Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone

Hyperlipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910988
• Other study ID #: 08-0540
• Status: Completed
• Phase: N/A
• Start date: February 2009
• Est. completion date: June 2012

Study information

• Verified date: June 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See brief description

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperglycemia
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias
• Insulin Resistance

Intervention

Drug:
• Olanzapine
olanzapine/Zyprexa
• Ziprasidone
ziprasidone/Geodon

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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