Metabolic Effects of Olanzapine in Healthy Males
- Registration Number
- NCT01496183
- Lead Sponsor
- State University of New York at Buffalo
- Brief Summary
The purpose of this study is to look at how a two-week use of a medication called Olanzapine might change appetite, physical activity, resting metabolic rate, body composition, and weight in healthy men.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
- Healthy Volunteer
- Male
- Aged 18-35 years
- Body Mass Index (BMI): <30 kg/m2
- Presence of any medical disorder that may confound the assessment of relevant biological measures
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Olanzapine Olanzapine -
- Primary Outcome Measures
Name Time Method Change From Baseline in Weight Assessed at baseline and 2 weeks
- Secondary Outcome Measures
Name Time Method Change From Baseline in Body Composition baseline and 2 weeks of treatment (olanzapine or placebo) lean body mass (kg) and fat mass (kg) at baseline and after 2 weeks of treatment with olanzapine or placebo
Change From Baseline in 24-Hour Dietary Recall Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) 24-hour dietary intake recall at baseline and after 2 weeks of treatment with olanzapine or placebo
Change From Baseline in Resting Metabolic Rate baseline and 2weeks of treatment Resting metabolic rate at baseline and after 2 weeks of treatment
Change From Baseline Triglycerides Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) Triglycerides (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo
Change From Baseline in Glucose Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) Glucose (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo
Change From Baseline in Leptin Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) Leptin (ng/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo
Change From Baseline in Insulin Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) Insulin (µIU/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo
Change From Baseline Total Cholesterol baseline and 2 weeks treatment Total cholesterol at baseline and after 2 weeks treatment with olanzapine or placebo
LDL baseline and 2 weeks treatment Low-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo
HDL baseline and 2 weeks treatment High-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo
Physical Activity as Measured Using a Physical Activity Monitor baseline and 2 week treatment Change from baseline in physical activity. Physical activity was measured using an activity monitor that subjects wore around their waist throughout baseline and treatment days. Subjects were instructed to remove the monitor when sleeping or engaging in water-based activities, and to report on a daily log the times that they were wearing and removing the device. Physical activity was monitored during weekdays and weekend days. Physical activity data were collected in 60-second epochs. The results are reported as average counts per day of physical activity for weekdays and weekend days at baseline and 2 week treatment.
Trial Locations
- Locations (1)
Department of Psychiatry, The State University of New York at Buffalo
🇺🇸Buffalo, New York, United States