Childhood Obesity, Diabetes, Prediabetes
Conditions
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
Interventions
None listed
Sponsors
Impeto Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed