Childhood ObesityNCT02216201
Clinical Utility of SUDOSCAN in the Pediatric Population
An observational study of Childhood Obesity and Prediabetes, run by Impeto Medical at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Prediabetes, Diabetes
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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).
Who may be able to join
- Males and females ages 8 to 17 years
- Able to give assent as well as parental consent
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California's Childhood Obesity Research Center (CORC)
Los Angeles, California, 90033
About this study
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
- Conditions
- Childhood Obesity, Prediabetes, Diabetes
- Medical subject headings
- Pediatric Obesity, Prediabetic State, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
Why it stopped: Sponsor terminated study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Impeto Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216201
- Sponsor's protocol ID
- Impeto-015
- Status last verified
- Nov 2014
- First submitted
- 7 Aug 2014
- Last updated
- 11 Nov 2014
- Results posted
- No
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 24798863Muller 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 24076379Chen 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of SUDOSCAN in the Pediatric Population
- ClinicalTrials.gov ID
- NCT02216201
- Acronym / sponsor ID
- Impeto-015
- Conditions
- Childhood Obesity, Prediabetes, Diabetes
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor terminated study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Impeto MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 13 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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).
Key inclusion criteria (2 listed)
- Males and females ages 8 to 17 years
- Able to give assent as well as parental consent
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of participants with abnormal SUDOSCAN electrochemical skin conductance scores
Time frame: Baseline
* Sweat gland function will be assessed within each age group * Correlation with parameters associated with pre-diabetes and diabetes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2014.
- Background: PubMed 24798863Muller 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.
- Background: PubMed 24076379Muller 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.
- Background: PubMed 23529065Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity and Prediabetes, run by Impeto Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of participants with abnormal SUDOSCAN electrochemical skin conductance scores (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02216201, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2014.