Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone

Not Applicable

Completed

• Conditions: Hyperglycemia; Hyperlipidemia
• Interventions: Drug: Olanzapine; Drug: Ziprasidone

• Registration Number: NCT00910988
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

See brief description

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-03
• Study First Submitted QC: 2009-05-28
• Study First Posted: 2009-06-01
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2013-04-11
• Results First Submitted QC: 2013-11-26
• Results First Posted: 2014-01-15
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-20
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
olanzapine	Olanzapine	olanzapine injection in healthy control
ziprasidone	Ziprasidone	ziprasidone injection in healthy control
saline	Olanzapine	saline injection in healthy control
saline	Ziprasidone	saline injection in healthy control

Primary Outcome Measures

Name	Time	Method
Hepatic Insulin Sensitivity	approximately 3 hours	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 \[Ra\]).
Whole Body Insulin Sensitivity	approximately 3 hours	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).
Peripheral Insulin Sensitivity	approximately 3 hours	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 \[Rd\]).
Adipose Tissue Insulin Sensitivity	approximately 3 hours	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 \[Ra\]).

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States