Characterization of Insulin Action and Dopamine-signaling in the Human Brain of Normal Weight and Obese Subjects by [11C]-Raclopride-PET/MRT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Effects of nasal insulin vs. placebo on the insulin sensitivity of the human brain as well as effects on regional availability of dopamine receptors.
研究概览
简要总结
Cerebral insulin resistance plays an important role in the development of obesity and diabetes mellitus type 2. The aim of this project is to examine the effect of human nasal insulin on the dopaminergic system. Therefore, characteristics of cerebral dopamine receptors before and after administration of nasal insulin vs. placebo shall be analyzed in a randomized way. Moreover, the investigators plan to examine the insulin action on cortical and subcortical activation in humans and the interaction of dopamine metabolism with [11C]-Raclopride-PET/MRI. By performing fMRI measurements, insulin sensitivity of the central nervous system can be investigated simultaneously. Recruiting is planed as a two-step process.First 12 normal-weight (BMI 20-25 kg/m²) men should be examined. If first results show a insulin-dependent effect on the availability of dopamine receptors in the human brain, recruitment of 12 overweight men will get started.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
- •Intake of any medication
- •HbA1C <6%
- •BMI 20-25 kg/m²
- •Clinical routine blood parameters within the normal ranges
- •All participants must agree to get informed of unexpected detected, clinical relevant findings.
排除标准
- •Acute diseases such as infections (e.g.)
- •Any relevant cardiovascular disease
- •Any surgery within the last three months
- •Any neurologic or psychiatric disease
- •Known allergies
- •Hb < 13 g/dl
- •Presence of any contraindication for the conduct of an MRI investigation, such as cardiac pacemakers, ferromagnetic haemostatic clips in the central nervous system, metallic splinters in the eye, ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators, cochlear implants, insulin pumps and nerve stimulators, prosthetic heart valves etc.
- •Claustrophobia
结局指标
主要结局
Effects of nasal insulin vs. placebo on the insulin sensitivity of the human brain as well as effects on regional availability of dopamine receptors.
时间窗: 0-60 min
assessed by fMRI (insulin sensitivity of the brain measured as change in regional brain activity and Raclopride-PET/MRT (regional dopamine receptor availability).
次要结局
- Effects of nasal insulin vs. placebo on changes in plasma insulin levels(0 - 60min)
- Effects of nasal insulin vs. placebo on changes in FFA levels(0 - 60min)
- Effects of nasal insulin vs. placebo on changes in plasma glucose levels(0 - 60min)
- Effects of nasal insulin vs. placebo on changes in autonomic nervous system(-30 - 60 min)
- Differences between normalweight and overweight subjects regarding insulin sensitivity and availability of dopamine receptors(0 - 60 min)
- Effects of nasal insulin vs. placebo on changes in prolactin levels as a proxy for the dopaminergic tonus(0 - 60min)