrelin changes in response to a fatty mean and CRP and IL-6 and thyroid and prolactin response to five months of treatment with the two drugs
Additional measures being investigated include comparison of olanzapine and risperidone in glucose and lipid responses to a fatty meal ghrelin changes in response to a fatty mean and CRP and IL-6 and thyroid and prolactin response to five months of treatment with the two drugs
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