Clinical trial · Interventional
Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone
A Randomized Comparison of the Acute Effects of Olanzapine and Ziprasidone on Whole Body Insulin Sensitivity in Healthy Volunteers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hyperglycemia | — | UNRESOLVED | — |
| Hyperlipidemia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Olanzapine | Drug | — | UNRESOLVED |
| Ziprasidone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- olanzapine
- description
- olanzapine injection in healthy control
- interventionNames
- Drug: Olanzapine
- type
- ACTIVE_COMPARATOR
- label
- ziprasidone
- description
- ziprasidone injection in healthy control
- interventionNames
- Drug: Ziprasidone
- type
- PLACEBO_COMPARATOR
- label
- saline
- description
- saline injection in healthy control
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available