HyperglycemiaNCT00910988
Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone
A study testing Olanzapine and Ziprasidone in people with Hyperglycemia and Hyperlipidemia, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia, Hyperlipidemia
- What is being tested?
- Olanzapine and Ziprasidone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jun 2012
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males aged 18-45 years
- BMI approximately ≥ 25 and < 35
- insulin approximately ≥ 15 µU/ml or triglyceride approximately ≥ 130 mg/dl
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Randomized Comparison of the Acute Effects of Olanzapine and Ziprasidone on Whole Body Insulin Sensitivity in Healthy Volunteers
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.
Read more
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.
Read the detailed description
See brief description
- Conditions
- Hyperglycemia, Hyperlipidemia
- Being tested
- Olanzapine, Ziprasidone
- Keywords
- healthy, sedentary, men, acute effects of antipsychotic, blood sugar, insulin sensitivity
- Medical subject headings
- Hyperglycemia, Hyperlipidemias, Sedentary Behavior, Multiple Endocrine Neoplasia Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Also called Zyprexa
olanzapine/Zyprexa
ZiprasidoneDrug
Also called Geodon
ziprasidone/Geodon
| Study group | Role | What they receive |
|---|---|---|
| olanzapine | Active comparator | olanzapine injection in healthy control Receives: Drug: Olanzapine |
| ziprasidone | Active comparator | ziprasidone injection in healthy control Receives: Drug: Ziprasidone |
| saline | Placebo comparator | saline injection in healthy control Receives: Drug: Olanzapine; Drug: Ziprasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: approximately 3 hours
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]).
Measured: approximately 3 hours
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]).
Measured: approximately 3 hours
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]).
Measured: approximately 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- John W Newcomer, MD, Principal investigator, Washington University School of Medicine and Florida Atlantic UniversityGinger Nicol, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910988
- Sponsor's protocol ID
- 08-0540
- Status last verified
- Aug 2026
- First submitted
- 3 Feb 2009
- Last updated
- 4 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No