Autonomic Nervous System Dysfunction and Peripheral Neuropathy in a Cohort of Asymptomatic Juvenile Diabetic Patients (Type I): A Case-Controlled Study
Completed
Conditions studied: Peripheral Neuropathy, Autonomic Neuropathy
In brief
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.
Key facts
- Study ID
- NCT00466778
- Run by
- Weintraub, Michael I., MD, FACP, FAAN
- People needed
- 40
- Starts
- 2007-04-01
- Last updated by the study team
- 2007-09-21
Who can join
Age: 10 and older, up to 18. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Michael I. Weintraub, MD — Briarcliff Manor, New York, United States
Full record on ClinicalTrials.gov
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