V2 Receptor Effects on Fluid Regulation and Performance

NCT ID: NCT02084797

Last Updated: 2016-05-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Ten healthy habitual runners (\> 50km running per week) between 18-60 years of age participated in this double blind randomized control trial. Each subject presented to the exercise lab on four separate occasions. Trial 1 was a familiarization trial to determine each subject's maximal aerobic capacity and peak treadmill running speak (VO2 Peak test). Trials 2, 3 and 4 utilized the same exact protocol, differing only in pharmacological intervention. In a randomized, double-blind order (both participant and investigator blinded to the intervention), either a placebo pill, the V2 receptor antagonist tolvaptan (Samsca™, 30mg tablet), or the V2 receptor agonist desmopressin (DDAVP™, 0.2mg tablet) was ingested along with the CorTemp™ Core Temperature Sensor two hours before commencement of the Exercise Trial with 240mL of bottled water. The exercise protocol consisted of 60 minutes of treadmill running at 60% of peak speed (steady-state) followed by a performance test (the VO2 Peak test). Blood, saliva and urine, were collected before the exercise trial (baseline) and again after both the steady-state run and performance runs. Sweat was obtained from sweat patches after both the steady-state and performance runs. Core temperature, fluid intake, performance time, body weight, thirst and sodium palatability ratings were also assessed. Free access to water was allowed during the trial and all urine produced during the trial was measured and collected. The main outcome measure was sweat sodium concentration.

Conditions

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Electrolyte Imbalance Hyponatremia Hypernatremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

V2R (Vasopressin 2 receptor)

Intervention Type 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).

Interventions

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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).

Intervention Type DRUG

Other Intervention Names

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V2R antagonist: tolvaptan (30mg tablet) V2R agonist: desmopressin (0.2mg tablet)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Georgetown University

OTHER

Sponsor Role collaborator

Oakland University

OTHER

Sponsor Role lead

Responsible Party

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Tamara Hew-Butler

Assoc Prof Exercise Science, Exercise Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tamara D Hew-Butler, PhD

Role: PRINCIPAL_INVESTIGATOR

Oakland University

Joseph G Verbalis, MD

Role: STUDY_DIRECTOR

Georgetown University

Locations

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Oakland University

Rochester, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 24944242 (View on PubMed)

Other Identifiers

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RAM#4713

Identifier Type: -

Identifier Source: org_study_id

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