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Completed

NCT Number: NCT00589134

The Effects of Estradiol and Progesterone on Arginine Vasopressin Regulation and Serum Sodium Concentration

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 and/or 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 (i.e. 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 antagonist+estradiol; and 3) during GnRH antagonist+estradiol+ progesterone. During exercise, fluid will be replaced with either water or a carbohydrate-electrolyte beverage (random assignment).

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

John B. Pierce Laboratory

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy volunteers (18-35 yrs) with and without previous exercise induced hyponatremia

Exclusion criteria

  • conditions that would preclude safe exercise or safe use of hormones

Treatment and study plan

Gatorade Endurance Formula

Dietary Supplement

carbohydrate electrolyte beverage

ganirelix acetate

Other

GnRH antagonist, subcutaneous injection, 0.25 mg/day for 21 days.

Other names: Antagon

Primary outcomes

  1. osmotic regulation of AVP

    Time frame: 3 years

Secondary outcomes

  1. temperature responses

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 9, 2008
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.