Importance of Liver Innervation for the Osmopressor Response in Humans

NCT ID: NCT01237431

Last Updated: 2011-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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PHYSIOLOGICAL PHENOMENA

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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liver transplanted patients

Target group to confirm the hypothesis. Transplantation has to be between 6 an 24 Month before participation.

Group Type EXPERIMENTAL

500ml water intake

Intervention Type DIETARY_SUPPLEMENT

subjects have to ingest 500ml water within 5 minutes after resting 30 minutes in supine position

kidney transplanted patients

Control group, age, gender and medication matched. Transplantation has to be between 6 an 24 Month before participation.

Group Type ACTIVE_COMPARATOR

500ml water intake

Intervention Type DIETARY_SUPPLEMENT

subjects have to ingest 500ml water within 5 minutes after resting 30 minutes in supine position

Interventions

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500ml water intake

subjects have to ingest 500ml water within 5 minutes after resting 30 minutes in supine position

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Medical School Hannover

Locations

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Hannover Medical School

Hanover, NDS, Germany

Site Status

Countries

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Germany

References

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May M, Gueler F, Barg-Hock H, Heiringhoff KH, Engeli S, Heusser K, Diedrich A, Brandt A, Strassburg CP, Tank J, Sweep FC, Jordan J. Liver afferents contribute to water drinking-induced sympathetic activation in human subjects: a clinical trial. PLoS One. 2011;6(10):e25898. doi: 10.1371/journal.pone.0025898. Epub 2011 Oct 7.

Reference Type DERIVED
PMID: 22016786 (View on PubMed)

Other Identifiers

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D-MHH-Hep_Reflex-EK5413

Identifier Type: -

Identifier Source: org_study_id

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