Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||A Randomized Comparison of the Acute Effects of Olanzapine and Ziprasidone on Whole Body Insulin Sensitivity in Healthy Volunteers|
- blood sugar [ Time Frame: approximately 8 hours ] [ Designated as safety issue: No ]
- insulin sensitivity and signaling [ Time Frame: approximately 8 hours ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
240 ml of blood
|Study Start Date:||February 2009|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||John W Newcomer, MD||Washington University School of Medicine|
|Principal Investigator:||Ginger Nicol, MD||Washington University School of Medicine|