Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone

Completed · Not applicable

Conditions studied: Hyperglycemia, Hyperlipidemia

In brief

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.

Key facts

Study ID

NCT00910988

Run by

Washington University School of Medicine

People needed

46

Starts

2009-02-01

Expected to finish

2012-06-01

Last updated by the study team

2018-07-18

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Males aged 18-45 years
• BMI approximately ≥ 25 and < 35
• insulin approximately ≥ 15 µU/ml or triglyceride approximately ≥ 130 mg/dl

You may not qualify if…

• 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

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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