Ignite Creation Date:
2024-05-05 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 9:40 AM
Study NCT ID:
NCT00589134
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2008-01-02
Brief Title:
The Effects of Estradiol and Progesterone on Arginine Vasopressin Regulation and Serum Sodium Concentration
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
The Effects of Estradiol and Progesterone on Arginine Vasopressin Regulation and Serum Sodium Concentration
Status:
COMPLETED
Status Verified Date:
2010-07
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:
Women are at greater risk for exercise-induced hyponatremia low blood sodium concentration and this risk has been attributed to their lower body weight and size excess water ingestion and longer racing times relative to men While these factors contribute to the greater incidence of hyponatremia in women it is likely that their greater levels of estradiol in plasma andor tissue also play a role in increasing the risk of hyponatremia in women More importantly estradiol may also leave women more susceptible to the extreme consequences of hyponatremia ie brain damage death Hyponatremia is generally attributed to inappropriately elevated levels of the hormone arginine vasopressin AVP AVP is the most important hormone controlling water retention in the kidney Earlier studies in our laboratory have demonstrated that estradiol lowers the threshold for thirst sensation and AVP release during exercise The purpose of these studies is to test the hypotheses that in women with a history of hyponatremia estradiol lowers the thresholds for thirst and AVP release leading to greater fluid retention lower blood sodium concentration during endurance exercise in the heat However we further hypothesize that progesterone administration along with estradiol administration will attenuate the effect of estradiol on the regulation of thirst and AVP normalize fluid retention and serum sodium concentration during endurance exercise in the heat In women without a history of hyponatremia we expect that estradiol administration will lower the thresholds for thirst and AVP release but will not increase fluid retention or reduce blood sodium concentration during endurance exercise in the heat We hypothesize that progesterone administration along with estradiol administration will attenuate the effect of estradiol on thirst and AVP but have no effect on fluid retention or serum sodium concentration during endurance exercise in the heat To test these hypotheses women will perform endurance exercise in the heat under three hormonal conditions 1 during Gonadotropin-releasing hormone GnRH antagonist alone--which will suppress estradiol and progesterone 2 during GnRH antagonistestradiol and 3 during GnRH antagonistestradiol progesterone During exercise fluid will be replaced with either water or a carbohydrate-electrolyte beverage random assignment
Detailed Description:
None
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