search
Back to results

Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone

Primary Purpose

Hyperglycemia, Hyperlipidemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Olanzapine
Ziprasidone
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperglycemia focused on measuring healthy, sedentary, men, acute effects of antipsychotic, blood sugar, insulin sensitivity

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

olanzapine

ziprasidone

saline

Arm Description

olanzapine injection in healthy control

ziprasidone injection in healthy control

saline injection in healthy control

Outcomes

Primary Outcome Measures

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).
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]).
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]).
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]).

Secondary Outcome Measures

Full Information

First Posted
February 3, 2009
Last Updated
June 20, 2018
Sponsor
Washington University School of Medicine
Collaborators
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00910988
Brief Title
Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone
Official Title
A Randomized Comparison of the Acute Effects of Olanzapine and Ziprasidone on Whole Body Insulin Sensitivity in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
See brief description

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Hyperlipidemia
Keywords
healthy, sedentary, men, acute effects of antipsychotic, blood sugar, insulin sensitivity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
olanzapine
Arm Type
Active Comparator
Arm Description
olanzapine injection in healthy control
Arm Title
ziprasidone
Arm Type
Active Comparator
Arm Description
ziprasidone injection in healthy control
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
saline injection in healthy control
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Zyprexa
Intervention Description
olanzapine/Zyprexa
Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Other Intervention Name(s)
Geodon
Intervention Description
ziprasidone/Geodon
Primary Outcome Measure Information:
Title
Whole Body Insulin Sensitivity
Description
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).
Time Frame
approximately 3 hours
Title
Hepatic Insulin Sensitivity
Description
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]).
Time Frame
approximately 3 hours
Title
Peripheral Insulin Sensitivity
Description
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]).
Time Frame
approximately 3 hours
Title
Adipose Tissue Insulin Sensitivity
Description
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]).
Time Frame
approximately 3 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John W Newcomer, MD
Organizational Affiliation
Washington University School of Medicine and Florida Atlantic University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ginger Nicol, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone

We'll reach out to this number within 24 hrs