DehydrationNCT01507129
Biomarkers for Noninvasive Assessment of Human Hydration
An observational study of Dehydration, run by Gaia Medical Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Aerobically fit individuals
Who may be able to join
- Signed Informed Consent Form
- Males and females between 18-40, healthy and aerobically fit determined by VO2max test. Minimum 45 ml/kg/min for males and 40 ml/kg/min for females
- Willing to stop drinking any alcoholic beverages, taking all supplements and limit medications to those approved for the study
- No heart conditions assessed by medical history and passing the PAR-Q
- Complete and pass medical exam
Who cannot join
- Positive response to any PAR-Q questions
- Physical problems/injuries associated with walking or cycling
- VO2Max below 45 ml/kg/min for men and 40 ml/kg/min for women
- Allergy to sulfa drugs
- Existing heart and or lung conditions
- Pregnant or breastfeeding
Show all 14Show fewer
- History of heat illness or heat injury
- History of kidney stones or chronic renal problems
- History of orthostatic hypotension, diabetes or gout
- Taking certain medications: NSAIDS [anti-inflammatory/pain medications], digitalis [a type of heart medication], lithium and anti-depressants [medications used in psychiatry], anti-hypertensives [medications to lower the blood pressure], anti-fungals [medications used to treat infectious type of mold], supplements or anti-cholinergic drugs)
- Taking any supplements, particularly creatine in 24 hours before the start of the study, or during the study
- Alcohol consumption 24 hours before the start of the study, or during the study
- Incapable to give informed consent
- Anemia
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Translational Research Institute
San Diego, California, 92037
About this study
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.
Read the detailed 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.
- Conditions
- Dehydration
- Keywords
- dehydration, plasma, osmolality, saliva, urine, biomarkers, hypertonic, isotonic, hydration
- Medical subject headings
- Dehydration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startOct 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaia Medical Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Peter D Wagner, M.D., Principal investigator, University of California, San DiegoSarka Southern, Ph.D., Principal investigator, Gaia Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507129
- Sponsor's protocol ID
- DM102745
- Status last verified
- Aug 2012
- First submitted
- 6 Jan 2012
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers for Noninvasive Assessment of Human Hydration
- ClinicalTrials.gov ID
- NCT01507129
- Acronym / sponsor ID
- DM102745
- Conditions
- Dehydration
- Keywords
- dehydration, plasma, osmolality, saliva, urine, biomarkers, hypertonic, isotonic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Gaia Medical InstituteIndustry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Oct 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Aerobically fit individuals
Key inclusion criteria (5 listed)
- Signed Informed Consent Form
- Males and females between 18-40, healthy and aerobically fit determined by VO2max test. Minimum 45 ml/kg/min for males and 40 ml/kg/min for females
- Willing to stop drinking any alcoholic beverages, taking all supplements and limit medications to those approved for the study
- No heart conditions assessed by medical history and passing the PAR-Q
- Complete and pass medical exam
Key exclusion criteria (14 listed)
- Positive response to any PAR-Q questions
- Physical problems/injuries associated with walking or cycling
- VO2Max below 45 ml/kg/min for men and 40 ml/kg/min for women
- Allergy to sulfa drugs
- Existing heart and or lung conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
Related trials for Dehydration
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Hypernatremia Fluid Therapy in Childhood Diarrhoea
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Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
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Hydration & Female Life Stages
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter D Wagner, M.D. principal investigator
University of California, San Diego
Sarka Southern, Ph.D. principal investigator
Gaia Medical Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dehydration, run by Gaia Medical Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2012.