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WithdrawnNCT02216201Updated Nov 11, 2014

Clinical Utility of SUDOSCAN in the Pediatric Population

An observational study in Childhood Obesity, Prediabetes and Diabetes, sponsored by Impeto Medical. Withdrawn at 1 site in United States. Open to participants aged 8 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-11.

Sponsored by Impeto Medical · Observational

Why this study was withdrawn
Sponsor terminated study
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
8 Years to 17 Years
Sex
All
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Study 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

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Conditions studied

  • Childhood Obesity
  • Prediabetes
  • Diabetes

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In context

Pediatric Obesity

1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.

Browse Pediatric Obesity studies →

Lead sponsor

This is the only study on the registry with Impeto Medical as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

100 subjects will be recruited by age group, with approximately 10 subjects representative of each age between 8 and 17. Both lean and obese subjects will be included from University of Southern California's Childhood Obesity Research Center (CORC).

Inclusion criteria

  • Males and females ages 8 to 17 years
  • Able to give assent as well as parental consent

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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

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Study locations

1 site
  • University of Southern California's Childhood Obesity Research Center (CORC)
    Los Angeles, California 90033, United States
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References and documents

Publications

  • 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. PubMed 24798863 ↗
  • 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. PubMed 24076379 ↗
  • 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. PubMed 23529065 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02216201
Lead sponsor
Impeto Medical
Responsible party
Sponsor
First posted
Aug 13, 2014
Start date
Dec 2014
Primary completion
Dec 2015 (estimated)
Last update
Nov 11, 2014
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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