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Influence of Osmotic Stimulation of Vasopressin on Autonomic Function

Influence of Osmotic Stimulation of Vasopressin on Autonomic Function

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04233606
Enrollment
0
Registered
2020-01-18
Start date
2023-11-30
Completion date
2024-07-31
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Water Dehydration, Water Stress

Keywords

Vasopressin, Heart Rate Variability, Cardiovascular Function, Autonomic Function

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.

Interventions

OTHERHypertonic Saline

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

OTHERNormal Saline

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

Sponsors

University of North Carolina, Greensboro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

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)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
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, 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in autonomic function0, 15, 30, 45, 60, 75, 90, 105, 120 minutes of saline infusion periodChanges in parasympathetic and sympathetic tone as measured by heart rate variability

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026