Clinical Utility of SUDOSCAN in the Pediatric Population
Withdrawn
- Conditions
- DiabetesChildhood ObesityPrediabetes
- Registration Number
- NCT02216201
- Lead Sponsor
- Impeto Medical
- Brief Summary
The main purpose of this study is to evaluate whether SUDOSCAN is a valid, accurate clinical device for the the determination of sweat gland function in the pediatric population.
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
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Males and females ages 8 to 17 years
- Able to give assent as well as parental consent
Exclusion Criteria
- History of type 1 or type 2 diabetes
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identification of participants with abnormal SUDOSCAN electrochemical skin conductance scores Baseline * Sweat gland function will be assessed within each age group
* Correlation with parameters associated with pre-diabetes and diabetes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Southern California's Childhood Obesity Research Center (CORC)
🇺🇸Los Angeles, California, United States