Clinical Utility of SUDOSCAN in the Pediatric Population

Diabetes Clinical Trial

Official title:

Clinical Utility of SUDOSCAN in the Pediatric Population

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02216201
• Other study ID #: Impeto-015
• Status: Withdrawn
• Phase: N/A
• First received: August 7, 2014
• Last updated: November 7, 2014
• Start date: December 2014

Study information

• Verified date: November 2014
• Source: Impeto Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 17 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Childhood Obesity
• Diabetes
• Pediatric Obesity
• Prediabetes

Locations

Country	Name	City	State
United States	University of Southern California's Childhood Obesity Research Center (CORC)	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Impeto Medical

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Müller 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. — View Citation

Müller 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline	No