DehydrationNCT01981902
Non-Invasive Optical Spectroscopic Methods for Dehydration Identification in Marathon Trainees
An observational study of Dehydration, run by University of California, Irvine at 1 site in United States.
Trial summary
Dehydration can result from exposure to harsh environments including hot and dry desert climates. Soldiers and non-military workers are frequently required to work in hot, dry conditions, and dehydration can be productivity limiting and life threatening if unrecognized. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- What is being tested?
- Non-Invasive Optical Spectroscopic
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Study population are the volunteers who are training for a marathon individually or under the guidance of the Leukemia Society Team in Training, the American Heart Association, or similar groups. These organizations run programs that include providing group-training situations for individuals interested in preparing for a marathon while participating in fund raising efforts.
Who may be able to join
- male female ages of 18 and 60
- training for a marathon
Who cannot join
- Poorly controlled diabetes mellitus
- Diabetes insipidus (excessive urination of water) as diagnosed by your physician
- disorder of the intestine
- Irritable bowel syndrome with excessive diarrhea, as diagnosed by a physician
- Congestive heart failure and subsequent use of a diuretic "water pill" to remove excess water from the body
- Have poor kidney function
- Have been diagnosed with hyperthyroidism/hypothyroidism by your physician
Trial locations and contacts
1 site in 1 country.
United States1 site
Beckman Laser Institute University of California Irvine
Irvine, California, 92612
About this study
Dehydration can result from exposure to harsh environments including hot and dry desert climates. Soldiers and non-military workers are frequently required to work in hot, dry conditions, and dehydration can be productivity limiting and life threatening if unrecognized.
Read the detailed description
The research can use low power laser technology to take measurements of muscle tissue water content in volunteers before and after marathon training runs to detect dehydration. Two slightly different devices can be used to detect dehydration. 1). diffuse optical spectroscopy and 2). spatial frequency domain imaging-modulated imaging The researchers can determined by use other methods to assess the level of dehydration status in runners. These methods will include taking weight and temperature before and after run, skin-fold measurements pre and post run, and obtaining saliva samples from before and after run. The researchers can determine the study use non-invasive, laser light technology measure tissue water concentrations, as an indicator of dehydration.
- Conditions
- Dehydration
- Being tested
- Non-Invasive Optical Spectroscopic
- Keywords
- Dehydration
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Optical SpectroscopicDevice
Non-Invasive Optical Spectroscopic
| Study group | Role | What they receive |
|---|---|---|
| Dehydration | Non-Invasive Optical Spectroscopic monitoring method for dehydration Receives: Device: Non-Invasive Optical Spectroscopic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydration
Marathon Trainees
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Why it stopped: Not a clinical trial study
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.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Matthew Brenner, MD, Principal investigator, Beckman Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981902
- Sponsor's protocol ID
- 20129075
- Status last verified
- Oct 2022
- First submitted
- 13 Aug 2013
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Optical Spectroscopic Methods for Dehydration Identification in Marathon Trainees
- ClinicalTrials.gov ID
- NCT01981902
- Acronym / sponsor ID
- 20129075
- Conditions
- Dehydration
- Keywords
- Dehydration
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not a clinical trial study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Aug 2013
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 13 Nov 2013 (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.
Dehydration can result from exposure to harsh environments including hot and dry desert climates. Soldiers and non-military workers are frequently required to work in hot, dry conditions, and dehydration can be productivity limiting and life threatening if unrecognized.
Detailed description
The research can use low power laser technology to take measurements of muscle tissue water content in volunteers before and after marathon training runs to detect dehydration. Two slightly different devices can be used to detect dehydration. 1). diffuse optical spectroscopy and 2). spatial frequency domain imaging-modulated imaging The researchers can determined by use other methods to assess the level of dehydration status in runners. These methods will include taking weight and temperature before and after run, skin-fold measurements pre and post run, and obtaining saliva samples from before and after run. The researchers can determine the study use non-invasive, laser light technology measure tissue water concentrations, as an indicator of dehydration.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dehydration | – | Device: Non-Invasive Optical SpectroscopicNon-Invasive Optical Spectroscopic monitoring method for dehydration |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study population are the volunteers who are training for a marathon individually or under the guidance of the Leukemia Society Team in Training, the American Heart Association, or similar groups. These organizations run programs that include providing group-training situations for individuals interested in preparing for a marathon while participating in fund raising efforts.
Key inclusion criteria (2 listed)
- male female ages of 18 and 60
- training for a marathon
Key exclusion criteria (7 listed)
- Poorly controlled diabetes mellitus
- Diabetes insipidus (excessive urination of water) as diagnosed by your physician
- disorder of the intestine
- Irritable bowel syndrome with excessive diarrhea, as diagnosed by a physician
- Congestive heart failure and subsequent use of a diuretic "water pill" to remove excess water from the body
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Invasive Optical SpectroscopicNon-Invasive Optical Spectroscopic | Device | Dehydration |
Primary outcome
Hydration
Time frame: up to 4 weeks
Marathon Trainees
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
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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.
Matthew Brenner, MD principal investigator
Beckman Laser 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 University of California, Irvine 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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 1 Nov 2022. 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 was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
Hydration (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
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 1 Nov 2022.