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

NCT00466778 | Completed

• 1 other identifier: 2007425
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Peripheral Neuropathy; Autonomic Neuropathy

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• Weintraub, Michael I., MD, FACP, FAAN: lead

Study Sites (1)

Michael I. Weintraub, MD

Briarcliff Manor, New York, 10510, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Richard A. Noto, MD

  Phelps Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: April 25, 2007
• First Posted: April 27, 2007
• Study Start: April 1, 2007
• Last Updated: September 21, 2007

Record last verified: 2007-09

Locations

US (1)