Pupillographie Als Screeningtest für Cerebrale Insulinresistenz
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Measurements of autonomic nervous system activity by pupillography
研究概览
简要总结
Cerebral insulin action is important in the regulation of whole body glucose metabolism. However, the cerebral insulin action differs between individuals - there is a so called cerebral insulin resistance. The influence of central insulin action on peripheral metabolism seems at least partially mediated via the autonomous nervous system. A noninvasive method to measure autonomic function is the pupillography. The aim of the study is to find out whether pupillography can be used to assess central insulin activity. Thus, pupillography will be performed in 30 normal weight and 30 overweight subjects before and after application insulin intranasally.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •voluntary adults
- •HbA1c <5.8%
- •Age between 18 and 60 years
- •written consent
排除标准
- •There is a pregnancy or pregnancy can not be excluded
- •lactating women
- •Minors or non-consenting subjects are also excluded
- •Acute illness or infection within the last 4 weeks
- •Neurological and psychiatric disorders
- •intake of centrally acting drugs
- •Subjects with hemoglobin levels Hb <12g / dl (in females), Hb <14g / dl (males)
- •Allergic diseases against one of the substances used
研究组 & 干预措施
nasal insulin
160 U of human insulin as nasal spray
干预措施: human insulin (Drug)
nasal insulin
160 U of human insulin as nasal spray
干预措施: Pupillography (Diagnostic Test)
nasal placebo
placebo as nasal spray
干预措施: placebo (Drug)
nasal placebo
placebo as nasal spray
干预措施: Pupillography (Diagnostic Test)
结局指标
主要结局
Measurements of autonomic nervous system activity by pupillography
时间窗: Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application
There will be measurements of autonomic nervous system activity by pupillography in order to identify central insulin action. The primary variable is the pupil width change in pupillography before compared to after intranasal insulin/placebo administration in 30 lean subjects. The investigation takes place in a darkened room with low backlight of about 5-10lx. The pupillographic recording is carried out with a commercially available device, F2D2 (Amtech Germany). In this case, the pupil width is recorded for 6 minutes continuously before and after nasal insulin (also 16 strokes of 10 E) or placebo doses with an infrared camera permanently mounted in a video goggle. Additionally, a possible change of the pupillary light reflection to monochromatic light is measured. Evaluation parameters are latency, amplitude and re-dilatation behavior.
Measurements of latency of pupil response to light stimulation.
时间窗: Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application
There will be measurements of autonomic nervous system activity by pupillography in order to identify central insulin action. The investigation takes place in a darkened room with low backlight of about 5-10lx. The pupillographic recording is carried out with a commercially available device, F2D2 (Amtech Germany). A possible change of the pupillary light reflection to monochromatic light is measured. Evaluation parameter is latency. The responses before and after nasal spray administration will be compared.
Measurements of re-dilation behaviour of pupil response to light stimulation.
时间窗: Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application
There will be measurements of autonomic nervous system activity by pupillography in order to identify central insulin action. The investigation takes place in a darkened room with low backlight of about 5-10lx. The pupillographic recording is carried out with a commercially available device, F2D2 (Amtech Germany). A possible change of the pupillary light reflection to monochromatic light is measured. Evaluation parameter is re-dilatation behavior. The responses before and after nasal spray administration will be compared.
Measurements of amplitude of pupil response to light stimulation.
时间窗: Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application
There will be measurements of autonomic nervous system activity by pupillography in order to identify central insulin action. The investigation takes place in a darkened room with low backlight of about 5-10lx. The pupillographic recording is carried out with a commercially available device, F2D2 (Amtech Germany). A possible change of the pupillary light reflection to monochromatic light is measured. Evaluation parameter is amplitude . The responses before and after nasal spray administration will be compared.
次要结局
- Autonomic nervous system(Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application)