- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01981902
Non-Invasive Optical Spectroscopic Methods for Dehydration Identification in Marathon Trainees
October 28, 2022 updated by: Beckman Laser Institute and Medical Center, University of California, Irvine
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Irvine, California, United States, 92612
- Beckman Laser Institute University of California Irvine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- male female ages of 18 and 60
- training for a marathon
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Dehydration
Non-Invasive Optical Spectroscopic monitoring method for dehydration
|
Non-Invasive Optical Spectroscopic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hydration
Time Frame: up to 4 weeks
|
Marathon Trainees
|
up to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Matthew Brenner, MD, Beckman Laser Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Anticipated)
August 1, 2018
Study Completion (Anticipated)
August 1, 2018
Study Registration Dates
First Submitted
August 13, 2013
First Submitted That Met QC Criteria
November 5, 2013
First Posted (Estimate)
November 13, 2013
Study Record Updates
Last Update Posted (Actual)
November 1, 2022
Last Update Submitted That Met QC Criteria
October 28, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20129075
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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