Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2019-07-15
2023-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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oral glucose tolerance test
oral glucose tolerance test
Participants will undergo an 75 gram oral glucose tolerance test. Blood and CSF will be collected in the fasting state before the test and every 30 minutes throughout the test which lasts for 2 hours.
circadian rhythm
circadian rhythm
Blood and CSF will be collected five times throughout the day.
effect of insulin on peptide transport
effect of insulin on peptide transport
Blood and CSF will be collected in the fasting state and 15, 30, 60, 120 und 240 min after administration of 160 U of human insulin as nasal spray.
Interventions
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oral glucose tolerance test
Participants will undergo an 75 gram oral glucose tolerance test. Blood and CSF will be collected in the fasting state before the test and every 30 minutes throughout the test which lasts for 2 hours.
circadian rhythm
Blood and CSF will be collected five times throughout the day.
effect of insulin on peptide transport
Blood and CSF will be collected in the fasting state and 15, 30, 60, 120 und 240 min after administration of 160 U of human insulin as nasal spray.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Locations
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University of Tuebingen, Department of Internal Medicine IV
Tübingen, , Germany
Countries
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Facility Contacts
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Other Identifiers
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397/2019BO1
Identifier Type: -
Identifier Source: org_study_id
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