Transport of Satiety Factors Into the CSF

Not Applicable

• Conditions: Obesity
• Interventions: Diagnostic Test: oral glucose tolerance test; Other: circadian rhythm; Drug: effect of insulin on peptide transport

• Registration Number: NCT04038086
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-15
• Study First Submitted: 2019-07-15
• Study First Submitted QC: 2019-07-26
• Study First Posted: 2019-07-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-25
• Last Update Posted: 2022-03-28
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral glucose tolerance test	oral glucose tolerance test	-
circadian rhythm	circadian rhythm	-
effect of insulin on peptide transport	effect of insulin on peptide transport	-

Primary Outcome Measures

Name	Time	Method
Insulin 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	Insulin will be measured in serum and CSF and the ratio will be calculated.

Secondary Outcome Measures

Name	Time	Method
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	Ghrelin will be measured in serum and CSF and the ratio will be calculated.
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	Leptin will be measured in serum and CSF and the ratio will be calculated.
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	FGF21 and FGF23 will be measured in serum and CSF and the ratio will be calculated.
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	Proglucagon cleavage products will be measured in serum and CSF and the ratio will be calculated.
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	PYY will be measured in serum and CSF and the ratio will be calculated.

Trial Locations

Locations (1)

University of Tuebingen, Department of Internal Medicine IV; 🇩🇪 Tübingen, Germany