Influence of Osmotic Stimulation of Vasopressin on Autonomic Function

NCT04233606 | Withdrawn

• 1 other identifier: 20-0206
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Water Stress; Body Water Dehydration

Keywords

Vasopressin; Heart Rate Variability; Cardiovascular Function; Autonomic Function

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Other: Normal Saline

Hypertonic Saline

EXPERIMENTAL

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

Other: Hypertonic Saline

Interventions

Hypertonic Saline OTHER

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

Hypertonic Saline

Normal Saline OTHER

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

Control

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and Females between the ages of 18 - 35

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• University of North Carolina, Greensboro: lead

Study Sites (1)

University of North Carolina at Greensboro

Greensboro, North Carolina, 27412, United States

Location

MeSH Terms

Conditions

Dehydration; Diabetes Insipidus

Interventions

Saline Solution, Hypertonic; Saline Solution

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: November 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)