Transport Von Peripheren Sättigungshormonen in Das Zentrale Nervensystem
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Insulin transport into the CSF
研究概览
简要总结
The blood-brain barrier regulates the passage of peripheral built appetite-suppressing hormones from the blood to the brain and informs the brain about the nutritional- and energy status.
The aim of this study is to investigate in which extent the hormones are able to overcome the blood-brain barrier and how long it takes after food intake. Relating thereto indications to the effect of peripheral hormones in the central nervous system and the role of these hormones in the development of overweight are provided.
In this study 30 patients (10 per intervention group) will be recruited. The patients are hospitalized in the local neurosurgery and they have a CSF-drainage due to their neurological primary disease or due to neurosurgical interventions. The patients are examined in each case on the same day.
Simultaneous samplings of blood and CSF are taken from 10 patients after an oral glucose tolerance test. These interventions are carried out to investigate in which extent the appetite-suppressing hormones (e.g. Leptin, Insulin, GLP 1 and Glucagon) reach the liquor and so the central nervous system.
In order to understand the temporal sequence, simultaneous samplings of blood and CSF are taken from 10 other patients at certain points throughout the day.
In a further group of 10 patients will be investigated how the central effective insulin modulates the transport of the other appetite-suppressing hormones. Therefore samplings of blood and CSF are investigated before and after intranasal insulin administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with cerebrospinal fluid drainage
排除标准
- •Women during pregnancy and lactation
- •Participation in other interventional clinical trials
- •severe infection within the last 4 months
- •intake of central effective substances which may interact with the transport processes to be investigated
- •hypersensitivity to any of the substances used
- •diabetes mellitus
- •Patients with CSF results indicative of infectious diseases within the central nervous system
- •subjects with hemoglobin Hb <10 g / dl
- •Patients with a neurosurgical disorder suspected of having a blood-brain barrier disorder
研究组 & 干预措施
oral glucose tolerance test
干预措施: oral glucose tolerance test (Diagnostic Test)
circadian rhythm
干预措施: circadian rhythm (Other)
effect of insulin on peptide transport
干预措施: effect of insulin on peptide transport (Drug)
结局指标
主要结局
Insulin transport into the CSF
时间窗: Sample collection will be from 0 to 120 minutes in Arm 1, 18 hours in Arm 2, and 0 to 240 minutes in Arm 3
Insulin will be measured in serum and CSF and the ratio will be calculated.
次要结局
- Ghrelin transport into the CSF(Sample collection will be from 0 to 120 minutes in Arm 1, 18 hours in Arm 2, and 0 to 240 minutes in Arm 3)
- Leptin transport into the CSF(Sample collection will be from 0 to 120 minutes in Arm 1, 18 hours in Arm 2, and 0 to 240 minutes in Arm 3)
- Transport of FGF21 and FGF23 into the CSF(Sample collection will be from 0 to 120 minutes in Arm 1, 18 hours in Arm 2, and 0 to 240 minutes in Arm 3)
- Transport of proglucagon cleavage products into the CSF(Sample collection will be from 0 to 120 minutes in Arm 1, 18 hours in Arm 2, and 0 to 240 minutes in Arm 3)
- PYY transport into the CSF(Sample collection will be from 0 to 120 minutes in Arm 1, 18 hours in Arm 2, and 0 to 240 minutes in Arm 3)