N/A Completed N=46 Randomized Single-blind Prevention

Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone

Hyperglycemia · Hyperlipidemia

Source: ClinicalTrials.gov NCT00910988 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2014

Primary outcomePrimary: Whole Body Insulin Sensitivity — 4.9; 5.4; 4.1; 2.9 mg/kg/min — p=0.001

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Whole Body Insulin Sensitivity	4.9; 5.4; 4.1; 2.9; 5.8; 4.7	0.001 sig
PRIMARY Hepatic Insulin Sensitivity	81.0; 79.1; 73.1; 78.5; 84.0; 80.7	—
PRIMARY Peripheral Insulin Sensitivity	152.2; 183.5; 157.0; 83.7; 208.2; 161.0	—
PRIMARY Adipose Tissue Insulin Sensitivity	43.3; 45.2; 52.8; 53.1; 39.5; 37.6	0.57

Eligibility Criteria

Inclusion Criteria

Males aged 18-45 years
BMI approximately ≥ 25 and 3 hours of exercise per week

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00910988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.