Effects of the Serotonin 2A Receptor on Insulin Sensitivity and Secretion: a Double-blind Controlled Comparison of Olanzapine vs. Amisulpride:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- insulin sensitivity
研究概览
简要总结
Patients suffering from schizophrenia have a high risk to become obese and develop diabetes. Risk of obesity is particularly high with some newer schizophrenia drugs, such as clozapine or olanzapine. These drugs are called atypical drugs and exert their action in part by occupying receptors for serotonin, particularly the 5HT2A receptor subtype. This receptor may also interfere with glucose metabolism and insulin action. The purpose of this study is to compare an atypical antipsychotic drugs, olanzapine, which acts by occupying the 5HT2A receptor, to another antipsychotic drug, amisulpride, which mainly acts through the dopamine pathway. Healthy volunteers are recruited and asked to take a single dose of each drug and of placebo on separate days. Then, a combined glucose clamp study will be performed in order to test the effects of these drugs on insulin sensitivity and insulin secretion.
详细描述
10 male healthy volunteers are recruited. After informed consent, they are admitted to the study ward at 10:00 p.m. prior to the study day and kept fasting until the next morning. At 8:00 a.m. they receive their study medication (olanzapine, amisulpride or placebo). Subsequently, measurements of insulin sensitivity and insulin secretion are performed by euglycemic hyperinsulinemic clamp technique followed by hyperglycemic clamp.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male volunteers
- •written informed consent
排除标准
- •BMI > 30 kg/m²
- •Diabetes mellitus
- •Hypertension
- •Treatment with drugs interfering with lipid or glucose metabolism (e.g. statins, oral antidiabetic drugs, glucocorticoids)
- •History of seizures
研究组 & 干预措施
Amisulpride
Single dose of amisulpride 200 mg p.o. given at 8:00 a.m.
干预措施: Glucose clamp technique (Procedure)
Amisulpride
Single dose of amisulpride 200 mg p.o. given at 8:00 a.m.
干预措施: Amisulpride (Drug)
Olanzapine
Single dose of olanzapine 10 mg p.o. given at 8:00 a.m.
干预措施: Glucose clamp technique (Procedure)
Olanzapine
Single dose of olanzapine 10 mg p.o. given at 8:00 a.m.
干预措施: Olanzapine (Drug)
Placebo
Placebo capsules are given at 8:00 a.m. Procedures are performed as described above.
干预措施: Glucose clamp technique (Procedure)
Placebo
Placebo capsules are given at 8:00 a.m. Procedures are performed as described above.
干预措施: Placebo (Drug)
结局指标
主要结局
insulin sensitivity
时间窗: 90 thru 120 min after application of study drug
m-value during euglycemic glucose clamp (glucose infusion rate divided by time and body weight)
次要结局
- pancratic c-peptide secretion(120 thru 180 minutes after administration of study drug)