ClinicalTrials.gg
Sign In
CompletedNCT00466778Updated Sep 21, 2007

Autonomic Nervous System Dysfunction and Peripheral Neuropathy in a Cohort of Asymptomatic Juvenile Diabetic Patients (Type I): A Case-Controlled Study

An observational study in Peripheral Neuropathy and Autonomic Neuropathy, sponsored by Weintraub, Michael I., MD, FACP, FAAN. Completed at 1 site in United States. Open to participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-09-21.

Sponsored by Weintraub, Michael I., MD, FACP, FAAN · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
40
Ages
10 Years to 18 Years
Sex
All
01

Study summary

This is a case-controlled study using an innovative, non-invasive, FDA approved technology to measure the autonomic nervous system. Detection of unsuspected DPN or ANS dysfunction may allow physicians to re-assess current treatment and develop new dietary or pharmacological strategies. This also is an immense public health concern since there are currently 18 million diabetics in the United States and 220 million worldwide.

Read the detailed description

A consecutive cohort of 20 neurologically asymptomatic (absence of numbness, tingling, burning or pain in the feet) patients with Type I from the practice of Dr. Richard Noto (gatekeeper) and associates will be asked with their legal guardians to enroll in this case-controlled study using a battery of safe, neurological tests which are unlikely to be painful. A second group of 20 subjects who are nondiabetic and healthy (age/sex matched) will also be enrolled and undergo the same battery of neurological tests. The battery of tests is highly accurate, objective and safe. Subjects will be referred and enrolled from the private practices of community pediatricians. A BMI derived from the subject's height and weight will be assessed by Dr. Noto. Subjects who are felt to be acceptable by the inclusion criteria will then receive consecutive numbers from 1 to 40 and their initials will follow their specific number for each study.

02

Conditions studied

  • Peripheral Neuropathy
  • Autonomic Neuropathy
03

In context

Peripheral Nervous System Diseases

1,006 studies on the registry are indexed under Peripheral Nervous System Diseases; 179 are open to participants now.

This study's planned enrollment of 40 is below the median of 90 across 191 observational studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

Weintraub, Michael I., MD, FACP, FAAN is the lead sponsor of 6 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Cooperation of the subject and guardian are required for this 60-120 minute evaluation.
  • Capable of understanding and complying with study protocol.
  • Twenty (20) male/females with juvenile diabetes [of at least 3 years duration and no longer than 7] (Type I) who are neurologically asymptomatic without numbness, tingling, burning or pain in the feet, ages 10-18.
  • Fasting blood glucose greater than 120 mg at the time of initial diagnosis or a HbA1C greater than 6.0 at the time of the initial diagnosis will indicate that individual is to be considered a diabetic.
  • BMI ranges of acceptability are greater than 5th percentile and less than 85th percentile.

Exclusion criteria

Exclusion Criteria:

  • Symptomatic with neurological symptoms of numbness, tingling, burning or pain in the feet of either controls or diabetic subjects.
  • On medications that can produce peripheral neuropathy, i.e. statins (Lipitor), Dilantin, anti-neoplastic drugs.
  • Unable to understand informed consent, i.e. mental retardation, psychosis, communicative impairment, language barrier.
  • Morbid obesity - maximum BMI greater than 85th percentile.
  • Underweight status less than 5th percentile BMI.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
40 participants (estimated)
06

Study locations

1 site
  • Michael I. Weintraub, MD
    Briarcliff Manor, New York 10510, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00466778
Lead sponsor
Weintraub, Michael I., MD, FACP, FAAN
First posted
Apr 27, 2007
Start date
Apr 2007
Last update
Sep 21, 2007

Study contacts

Richard A. Noto, MD
study chair · Phelps Memorial Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Peripheral Nervous System Diseases →

Other studies from this sponsor

Weintraub, Michael I., MD, FACP, FAAN

Start the discussion