Influence of Osmotic Stimulation of Vasopressin on Autonomic Function

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Water Stress; Body Water Dehydration
• Intervention / Treatment: Other: Normal Saline; Other: Hypertonic Saline

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Greensboro, North Carolina, United States, 27412
      • University of North Carolina at Greensboro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,

  2) previous surgery on the digestive tract that may impair the body's ability to normally regulate body water,

  3) regular drug treatment within the previous 15 days,

  4) actively attempting to gain or lose body weight,

  5) 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of North Carolina, Greensboro

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Heart Rate Variability; Vasopressin; Cardiovascular Function; Autonomic Function
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration
• Other Study ID Numbers: 20-0206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No