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Transport of Satiety Factors Into the CSF

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ClinicalTrials.gov Identifier: NCT04038086
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Obesity Diagnostic Test: oral glucose tolerance test Other: circadian rhythm Drug: effect of insulin on peptide transport Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Transport Von Peripheren Sättigungshormonen in Das Zentrale Nervensystem
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : April 1, 2020

Arm Intervention/treatment
Experimental: oral glucose tolerance test 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.

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

Experimental: effect of insulin on peptide transport 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.




Primary Outcome Measures :
  1. Insulin transport into the CSF [ Time Frame: 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 :
  1. Transport of proglucagon cleavage products into the CSF [ Time Frame: 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.

  2. Transport of FGF21 and FGF23 into the CSF [ Time Frame: 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.

  3. Ghrelin transport into the CSF [ Time Frame: 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.

  4. PYY transport into the CSF [ Time Frame: 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.

  5. Leptin transport into the CSF [ Time Frame: 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.


Other Outcome Measures:
  1. Association with hunger/satiety [ Time Frame: fasting state (0 minutes) and last CSF collection (120 minutes in Arm 1, 18 hours in Arm 2, and 240 minutes in Arm 3) ]
    Association of the measured peptides with hunger/satiety ratings (assessed on a visual analog scale) will be tested.

  2. Association with depression-like behaviour [ Time Frame: fasting state (0 minutes) and last CSF collection (120 minutes in Arm 1, 18 hours in Arm 2, and 240 minutes in Arm 3) ]
    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.

  3. Association with mood [ Time Frame: fasting state (0 minutes) and last CSF collection (120 minutes in Arm 1, 18 hours in Arm 2, and 240 minutes in Arm 3) ]
    Association of the measured peptides with mood will be tested. Mood will be assessed by PANAS (Positive and Negative Affect Schedule) questionaire.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038086


Locations
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Germany
University of Tuebingen, Department of Internal Medicine IV Recruiting
Tübingen, Germany, 72076
Contact: Martin Heni, MD    +49 7071 29 82714    martin.heni@med.uni-tuebingen.de   
Contact: Andreas Fritsche, MD    +49 7071 29 82714    andreas.fritsche@med.uni-tuebingen.de   
Principal Investigator: Martin Heni, MD         
Sponsors and Collaborators
University Hospital Tuebingen

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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT04038086     History of Changes
Other Study ID Numbers: 397/2019BO1
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will not be able to share patient level data due to data protection regulations.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs