Ignite Creation Date:
2024-05-06 @ 2:36 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02084797
Status:
COMPLETED
Last Update Posted:
2016-05-12
First Post:
2014-03-10
Brief Title:
V2 Receptor Effects on Fluid Regulation and Performance
Sponsor:
Oakland University
Organization:
Oakland University
Study Overview
Official Title:
Revisiting the Human Sweat Gland - Does Arginine Vasopressin Modulate Sweat Sodium Concentration Via the V2 Receptor
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 subjects 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 02mg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None