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Trial · Interventional

CompletedNot applicableResults postedRegistry data

V2 Receptor Effects on Fluid Regulation and Performance

NCTNCT02084797 (opens ClinicalTrials.gov in a new tab)Other idRAM#4713
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
10 participants (actual)
Sponsor
Oakland University · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
Jun 2011
Primary completion
Oct 2011
Completion
Oct 2012
First posted
12 Mar 2014 (estimated)
Last update posted
12 May 2016 (estimated)
Conditions
Electrolyte Imbalance · Hyponatremia · Hypernatremia

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201120122013
  1. N/A

    V2 Receptor Effects on Fluid Regulation and Performance

    NCT02084797

    Jun 2011 to Oct 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • V2R (Vasopressin 2 receptor)Drug

Arms1

  • Experimental

    all study participants

    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

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 4 study trials (4 weeks)

    Registry description

    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)

Secondary outcomes(3)

  1. Urine Sodium Concentration After the Steady-state Portion of the Trial

    Time frame · 4 study trials (4 weeks)

    Registry description

    Changes in urine sodium concentration after use of the V2R antagonist, agonist and placebo interventions will verify whether or not pharmacologic activation or inhibition was successfully induced.

  2. Blood Sodium Concentration

    Time frame · 4 study trials (4 weeks)

    Registry description

    Measurement of blood sodium concentration will determine if normonatremia (blood sodium concentrations within the normal physiological range of 135-145mmol/L) were maintained throughout the trial with appropriate fluid intake during the V2R antagonist, agonist and placebo intervention trials.

  3. Saliva Sodium Concentration

    Time frame · 4 trials (4 weeks)

    Registry description

    Measurement of salivary sodium concentration will allow us to determine if the V2R antagonist, agonist and placebo interventions activate aquaporin-5 (AQP5) water channels that are also located in sweat glands. If the V2R acts on the sweat glands through AQP5, there should be parallel changes in sweat, urine and saliva sodium concentrations with each pharmaceutical intervention.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 4 study trials (4 weeks)

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

GroupValue (mEq/L)Spread
1/Placebo, V2R Agonist, V2R Antagonist80.121.6
Secondary and other outcome results(7)
Secondary outcomeMean· 4 study trials (4 weeks)

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

GroupValue (mEq/L)Spread
1/Placebo, V2R Agonist, V2R Antagonist82.048.5
Secondary outcomeMean· 4 study trials (4 weeks)

Blood Sodium Concentration

GroupValue (mEq/L)Spread
1/Placebo, V2R Agonist, V2R Antagonist143.61.5
Secondary outcomeMean· 4 trials (4 weeks)

Saliva Sodium Concentration

GroupValue (mEq/L)Spread
1/Placebo, V2R Agonist, V2R Antagonist20.511.0
Other pre specified outcome· 4 trials (4 weeks)

Body Weight

GroupValue
Other pre specified outcome· 4 trials (4 weeks)

Core Temperature

GroupValue
Other pre specified outcome· 4 trials (4 weeks)

Thirst Rating

GroupValue
Other pre specified outcome· 4 weeks (4 trials)

Sodium Palatability Ratings

GroupValue

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
1/Placebo, V2R Agonist, V2R AntagonistThis study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed. V2R (Vasopressin 2 receptor): 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).–0 / 100 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedHew-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

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 60 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Healthy (no acute or chronic medical conditions or regular prescription medication use), habitual (\>50km/week) * Distance runners between the ages of 18-60 years. Exclusion Criteria: * 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.

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