V2 Receptor Effects on Fluid Regulation and Performance

NCT02084797 | Completed Results

• 1 other identifier: RAM#4713
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This primary aim of this study was to critically assess whether or not sweat water content and sodium concentration were acutely regulated by dynamic changes in antidiuretic hormone (arginine vasopressin or AVP) acting on the Vasopressin 2 receptor (V2R) during exercise. Secondary aims were to evaluate running performance and core temperature to further characterize the role of AVP in the coordinated balance of fluid and temperature homeostasis during exercise. The primary hypothesis was that activation of the V2R in sweat glands would result in water reabsorption and fluid conservation during endurance exercise.

Conditions

Electrolyte Imbalance; Hyponatremia; Hypernatremia

Keywords

arginine vasopressin; sweat sodium; V2 antagonist; running

Outcome Measures

Primary Outcomes (1)

• Sweat Sodium Concentration Obtained After the Steady-state Portion of the Trial

  Changes in sweat sodium concentration will parallel changes in urine sodium concentration with use of the V2R antagonist, agonist and placebo if the primary hypothesis is true (sweat sodium is regulated by the V2R, similar to how urine sodium is regulated by principle cells located within in the kidney collecting duct)

  4 study trials (4 weeks)

Secondary Outcomes (3)

• Urine Sodium Concentration After the Steady-state Portion of the Trial

  4 study trials (4 weeks)

• Blood Sodium Concentration

  4 study trials (4 weeks)

• Saliva Sodium Concentration

  4 trials (4 weeks)

Other Outcomes (6)

• Body Weight

  4 trials (4 weeks)

• Core Temperature

  4 trials (4 weeks)

• Thirst Rating

  4 trials (4 weeks)

Study Arms (1)

all study participants

EXPERIMENTAL

All study participants received all interventions. V2R Antagonist: 30mg Tolvaptan tablet ingested 2 hours before exercise. V2R agonist: 0.2mg DDAVP tablet ingested 2 hours before exercise Placebo

Drug: V2R (Vasopressin 2 receptor)

Interventions

V2R (Vasopressin 2 receptor) DRUG

All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state).

Also known as: V2R antagonist: tolvaptan (30mg tablet), V2R agonist: desmopressin (0.2mg tablet)

all study participants

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy (no acute or chronic medical conditions or regular prescription medication use), habitual (\>50km/week)
• Distance runners between the ages of 18-60 years.

You may not qualify if:

• Individuals with chronic medical problems which require regular prescription medication
• Runners with pre-existing kidney problems
• Unable to sense thirst
• Difficulty swallowing
• Gastrointestinal disorders
• History of fainting associated with blood draw.

Sponsors & Collaborators

• Oakland University: lead
• Georgetown University: collaborator

Study Sites (1)

Oakland University

Rochester, Michigan, 48309, United States

Location

Related Publications (1)

• Hew-Butler T, Hummel J, Rider BC, Verbalis JG. Characterization of the effects of the vasopressin V2 receptor on sweating, fluid balance, and performance during exercise. Am J Physiol Regul Integr Comp Physiol. 2014 Aug 15;307(4):R366-75. doi: 10.1152/ajpregu.00120.2014. Epub 2014 Jun 18.

  PMID: 24944242 DERIVED

MeSH Terms

Conditions

Hyponatremia; Hypernatremia; Diabetes Insipidus

Interventions

Tablets

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; 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)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Tamara Hew-Butler
• Organization: Oakland University

hew@oakland.edu

248-364-8686

Study Officials

• Tamara D Hew-Butler, PhD

  Oakland University

  PRINCIPAL INVESTIGATOR

• Joseph G Verbalis, MD

  Georgetown University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof Exercise Science, Exercise Science

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: March 12, 2014
• Study Start: June 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2012
• Last Updated: May 12, 2016
• Results First Posted: May 12, 2016

Record last verified: 2016-04

Locations

US (1)