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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Plasma Free Fatty Acid
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteer
- •Body Mass Index of 18.5-25 kilograms per square meter
- •Must be able to swallow tablets
- •Able to give informed consent
排除标准
- •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
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
Olanzapine
Olanzapine 10mg po daily x 3 days
干预措施: Olanzapine 10 mg po qhs for 3 days (Drug)
结局指标
主要结局
Plasma Free Fatty Acid
时间窗: 3 Days
Plasma Free Fatty Acid
Oral Glucose Tolerance
时间窗: 3 Days
Oral Glucose Tolerance
Plasma Leptin
时间窗: 3 Days
Leptin following placebo or olanzapine treatment
次要结局
- 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)
研究者
Vance L. Albaugh
MD/PhD Student
Penn State University