Clinical trial NCT04038086: Transport of Satiety Factors Into the CSF
Official title: Transport Von Peripheren Sättigungshormonen in Das Zentrale Nervensystem
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* patients with cerebrospinal fluid drainage

Exclusion Criteria:

* 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

Primary outcomes:
measure: Insulin transport into the CSF
timeFrame: 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
Secondary outcomes:
measure: Transport of proglucagon cleavage products into the CSF
timeFrame: 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
measure: Transport of FGF21 and FGF23 into the CSF
timeFrame: 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
measure: Ghrelin transport into the CSF
timeFrame: 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
measure: PYY transport into the CSF
timeFrame: 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
measure: Leptin transport into the CSF
timeFrame: 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
Other outcomes:
measure: Association with hunger/satiety
timeFrame: fasting state (0 minutes) and last CSF collection (120 minutes in Arm 1, 18 hours in Arm 2, and 240 minutes in Arm 3)
measure: Association with depression-like behaviour
timeFrame: fasting state (0 minutes) and last CSF collection (120 minutes in Arm 1, 18 hours in Arm 2, and 240 minutes in Arm 3)
measure: Association with mood
timeFrame: fasting state (0 minutes) and last CSF collection (120 minutes in Arm 1, 18 hours in Arm 2, and 240 minutes in Arm 3)
Locations:
city: Tübingen
country: Germany
facility: University of Tuebingen, Department of Internal Medicine IV
Study officials:
References: