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Influence of Osmotic Stimulation of Vasopressin on Autonomic Function

Primary Purpose

Water Stress, Body Water Dehydration

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypertonic Saline
Normal Saline
Sponsored by
University of North Carolina, Greensboro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Water Stress focused on measuring Vasopressin, Heart Rate Variability, Cardiovascular Function, Autonomic Function

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of North Carolina at Greensboro

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Hypertonic Saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in autonomic function
Changes in parasympathetic and sympathetic tone as measured by heart rate variability

Secondary Outcome Measures

Full Information

First Posted
January 15, 2020
Last Updated
October 31, 2022
Sponsor
University of North Carolina, Greensboro
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1. Study Identification

Unique Protocol Identification Number
NCT04233606
Brief Title
Influence of Osmotic Stimulation of Vasopressin on Autonomic Function
Official Title
Influence of Osmotic Stimulation of Vasopressin on Autonomic Function
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Greensboro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Water Stress, Body Water Dehydration
Keywords
Vasopressin, Heart Rate Variability, Cardiovascular Function, Autonomic Function

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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)
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Participants will be infused with normal (0.9% NaCL) saline for a 120 minute period.
Arm Title
Hypertonic Saline
Arm Type
Experimental
Arm Description
Participants will be infused with hypertonic (3% NaCL) saline for a 120 minute period.
Intervention Type
Other
Intervention Name(s)
Hypertonic Saline
Intervention Description
Infusion of hypertonic saline to induce an osmotic secretion of the hormone vasopressin
Intervention Type
Other
Intervention Name(s)
Normal Saline
Intervention Description
Infusion of normal saline to inhibit the secretion of the hormone vasopressin
Primary Outcome Measure Information:
Title
Change in autonomic function
Description
Changes in parasympathetic and sympathetic tone as measured by heart rate variability
Time Frame
0, 15, 30, 45, 60, 75, 90, 105, 120 minutes of saline infusion period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of North Carolina at Greensboro
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27412
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Influence of Osmotic Stimulation of Vasopressin on Autonomic Function

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