Biomarkers for Noninvasive Assessment of Human Hydration

Status Completed

Clinical Trial Summary

Low levels of dehydration (the loss of body water corresponding to 2% of the body weight), deteriorate physical and cognitive performance and may also be linked to a number of chronic diseases. The standard test used for the assessment of hydration status is plasma osmolality. This blood test is invasive, requires time and laboratory equipment and is not accurate for isotonic dehydration. The goal of this project is to determine whether a new molecular technology, saliva-based Stress Response Profiling (SRP) biomarkers, could be used for non-invasive diagnostics of dehydration.

Clinical Trial Description

Dehydration, or the loss of body water, is a common health problem during military operations, athletic events and illness, particularly in children and the elderly. Warfighters frequently become dehydrated when training or fighting in hot and mountainous environments because heat and high altitude increase body water losses. The negative consequences of dehydration worsen as body water losses increase. Severe dehydration (>10%) is a life-threatening emergency that may result in heat illness, seizures, permanent brain damage or death. The most common type of dehydration is caused by sweat loss during heavy physical labor or exercise (hypertonic dehydration). A different type of dehydration can be caused by blood loss, burns, diarrhea, vomiting or diuretic drugs used for example by diabetics (isotonic dehydration). Despite the critical importance of proper fluid balance to human performance and health, no field-expedient, non-invasive dehydration test is available for either form of dehydration. The ultimate goal of this project is to develop a field-expedient, non-invasive test for both types of dehydration. The test will be sensitive to 2% dehydration, a critical threshold for performance impairment and a statistically valid decision point for hydration assessment.

Design: Fifteen volunteers will be first euhydrated (well-hydrated) and then moderately dehydrated (2-4%) using two procedures. First, sweat loss during exercise in the heat without fluids (hypertonic dehydration). Second, excessive urination stimulated by a diuretic pill called Lasix (isotonic dehydration). SRP biomarkers in saliva samples will be compared to changes in body weight, and to known hydration indicators in blood and urine. Results will identify the best SRP biomarkers for diagnosing both types of dehydration and compare accuracy of the new saliva test to the existing hydration indicators. ;

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Dehydration

Clinical Trial Details

NCT number	NCT01507129
Study type	Observational
Source	Gaia Medical Institute
Contact
Status	Completed
Phase	N/A
Start date	October 2010
Completion date	August 2012

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.