Importance of Liver Innervation for the Osmopressor Response in Humans

NCT01237431 | Completed

• 1 other identifier: D-MHH-Hep_Reflex-EK5413
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PHYSIOLOGICAL PHENOMENA

Keywords

Water drinking; osmoreceptors; autonomic failure; syncope; blood pressure; liver transplant

Outcome Measures

Primary Outcomes (1)

• norepinephrine plasma level

  30-40 minutes after water drinking

Secondary Outcomes (1)

• pressure response

  blood pressure 30-40 minutes after water drinking

Study Arms (2)

liver transplanted patients

EXPERIMENTAL

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

Dietary Supplement: 500ml water intake

kidney transplanted patients

ACTIVE COMPARATOR

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

Dietary Supplement: 500ml water intake

Interventions

500ml water intake DIETARY_SUPPLEMENT

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

kidney transplanted patients; liver transplanted patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Hannover Medical School

Hanover, NDS, 30625, Germany

Location

Related Publications (1)

• 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.

  PMID: 22016786 DERIVED

MeSH Terms

Conditions

Pure Autonomic Failure; Syncope

Interventions

Drinking

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Eating; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 9, 2010
• Study Start: November 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: February 23, 2011

Record last verified: 2009-08

Locations

DE (1)