NCT01496183已完成不适用
Metabolic Effects of Olanzapine in Healthy Males
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change From Baseline in Weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteer
- •Aged 18-35 years
- •Body Mass Index (BMI): <30 kg/m2
排除标准
- •Presence of any medical disorder that may confound the assessment of relevant biological measures
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Olanzapine
Experimental
干预措施: Olanzapine (Drug)
结局指标
主要结局
Change From Baseline in Weight
时间窗: Assessed at baseline and 2 weeks
次要结局
- Change From Baseline in Body Composition(baseline and 2 weeks of treatment (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))
- Change From Baseline in Resting Metabolic Rate(baseline and 2weeks of treatment)
- Change From Baseline Triglycerides(Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo))
- Change From Baseline in Glucose(Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo))
- Change From Baseline in Leptin(Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo))
- Change From Baseline in Insulin(Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo))
- Change From Baseline Total Cholesterol(baseline and 2 weeks treatment)
- LDL(baseline and 2 weeks treatment)
- HDL(baseline and 2 weeks treatment)
- Physical Activity as Measured Using a Physical Activity Monitor(baseline and 2 week treatment)
研究者
Steven Dubovsky
principal investigator
State University of New York at Buffalo
研究点 (1)
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