Influence of Osmotic Stimulation of Vasopressin on Autonomic Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Water Stress Body Water Dehydration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type OTHER

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

Hypertonic Saline

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

Group Type EXPERIMENTAL

Hypertonic Saline

Intervention Type OTHER

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

Interventions

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Hypertonic Saline

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

Intervention Type OTHER

Normal Saline

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes