Trial Outcomes & Findings for V2 Receptor Effects on Fluid Regulation and Performance (NCT NCT02084797)
NCT ID: NCT02084797
Last Updated: 2016-05-12
Results Overview
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)
COMPLETED
NA
10 participants
4 study trials (4 weeks)
2016-05-12
Participant Flow
Participants received all three interventions in randomized fashion.
Participant milestones
| Measure |
1/Placebo, V2R Agonist, V2R Antagonist
This 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).
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
V2 Receptor Effects on Fluid Regulation and Performance
Baseline characteristics by cohort
| Measure |
1/Placebo, V2R Agonist, V2R Antagonist
n=10 Participants
This 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).
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Age, Continuous
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35.5 years
STANDARD_DEVIATION 13.1 • n=5 Participants
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Sex: Female, Male
Female
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2 Participants
n=5 Participants
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Sex: Female, Male
Male
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8 Participants
n=5 Participants
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Region of Enrollment
United States
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10 participants
n=5 Participants
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years of running experience
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8.8 years
STANDARD_DEVIATION 8.7 • n=5 Participants
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BMI
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22.5 kg/m2
STANDARD_DEVIATION 3.3 • n=5 Participants
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VO2 Peak
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58.7 ml/kg/minute
STANDARD_DEVIATION 6.2 • n=5 Participants
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Peak treadmill running speed
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11.0 mph
STANDARD_DEVIATION 1.4 • n=5 Participants
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PRIMARY outcome
Timeframe: 4 study trials (4 weeks)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)
Outcome measures
| Measure |
1/Placebo, V2R Agonist, V2R Antagonist
n=10 Participants
This 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).
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Sweat Sodium Concentration Obtained After the Steady-state Portion of the Trial
V2R Agonist
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76.8 mEq/L
Standard Deviation 24.5
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Sweat Sodium Concentration Obtained After the Steady-state Portion of the Trial
Placebo
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80.1 mEq/L
Standard Deviation 21.6
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Sweat Sodium Concentration Obtained After the Steady-state Portion of the Trial
V2R Antagonist
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84.7 mEq/L
Standard Deviation 25.7
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SECONDARY outcome
Timeframe: 4 study trials (4 weeks)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.
Outcome measures
| Measure |
1/Placebo, V2R Agonist, V2R Antagonist
n=10 Participants
This 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).
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Urine Sodium Concentration After the Steady-state Portion of the Trial
Placebo
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82.0 mEq/L
Standard Deviation 48.5
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Urine Sodium Concentration After the Steady-state Portion of the Trial
V2R Agonist
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89.3 mEq/L
Standard Deviation 21.5
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Urine Sodium Concentration After the Steady-state Portion of the Trial
V2R Antagonist
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16.4 mEq/L
Standard Deviation 5.0
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SECONDARY outcome
Timeframe: 4 study trials (4 weeks)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.
Outcome measures
| Measure |
1/Placebo, V2R Agonist, V2R Antagonist
n=10 Participants
This 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).
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Blood Sodium Concentration
Placebo
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143.6 mEq/L
Standard Deviation 1.5
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Blood Sodium Concentration
V2R Agonist
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144.3 mEq/L
Standard Deviation 2.3
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Blood Sodium Concentration
V2R Antagonist
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145.9 mEq/L
Standard Deviation 2.0
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SECONDARY outcome
Timeframe: 4 trials (4 weeks)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.
Outcome measures
| Measure |
1/Placebo, V2R Agonist, V2R Antagonist
n=10 Participants
This 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).
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Saliva Sodium Concentration
Placebo
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20.5 mEq/L
Standard Deviation 11.0
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Saliva Sodium Concentration
V2R Agonist
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28.1 mEq/L
Standard Deviation 9.5
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Saliva Sodium Concentration
V2R Antagonist
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31.0 mEq/L
Standard Deviation 13.3
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OTHER_PRE_SPECIFIED outcome
Timeframe: 4 trials (4 weeks)Changes in body weight during the V2R antagonist, agonist and placebo conditions will provide researchers with an additional measure of overall fluid balance (fluid in versus fluid out) as well as an estimate of overall sweat water losses.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 trials (4 weeks)Measurement of core temperature using an ingestible CorTemp sensor during the V2R antagonist, agonist and placebo trials will allow researchers to assess if fluid homeostasis and thermoregulation were intertwined in response to each pharmacological intervention.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 trials (4 weeks)To determine if fluid intake behaviors were appropriately regulated in response to the V2R antagonist, agonist and placebo conditions during exercise.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeks (4 trials)To determine if sodium preference ratings were appropriately regulated in response to the V2R antagonist, agonist and placebo conditions during exercise.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 trials (4 weeks)To determine if exercise performance, as determined by overall exercise time, was affected in response to the V2R antagonist, agonist and placebo conditions.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeks (4 trials)To determine if fluid intake behaviors were appropriately regulated in response to the V2R antagonist, agonist and placebo conditions during exercise.
Outcome measures
Outcome data not reported
Adverse Events
1/Placebo, V2R Agonist, V2R Antagonist
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place