NCT02708394已完成早期 1 期
Molecular Mechanisms of Antipsychotic-induced Insulin Resistance in Healthy Volunteers
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change in DNA methylation
研究概览
简要总结
This study will investigate the molecular mechanisms of atypical-antipsychotic induced insulin resistance. This will be accomplished by administering olanzapine or placebo to healthy subjects for 7 days and analyzing genetic and protein changes in peripheral tissues known to play an important role in insulin resistance pathophysiology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
olanzapine
Experimental
Atypical antipsychotic
干预措施: olanzapine (Drug)
placebo
Placebo Comparator
Placebo comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change in DNA methylation
时间窗: Baseline (day 1) to endpoint of intervention (day 7)
Change in peripheral tissue candidate gene methylation will be measured in the olanzapine intervention group compared to placebo
次要结局
- Change in protein activity(Baseline (day 1) to endpoint of intervention (day 7))
- Change in protein levels(Baseline (day 1) to endpoint of intervention (day 7))
研究者
Kyle Jon Burghardt, Pharm.D.
Assistant Professor
Wayne State University
研究点 (1)
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