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临床试验/NCT01496183
NCT01496183已完成不适用

Metabolic Effects of Olanzapine in Healthy Males

State University of New York at Buffalo1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2007年10月最近更新:
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steven Dubovsky

principal investigator

State University of New York at Buffalo

研究点 (1)

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Metabolic Effects of Olanzapine in Healthy Males | 临床试验