Effekte Der Transkutanen Aurikularen Vagus-Nervenstimulation (tVNS) Auf Die Postprandiale Stoffwechselregulation im Menschen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Whole body insulin sensitivity
研究概览
简要总结
Two important mechanisms play a major role in the pathogenesis of type 2 diabetes: insulin resistance of the target tissues and the impaired insulin secretion from pancreatic β-cells. Postprandial factors (such as insulin) are perceived by the human brain and induce signals that regulate glucose metabolism via the parasympathetic nervous system.
Transcutaneous auricular vagus nerve stimulation (tVNS) can be used on the outer ear to stimulate the auricular branch of the vagus nerve in humans. Heart rate variability (HRV) in healthy people can be significantly increased via tVNS, indicating a shift from sympathetic activity to parasympathetic activity.
The hypothesis is that this postprandial shift results in a change in peripheral glucose metabolism. In turn, the increased parasympathetic activity could potentially result in a change in postprandial insulin sensitivity or secretion.
To test this hypothesis, this study investigates the effect of vagal stimulation versus sham stimulation on insulin sensitivity, on insulin secretion, glucose tolerance, resting energy expenditure, and on parasympathetic tone (analysis of heart rate variability).
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
- Single (Participant)
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
- •HbA1c <6.5%
- •Must be able to understand the explanations of the study and the instructions
排除标准
- •Any relevant (according to investigator's judgment) cardiovascular disease
- •Neurological and psychiatric disorders
- •Diabetes mellitus
- •Active implants (e.g. pacemaker, cochlear implant, cerebral shunt)
- •skin diseases on the ear
研究组 & 干预措施
Transauricular vagus nerve stimulation
Non invasive vagus nerve stimulation will be conducted with Cerbomed NEMOS via the left ear.
干预措施: Transauricular vagus nerve stimulation (Device)
Transauricular sham stimulation
Non invasive sham stimulation will be conducted with Cerbomed NEMOS via the left ear lobe.
干预措施: Transauricular sham stimulation (Device)
结局指标
主要结局
Whole body insulin sensitivity
时间窗: 0-120 min
Insulin sensitivity will be assessed by a 75g OGTT.
次要结局
- Insulin secretion(0-120 min)
- Glucose tolerance(0-120 min)
- Heart rate variability(-30 - 120 min)
- Resting energy expenditure(140-160 min. after start of stimulation)