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Importance of Liver Innervation for the Osmopressor Response in Humans (HEP-Reflex)

H

Hannover Medical School (MHH)

Status

Completed

Conditions

PHYSIOLOGICAL PHENOMENA

Treatments

Dietary Supplement: 500ml water intake

Study type

Interventional

Funder types

Other

Identifiers

NCT01237431
D-MHH-Hep_Reflex-EK5413

Details and patient eligibility

About

In patients with autonomic dysfunction water drinking elicits a pressor response mediated by sympathetic activation. If any, in healthy subjects there is only a slight increase in blood pressure. However, the sympathetic activation is observable by resting energy expenditure increases greater than 20%.

The investigators believe that the response to water may be mediated through sympathetic activation elicited by osmosensitve spinal afferents in the liver. Therefore, the investigators want to test water in liver transplant patients who have a denervated liver. Kidney transplant patients serve as control subjects. The investigators hypothesize that the increase in norepinephrine after water drinking is blunted in liver transplant recipients.

Enrollment

40 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 3 to 24 month past liver or kidney transplantation
  • age 18 to 60
  • written informed consent
  • ability to understand the oral and written information

Exclusion criteria

  • pregnancy or lactation
  • transplantation of another organ
  • chronic heart or vascular disease
  • known alcohol or drug abuse
  • psychiatric diseases (e.g. chronic depression, schizophrenia, drug addiction)

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

liver transplanted patients
Experimental group
Description:
Target group to confirm the hypothesis. Transplantation has to be between 6 an 24 Month before participation.
Treatment:
Dietary Supplement: 500ml water intake
kidney transplanted patients
Active Comparator group
Description:
Control group, age, gender and medication matched. Transplantation has to be between 6 an 24 Month before participation.
Treatment:
Dietary Supplement: 500ml water intake

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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