Diabetic Peripheral NeuropathyNCT00835757
Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy
An observational study of Diabetic Peripheral Neuropathy, run by University of Michigan at 1 site in United States.
Trial summary
This study aims to validate magnetic resonance imaging and diffusion tensor imaging (MRI/ DTI) analysis as a non-invasive method for the assessment of myelinated nerve fibers loss in diabetic peripheral neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2012
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two groups of 25 subjects each will be studied: subjects with confirmed diabetic peripheral neuropathy (DPN) and age- and sex-matched healthy controls.
Who may be able to join
- Presence of diabetes mellitus diagnosed for more than 6 months as defined by the World Health Organization Classification.
- Presence of confirmed DPN as defined below.
- Age between 18-70 years.
- Have no risk factors for other non-diabetic neuropathies (as determined by medical history, family history, history of medications, occupational history, history of exposure to toxins, physical and neurological examinations).
- Willingness to provide informed consent and cooperate with the medical procedures for the study.
- Age-matched non-obese (BMI < 30) control subjects
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- Normal glucose tolerance
- Normal blood pressure
- Normal lipid profile
- Free of any causes of neuropathy as described above.
Who cannot join
- Nursing mothers or pregnant women (excluded by a positive pregnancy test).
- Patients with a history of previous kidney, pancreas or cardiac transplantation.
- Patients with a past history of neuropathy (independent of diabetes), or with a disease known to be associated with neuropathy (e.g. end stage renal disease, hepatitis C, systemic lupus erythematosus).
- Participation in an experimental medication trial within 3 months of starting the study.
- Subjects with implantable cardioverter defibrillators and other devices that would preclude MRI scanning.
- Subjects who are unable or unwilling to comply with the experimental protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy"
This study aims to validate magnetic resonance imaging and diffusion tensor imaging (MRI/ DTI) analysis as a non-invasive method for the assessment of myelinated nerve fibers loss in diabetic peripheral neuropathy.
- Conditions
- Diabetic Peripheral Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Diabetic peripheral neuropathy | |
| 2 | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in means between DTI parameters (FA and MD) measured in the sural nerve between subjects with DPN and healthy control subjects.
Measured: 12-18 months
Secondary outcomes (1)
The association between DTI parameters and clinical and electrophysiological measures of DPN
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startSep 2008
- Primary completionJun 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Principal investigator, Rodica Pop-Busui, University of Michigan
- Investigators
- Rodica Pop-Busui, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835757
- Sponsor's protocol ID
- 1-2008-1025
- Other IDs
- JDRF 1-2008-1025
- Status last verified
- Dec 2013
- First submitted
- 2 Feb 2009
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy"
- ClinicalTrials.gov ID
- NCT00835757
- Acronym / sponsor ID
- 1-2008-1025
- Conditions
- Diabetic Peripheral Neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- Sep 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Feb 2009 (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 study aims to validate magnetic resonance imaging and diffusion tensor imaging (MRI/ DTI) analysis as a non-invasive method for the assessment of myelinated nerve fibers loss in diabetic peripheral neuropathy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Diabetic peripheral neuropathy |
| 2 | – | –Healthy controls |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two groups of 25 subjects each will be studied: subjects with confirmed diabetic peripheral neuropathy (DPN) and age- and sex-matched healthy controls.
Key inclusion criteria (10 listed)
- Presence of diabetes mellitus diagnosed for more than 6 months as defined by the World Health Organization Classification.
- Presence of confirmed DPN as defined below.
- Age between 18-70 years.
- Have no risk factors for other non-diabetic neuropathies (as determined by medical history, family history, history of medications, occupational history, history of exposure to toxins, physical and neurological examinations).
- Willingness to provide informed consent and cooperate with the medical procedures for the study.
Key exclusion criteria (6 listed)
- Nursing mothers or pregnant women (excluded by a positive pregnancy test).
- Patients with a history of previous kidney, pancreas or cardiac transplantation.
- Patients with a past history of neuropathy (independent of diabetes), or with a disease known to be associated with neuropathy (e.g. end stage renal disease, hepatitis C, systemic lupus erythematosus).
- Participation in an experimental medication trial within 3 months of starting the study.
- Subjects with implantable cardioverter defibrillators and other devices that would preclude MRI scanning.
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
The difference in means between DTI parameters (FA and MD) measured in the sural nerve between subjects with DPN and healthy control subjects.
Time frame: 12-18 months
1 secondary outcome
The association between DTI parameters and clinical and electrophysiological measures of DPN
Time frame: 12-18 months
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 17 Dec 2013.
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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.
Rodica Pop-Busui, MD, PhD principal investigator
University of Michigan
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 Diabetic Peripheral Neuropathy, run by University of Michigan 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 10 inclusion and 6 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 17 Dec 2013. 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.
What does the primary outcome measure?
The difference in means between DTI parameters (FA and MD) measured in the sural nerve between subjects with DPN and healthy control subjects. (time frame: 12-18 months). It is what the study was designed to measure, not a finding.
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 17 Dec 2013.