Influence of Osmotic Stimulation of Vasopressin on Autonomic Function

Sponsor

University of North Carolina, Greensboro (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04233606

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The regulation of total body water that defines human hydration status is a complex and dynamic process. Current methods of assessing hydration status (e.g. hematologic and urinary analyses) lack the ability to track changes in hydration status in real-time due to whole-body homeostatic physiologic processes required to maintain central pressure and cardiovascular function. This project will address this problem by assessing the relationship between autonomic function (measured using heart rate variability), a brain-derived process that regulates cardiovascular function, and changes in the hydration-mediated hormone vasopressin.

Condition or Disease	Intervention/Treatment	Phase
Water Stress Body Water Dehydration	Other: Hypertonic Saline Other: Normal Saline	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Participants will complete two trials under two different hydration states: isovolemic increase in plasma osmolality and isovolemic control (maintain normal plasma osmolality)Participants will complete two trials under two different hydration states: isovolemic increase in plasma osmolality and isovolemic control (maintain normal plasma osmolality)

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Influence of Osmotic Stimulation of Vasopressin on Autonomic Function

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Participants will be infused with normal (0.9% NaCL) saline for a 120 minute period.	Other: Normal Saline Infusion of normal saline to inhibit the secretion of the hormone vasopressin
Experimental: Hypertonic Saline Participants will be infused with hypertonic (3% NaCL) saline for a 120 minute period.	Other: Hypertonic Saline Infusion of hypertonic saline to induce an osmotic secretion of the hormone vasopressin

Arm

Intervention/Treatment

Placebo Comparator: Control

Participants will be infused with normal (0.9% NaCL) saline for a 120 minute period.

Other: Normal Saline

Infusion of normal saline to inhibit the secretion of the hormone vasopressin

Experimental: Hypertonic Saline

Participants will be infused with hypertonic (3% NaCL) saline for a 120 minute period.

Other: Hypertonic Saline

Infusion of hypertonic saline to induce an osmotic secretion of the hormone vasopressin

Outcome Measures

Primary Outcome Measures

Change in autonomic function [0, 15, 30, 45, 60, 75, 90, 105, 120 minutes of saline infusion period]
Changes in parasympathetic and sympathetic tone as measured by heart rate variability

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Males and Females between the ages of 18 - 35

Exclusion Criteria:

1. evidence of clinically relevant diseases that may alter body water regulation (e.g., diabetes, kidney disease, metabolic disorders, cardiovascular disease, and other potential fluid balance covariates such as habitual use of non-steroidal anti-inflammatory drugs or serotonin reuptake inhibitors,

previous surgery on the digestive tract that may impair the body's ability to normally regulate body water,
regular drug treatment within the previous 15 days,
actively attempting to gain or lose body weight,
For female participants, testing will take place during the early follicular phase of their menstrual cycle (days 1-8) to maintain consistency in the hydration status measures as total body water fluctuates over the course of the menstrual cycle. Females who are currently using contraceptives (e.g., IUD) that limit the number of menstrual cycles occurring in a given year will be excluded from this study to ensure accuracy in the testing periods for this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina at Greensboro	Greensboro	North Carolina	United States	27412

Sponsors and Collaborators

University of North Carolina, Greensboro

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

William Adams, Assistant Professor, University of North Carolina, Greensboro

ClinicalTrials.gov Identifier:

NCT04233606

Other Study ID Numbers:

20-0206

First Posted:

Jan 18, 2020

Last Update Posted:

Feb 11, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by William Adams, Assistant Professor, University of North Carolina, Greensboro

Vasopressin

Heart Rate Variability

Cardiovascular Function

Autonomic Function

Additional relevant MeSH terms:

Dehydration

Study Results

No Results Posted as of Feb 11, 2022