A Double-blind, Placebo-controlled, Crossover Study Examining the Acute Effects of Olanzapine on Plasma Leptin, Glucose Tolerance and Free Fatty Acids in Healthy Volunteers
Overview
- Phase
- Not Applicable
- Intervention
- Placebo
- Conditions
- Insulin Resistance
- Sponsor
- Milton S. Hershey Medical Center
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Plasma Free Fatty Acid
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this clinical research study is to examine the acute hormonal and metabolic effects of the drug olanzapine, as well as appetite effects, in healthy volunteers. The hypotheses to be tested are that: (1) Olanzapine rapidly attenuates plasma leptin and (2) rapidly alters glucose tolerance in healthy volunteers. These questions will be answered by having volunteers undergo two glucose tolerance tests in a crossover study design.
Investigators
Vance L. Albaugh
MD/PhD Student
Penn State University
Eligibility Criteria
Inclusion Criteria
- •Healthy Volunteer
- •Body Mass Index of 18.5-25 kilograms per square meter
- •Must be able to swallow tablets
- •Able to give informed consent
Exclusion Criteria
- •Any DSM-IV TR Axis I psychiatric disorder (except nicotine dependence)
- •Presence of any medical disorder that may confound the assessment of relevant biologic measures, including: significant organ system dysfunction, metabolic diseases, type 1 diabetes mellitus, type 2 diabetes mellitus, pregnancy, endocrine disease, coagulopathy, clinically significant anemia, or acute infection
- •Subjects who have taken any antipsychotic medication within the last 6 months
- •Personal or family history of seizures and/or cardiac arrhythmias
Arms & Interventions
Placebo
Placebo
Intervention: Placebo
Olanzapine
Olanzapine 10mg po daily x 3 days
Intervention: Olanzapine 10 mg po qhs for 3 days
Outcomes
Primary Outcomes
Plasma Free Fatty Acid
Time Frame: 3 Days
Plasma Free Fatty Acid
Oral Glucose Tolerance
Time Frame: 3 Days
Oral Glucose Tolerance
Plasma Leptin
Time Frame: 3 Days
Leptin following placebo or olanzapine treatment
Secondary Outcomes
- LDL Cholesterol(3 Days)
- BMI(3 Days)
- Diastolic Blood Pressure(3 Days)
- Triglycerides(3 Days)
- HDL Cholesterol(3 Days)
- Systolic Blood Pressure(3 Days)
- Total Cholesterol(3 Days)
- Body Weight(3 Days)
- Heart Rate(3 Days)