Status:
COMPLETED
Autonomic Nervous System Dysfunction and Peripheral Neuropathy in a Cohort of Asymptomatic Juvenile Diabetic Patients (Type I): A Case-Controlled Study
Lead Sponsor:
Weintraub, Michael I., MD, FACP, FAAN
Conditions:
Peripheral Neuropathy
Autonomic Neuropathy
Eligibility:
All Genders
10-18 years
Brief 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...
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 associat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00466778
Start Date
April 1 2007
Last Update
September 21 2007
Active Locations (1)
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1
Michael I. Weintraub, MD
Briarcliff Manor, New York, United States, 10510