Peripheral NeuropathyNCT00466778
Autonomic Nervous System Dysfunction and Peripheral Neuropathy in a Cohort of Asymptomatic Juvenile Diabetic Patients (Type I): A Case-Controlled Study
An observational study of Peripheral Neuropathy and Autonomic Neuropathy, run by Weintraub, Michael I., MD, FACP, FAAN at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Neuropathy, Autonomic Neuropathy
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael I. Weintraub, MD
Briarcliff Manor, New York, 10510
About this study
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.
Read the 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.
- Conditions
- Peripheral Neuropathy, Autonomic Neuropathy
- Medical subject headings
- Peripheral Nervous System Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weintraub, Michael I., MD, FACP, FAAN
- Investigators
- Richard A. Noto, MD, Study chair, Phelps Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466778
- Sponsor's protocol ID
- 2007425
- Status last verified
- Sep 2007
- First submitted
- 25 Apr 2007
- Last updated
- 21 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Nervous System Dysfunction and Peripheral Neuropathy in a Cohort of Asymptomatic Juvenile Diabetic Patients (Type I): A Case-Controlled Study
- ClinicalTrials.gov ID
- NCT00466778
- Acronym / sponsor ID
- 2007425
- Conditions
- Peripheral Neuropathy, Autonomic Neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Weintraub, Michael I., MD, FACP, FAAN
- Study start
- Apr 2007
- First posted
- 27 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2007.
Related trials for Peripheral Neuropathy
Not yet recruiting
Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Effects of Perturbation-Based Versus Conventional Balance Training on Reactive Stepping Ability in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard A. Noto, MD study chair
Phelps Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Neuropathy and Autonomic Neuropathy, run by Weintraub, Michael I., MD, FACP, FAAN at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2007; AzTrials last refreshed its copy on 31 Oct 2026.