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Transport of Satiety Factors Into the CSF

U

University Hospital Tuebingen

Status

Unknown

Conditions

Obesity

Treatments

Diagnostic Test: oral glucose tolerance test
Drug: effect of insulin on peptide transport
Other: circadian rhythm

Study type

Interventional

Funder types

Other

Identifiers

NCT04038086
397/2019BO1

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 3 patient groups

oral glucose tolerance test
Experimental group
Treatment:
Diagnostic Test: oral glucose tolerance test
circadian rhythm
Other group
Treatment:
Other: circadian rhythm
effect of insulin on peptide transport
Experimental group
Treatment:
Drug: effect of insulin on peptide transport

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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