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

This study has been completed.
Sponsor:
Information provided by:
Weintraub, Michael I., MD, FACP, FAAN
ClinicalTrials.gov Identifier:
NCT00466778
First received: April 25, 2007
Last updated: September 20, 2007
Last verified: September 2007
  Purpose

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.


Condition Phase
Peripheral Neuropathy
Autonomic Neuropathy
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Autonomic Nervous System Dysfunction and Peripheral Neuropathy in a Cohort of Asymptomatic Juvenile Diabetic Patients (Type I): A Case-Controlled Study

Resource links provided by NLM:


Further study details as provided by Weintraub, Michael I., MD, FACP, FAAN:

Estimated Enrollment: 40
Study Start Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466778

Locations
United States, New York
Michael I. Weintraub, MD
Briarcliff Manor, New York, United States, 10510
Sponsors and Collaborators
Weintraub, Michael I., MD, FACP, FAAN
Investigators
Study Chair: Richard A. Noto, MD Phelps Memorial Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00466778     History of Changes
Other Study ID Numbers: 2007425
Study First Received: April 25, 2007
Last Updated: September 20, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on September 16, 2014