Transport of Satiety Factors Into the CSF

Obesity Clinical Trial

Official title:

Transport Von Peripheren Sättigungshormonen in Das Zentrale Nervensystem

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04038086
• Other study ID #: 397/2019BO1
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2022
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Diagnostic 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.

Other:
• circadian rhythm
Blood and CSF will be collected five times throughout the day.

Drug:
• 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.

Locations

Country	Name	City	State
Germany	University of Tuebingen, Department of Internal Medicine IV	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Association with hunger/satiety	Association of the measured peptides with hunger/satiety ratings (assessed on a visual analog scale) will be tested.	fasting state (0 minutes) and last CSF collection (120 minutes in Arm 1, 18 hours in Arm 2, and 240 minutes in Arm 3)
Other	Association with depression-like behaviour	Association of the measured peptides with depression-like behaviour will be tested. Depression-like behaviour will be assessed by the BDI-II (Beck Depression Inventory) questionaire.	fasting state (0 minutes) and last CSF collection (120 minutes in Arm 1, 18 hours in Arm 2, and 240 minutes in Arm 3)
Other	Association with mood	Association of the measured peptides with mood will be tested. Mood will be assessed by PANAS (Positive and Negative Affect Schedule) questionaire.	fasting state (0 minutes) and last CSF collection (120 minutes in Arm 1, 18 hours in Arm 2, and 240 minutes in Arm 3)
Primary	Insulin transport into the CSF	Insulin will be measured in serum and CSF and the ratio will be calculated.	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	Transport of proglucagon cleavage products into the CSF	Proglucagon cleavage products will be measured in serum and CSF and the ratio will be calculated.	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	Transport of FGF21 and FGF23 into the CSF	FGF21 and FGF23 will be measured in serum and CSF and the ratio will be calculated.	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	Ghrelin transport into the CSF	Ghrelin will be measured in serum and CSF and the ratio will be calculated.	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	PYY transport into the CSF	PYY will be measured in serum and CSF and the ratio will be calculated.	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	Leptin transport into the CSF	Leptin will be measured in serum and CSF and the ratio will be calculated.	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