Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466778
Status:
COMPLETED
Last Update Posted:
2007-09-21
First Post:
2007-04-25
Brief Title:
Autonomic Nervous System Dysfunction and Peripheral Neuropathy in a Cohort of Asymptomatic Juvenile Diabetic Patients Type I A Case-Controlled Study
Sponsor:
Weintraub Michael I MD FACP FAAN
Organization:
Weintraub Michael I MD FACP FAAN
Study Overview
Official Title:
Autonomic Nervous System Dysfunction and Peripheral Neuropathy in a Cohort of Asymptomatic Juvenile Diabetic Patients Type I A Case-Controlled Study
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 agesex 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 subjects 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None