Clinical Utility of SUDOSCAN in the Pediatric Population
NCT ID: NCT02216201
Last Updated: 2014-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2014-12-31
Brief Summary
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Primary Objective: To measure sweat gland function in a pediatric population
Secondary Objective: To determine thresholds on the SUDOSCAN scale for abnormal sweat gland function in the pediatric population
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Able to give assent as well as parental consent
Exclusion Criteria
* Chronic autoimmune condition
* Taking chronic immunosuppressive or anti-inflammatory medications
* Unable to apply palms of the hands and soles of the feet on the sensor plates during a 3 minute Sudoscan test
* Presence of hepatitis B or C
* Presence of HIV
* Presence of known neurological disorder
* Pregnancy and/or breastfeeding
* Any open wound on the soles of the feet or palms of the hands
* Participation in an ongoing clinical investigational drug trial
* Other serious medical conditions that in the opinion of the investigator, would compromise the subject's participation in the study
8 Years
17 Years
ALL
Yes
Sponsors
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Impeto Medical
INDUSTRY
Responsible Party
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Locations
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University of Southern California's Childhood Obesity Research Center (CORC)
Los Angeles, California, United States
Countries
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References
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Muller G, Olschewski J, Stange T, Hjellset VT, Bornstein S, Schwarz PE. Non-invasive screening of diabetes risk by assessing abnormalities of sudomotor function. Exp Clin Endocrinol Diabetes. 2015 Jan;123(1):34-8. doi: 10.1055/s-0033-1357128. Epub 2014 May 5.
Muller G, Parfentyeva E, Olschewsky J, Bornstein SR, Schwarz PE. Assessment of small fiber neuropathy to predict future risk of type 2 diabetes. Prim Care Diabetes. 2013 Dec;7(4):269-73. doi: 10.1016/j.pcd.2013.08.001. Epub 2013 Sep 27.
Chen L, Chen X, Ding R, Shi Q Jr, Hu D. Evaluation of EZSCAN as a screening tool for impaired glucose metabolism. Diabetes Res Clin Pract. 2013 May;100(2):210-4. doi: 10.1016/j.diabres.2013.03.001. Epub 2013 Mar 22.
Other Identifiers
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Impeto-015
Identifier Type: -
Identifier Source: org_study_id