Influence of Osmotic Stimulation of Vasopressin on Autonomic Function

Body Water Dehydration Clinical Trial

Official title:

Influence of Osmotic Stimulation of Vasopressin on Autonomic Function

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04233606
• Other study ID #: 20-0206
• Status: Withdrawn
• Phase: N/A
• Start date: November 2023
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: University of North Carolina, Greensboro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Water Dehydration
• Dehydration
• Water Stress

Intervention

Other:
• Hypertonic Saline
Infusion of hypertonic saline to induce an osmotic secretion of the hormone vasopressin
• Normal Saline
Infusion of normal saline to inhibit the secretion of the hormone vasopressin

Locations

Country	Name	City	State
United States	University of North Carolina at Greensboro	Greensboro	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Greensboro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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