A Randomized Comparison of the Acute Effects of Olanzapine and Ziprasidone on Whole Body Insulin Sensitivity in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Hepatic Insulin Sensitivity
研究概览
简要总结
Primary Aim: To test the acute effects of olanzapine or ziprasidone administration, in comparison to placebo, on insulin sensitivity in antipsychotic-naïve healthy young men, measured as whole-body dextrose infusion rates (mg/kg/min), hepatic glucose production (glucose rate of appearance [Ra]), primarily muscle glucose utilization (glucose rate of disappearance [Rd]), and adipose tissue related free fatty acid production (glycerol rate of appearance [Ra]).
We hypothesize that olanzapine, but not ziprasidone, will result in acute decreases in insulin sensitivity.
Secondary Aim: To test the acute effects of olanzapine or ziprasidone on insulin signaling pathways in antipsychotic naïve healthy young men.
We hypothesize that olanzapine, but not ziprasidone, will result in acute alterations in insulin signaling.
详细描述
See brief description
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males aged 18-45 years
- •BMI approximately ≥ 25 and < 35
- •insulin approximately ≥ 15 µU/ml or triglyceride approximately ≥ 130 mg/dl
排除标准
- •Any DSM-IV Axis I diagnosis
- •prisoners
- •any serious medical disorder (i.e. metabolic diseases, type 1 or 2 diabetes mellitus, endocrine disease, coagulopathy, clinically significant anemia, acute infection)
- •taking prescription medications
- •non-sedentary lifestyle with > 3 hours of exercise per week
研究组 & 干预措施
olanzapine
olanzapine injection in healthy control
干预措施: Olanzapine (Drug)
saline
saline injection in healthy control
干预措施: Ziprasidone (Drug)
ziprasidone
ziprasidone injection in healthy control
干预措施: Ziprasidone (Drug)
saline
saline injection in healthy control
干预措施: Olanzapine (Drug)
结局指标
主要结局
Hepatic Insulin Sensitivity
时间窗: approximately 3 hours
To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as hepatic glucose production (glucose rate of appearance \[Ra\]).
Whole Body Insulin Sensitivity
时间窗: approximately 3 hours
To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as whole-body dextrose infusion rates (mg/kg/min).
Peripheral Insulin Sensitivity
时间窗: approximately 3 hours
To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as primarily muscle glucose utilization (glucose rate of disappearance \[Rd\]).
Adipose Tissue Insulin Sensitivity
时间窗: approximately 3 hours
To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as free fatty acid release (glycerol rate of appearance \[Ra\]).
次要结局
未报告次要终点