Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone

Study Overview
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Brief Summary
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Primary Aim: To test the acute effects of olanzapine or ziprasidone administration, in comparison to placebo, on insulin sensitivity in antipsychotic-naïve healthy young men, measured as whole-body dextrose infusion rates (mg/kg/min), hepatic glucose production (glucose rate of appearance [Ra]), primarily muscle glucose utilization (glucose rate of disappearance [Rd]), and adipose tissue related free fatty acid production (glycerol rate of appearance [Ra]). We hypothesize that olanzapine, but not ziprasidone, will result in acute decreases in insulin sensitivity. Secondary Aim: To test the acute effects of olanzapine or ziprasidone on insulin signaling pathways in antipsychotic naïve healthy young men. We hypothesize that olanzapine, but not ziprasidone, will result in acute alterations in insulin signaling.

Detailed Description
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See brief description

Official Title
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A Randomized Comparison of the Acute Effects of Olanzapine and Ziprasidone on Whole Body Insulin Sensitivity in Healthy Volunteers

Conditions
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Hyperglycemia, Hyperlipidemia

Intervention / Treatment
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* Drug: Olanzapine
* Drug: Ziprasidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males aged 18-45 years BMI approximately ≥ 25 and < 35 insulin approximately ≥ 15 µU/ml or triglyceride approximately ≥ 130 mg/dl Exclusion Criteria: Any DSM-IV Axis I diagnosis prisoners any serious medical disorder (i.e. metabolic diseases, type 1 or 2 diabetes mellitus, endocrine disease, coagulopathy, clinically significant anemia, acute infection) taking prescription medications non-sedentary lifestyle with > 3 hours of exercise per week

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: olanzapine<br>olanzapine injection in healthy control | Drug: Olanzapine<br>* olanzapine/Zyprexa<br>* Other names: Zyprexa;|
| Active Comparator: ziprasidone<br>ziprasidone injection in healthy control | Drug: Ziprasidone<br>* ziprasidone/Geodon<br>* Other names: Geodon;|
| Placebo Comparator: saline<br>saline injection in healthy control | Drug: Olanzapine<br>* olanzapine/Zyprexa<br>* Other names: Zyprexa;Drug: Ziprasidone<br>* ziprasidone/Geodon<br>* Other names: Geodon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole Body Insulin Sensitivity | To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as whole-body dextrose infusion rates (mg/kg/min). | approximately 3 hours | 
| Hepatic Insulin Sensitivity | To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as hepatic glucose production (glucose rate of appearance [Ra]). | approximately 3 hours | 
| Peripheral Insulin Sensitivity | To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as primarily muscle glucose utilization (glucose rate of disappearance [Rd]). | approximately 3 hours | 
| Adipose Tissue Insulin Sensitivity | To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as free fatty acid release (glycerol rate of appearance [Ra]). | approximately 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy, sedentary, men, acute effects of antipsychotic, blood sugar, insulin sensitivity