Clinical Utility of SUDOSCAN in the Pediatric Population

Impeto Medical

Overview

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

Study Type

OBSERVATIONAL

Conditions

Childhood Obesity Prediabetes Diabetes

Eligibility

Sex: ALLMin age: 8 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Southern California's Childhood Obesity Research Center (CORC)

Los Angeles, California, United States

Outcomes

Primary Outcomes

Identification of participants with abnormal SUDOSCAN electrochemical skin conductance scores

* Sweat gland function will be assessed within each age group * Correlation with parameters associated with pre-diabetes and diabetes

Time frame: Baseline

Data from ClinicalTrials.gov

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