Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone
NCT00910988
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Adult Trials: 18+ Years
- Males aged 18-45 years
- BMI approximately ≥ 25 and < 35
- insulin approximately ≥ 15 µU/ml or triglyceride approximately ≥ 130 mg/dl
- 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
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone | ||||||
| Official Title ICMJE | A Randomized Comparison of the Acute Effects of Olanzapine and Ziprasidone on Whole Body Insulin Sensitivity in Healthy Volunteers | ||||||
| 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 | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single (Participant) Primary Purpose: Prevention | ||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE | 46 | ||||||
| Original Estimated Enrollment ICMJE | 96 | ||||||
| Actual Study Completion Date ICMJE | June 2012 | ||||||
| Actual Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 45 Years (Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT00910988 | ||||||
| Other Study ID Numbers ICMJE | 08-0540 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Washington University School of Medicine | ||||||
| Study Sponsor ICMJE | Washington University School of Medicine | ||||||
| Collaborators ICMJE | Pfizer | ||||||
| Investigators ICMJE |
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| PRS Account | Washington University School of Medicine | ||||||
| Verification Date | June 2018 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||