Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00589134 · ClinicalTrials.gov registry record · NA
The Effects of Estradiol and Progesterone on Arginine Vasopressin Regulation and Serum Sodium Concentration
A NA study of Exercise Induced Hyponatremia, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT00589134 is a NA study of Exercise Induced Hyponatremia that has completed, run by Yale University. The registered enrollment target is 26 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00589134, a NA study of Exercise Induced Hyponatremia, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study 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 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
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Gatorade Endurance Formula
- OTHER ganirelix acetate
Study Locations (1)
Connecticut
- John B. Pierce Laboratory - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2006-01 |
| Est. Completion | 2009-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00589134
The ClinicalTrials.gov registry entry for NCT00589134 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Exercise Induced Hyponatremia appearing as the primary indexed condition, and to 2 interventions - of which Gatorade Endurance Formula is the first listed.
NCT00589134 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT00589134 about?
NCT00589134 is a clinical study titled "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 ...
What is the current status of trial NCT00589134?
This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2006-01. Estimated completion is 2009-12.
What conditions does trial NCT00589134 study?
This clinical trial studies the following conditions: Exercise Induced Hyponatremia.
What interventions are being tested in trial NCT00589134?
The interventions under investigation include: Gatorade Endurance Formula (DIETARY_SUPPLEMENT), ganirelix acetate (OTHER).
Who is sponsoring clinical trial NCT00589134?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00589134 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.