Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Antipsychotic Drugs in Healthy Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- To determine the effect of subchronic olanzapine and haloperidol treatment on HGO, whole body peripheral glucose disposal, fatty acid flux and fuel oxidation.
研究概览
简要总结
We hypothesized that short-term treatment with AP drugs induces insulin resistance through a mechanistic route that is independent of weight gain and that atypical drugs exert stronger effects than typical compounds in this respect. We therefore treated healthy non-obese men with olanzapine (atypical AP) or haloperidol (typical AP) for 8 days, and studied the impact of these interventions on glucose and lipid metabolism by hyperinsulinemic euglycemic clamp, isotope dilution technology and indirect calorimetry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men, with and without a positive family history of schizophrenia.
- •20 kg/m2 < BMI < 26 kg/m2
- •Age 20-40 years
- •Fasting plasma glucose < 6 mmo/L
排除标准
- •FPG > 6 mmol/L
- •BMI > 26 kg/m2
- •Psychiatric disorders and/or use of antipsychotic or antidepressants drugs at present or in the past.
- •Any significant chronic disease
- •Renal, hepatic or endocrine disease
- •Use of medication known to influence lipolysis and/or glucose metabolism
- •Total cholesterol > 7mmol/L and/or triglycerides > 2 mmol/L
- •Recent weight changes or attempts to loose weight (> 3 kg weight gain or loss, within the last 3 months)
- •Difficulties to insert an intravenous catheter
- •Smoking (current)
- •Severe claustrophobia (ventilated hood)
- •Recent blood donation (within the last 2 months)
- •Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
- •Extensive sporting activities (more than 10 hours of exercise per week)
研究组 & 干预措施
1
Healthy men
干预措施: olanzapine (Drug)
2
Healthy men with a positive family anamneses of schizophrenia
干预措施: olanzapine (Drug)
2
Healthy men with a positive family anamneses of schizophrenia
干预措施: Haloperidol (Drug)
结局指标
主要结局
To determine the effect of subchronic olanzapine and haloperidol treatment on HGO, whole body peripheral glucose disposal, fatty acid flux and fuel oxidation.
时间窗: 8 days
次要结局
未报告次要终点