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OpenTrials
Completed

NCT Number: NCT00910988

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.

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Key information

Conditions

Hyperglycemia Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Glucose Metabolism Disorders Hyperinsulinism Hyperlipidemia Hyperlipidemias Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Nutritional and Metabolic Diseases Sedentary Behavior

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

See brief description

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine

Drug

olanzapine/Zyprexa

Other names: Zyprexa

Ziprasidone

Drug

ziprasidone/Geodon

Other names: Geodon

Primary outcomes

  1. Whole Body Insulin Sensitivity

    Time frame: approximately 3 hours

    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).

  2. Hepatic Insulin Sensitivity

    Time frame: approximately 3 hours

    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]).

  3. Peripheral Insulin Sensitivity

    Time frame: approximately 3 hours

    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]).

  4. Adipose Tissue Insulin Sensitivity

    Time frame: approximately 3 hours

    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]).

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Pfizer

Registry information

Official study title

A Randomized Comparison of the Acute Effects of Olanzapine and Ziprasidone on Whole Body Insulin Sensitivity in Healthy Volunteers

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 1, 2009
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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