Peripheral NeuropathyBARNCT02218866
The Effect of Bariatric Surgery on Peripheral Nerve Function and Axonal Regeneration
An observational study of Peripheral Neuropathy and Obesity, run by University of Utah at 1 site in United States.
Trial summary
The goal of this research is understand if obesity is a major factor for neuropathy development in patients with and without Type 2 diabetes. This study will examine the relationship between weight, metabolism, and nerve function and regeneration. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Neuropathy, Obesity
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to 31 Dec 2017
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited through bariatric surgery clinics in the local area.
Who may be able to join
- Age 18-80 years old
- Subjects must fulfill criteria for bariatric surgery.
Who cannot join
- History of foot ulceration or neurogenic arthropathy
- Family history of non-diabetic neuropathy in a first-degree family member.
- Presence of any disease known to be associated with peripheral neuropathy including but not limited to vitamin deficiency, toxin exposure, paraproteinemia, heavy alcohol use, hepatitis C, HIV.
- Coumadin use.
- Inability to understand or cooperate with the procedures of the trial.
- Known history of sensitivity to capsaicin products.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this research is understand if obesity is a major factor for neuropathy development in patients with and without Type 2 diabetes. This study will examine the relationship between weight, metabolism, and nerve function and regeneration.
Read the detailed description
Peripheral neuropathy causes progressive injury to the longest nerves of the body, starting in the toes, then progressing slowly up the leg. Neuropathy often causes pain, numbness, and weakness if the feet and can lead to reduced mobility, foot ulcers, and even amputation. The most common cause is diabetes, but work at the University of Utah finds that prediabetes and other consequences of obesity, including abnormal cholesterol levels, may be associated with neuropathy. Research has shown that these risk factors may damage nerves and interfere with the ability of nerves to grow back after an injury.
This study aims to
- characterize peripheral nerve function and cutaneous nerve structure in obese bariatric surgery candidates;
- evaluate peripheral nerve regeneration capacity (and other nerve function measures) before and after bariatric surgery in obese subjects with no or mild neuropathy;
- examine the relationship between ectopic lipid accumulation, lipotoxic mediators, neuropathy and regeneration capacity in surgical candidates before and one year after surgery.
- Conditions
- Peripheral Neuropathy, Obesity
- Keywords
- Bariatric surgery, Obesity, Neuropathy
- Medical subject headings
- Peripheral Nervous System Diseases, Obesity
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 |
|---|---|---|
| Group 1 | All participants will be examined by a neurologist to test sensation, reflexes, and strength and complete a few questionnaires. Tests will be performed to measure nerve function and small punch skin biopsies will be taken to assess nerve fiber density. Blood and urine tests will measure various markers of interest. Participants will be seen before and after their bariatric surgery. | |
| Group 2 | In addition to the procedures described for Group 1, participants in Group 2 will have the following procedures: * During bariatric surgery, a small biopsy from the liver and abdominal fat will be taken to examine how fat is processed within the body. * At the first visit, after a skin biopsy is taken, a small capsaicin patch will be placed on the lower thigh. The patch will remain in place for 48 hours and will cause the nerves in the immediate area to pull back from the skin. A biopsy will be taken from the patch area 48 hours, 1 month, and 3 months after the initial biopsy. This procedure will be repeated after surgery. * MRIs may be performed before and after bariatic surgery. * Participants may be asked to complete additional tests to evaluate nerve function | |
| Group 3 | Group 3 will comprise of individuals who are not overweight. Participants in this group will undergo a similar evaluation to Group 2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in reinnervation capacity
Measured: 4 - 1 months prior to bariatric surgery, compared to 9 - 12 months after surgery
Secondary outcomes (3)
Change in Utah Early Neuropathy Scale (UENS)
Measured: Baseline to 12 months after bariatric surgery
Change in Nerve Conduction Study measures
Nerve Conduction Study is a procedure routinely used in the diagnosis of neuropathy. Measures will include Sural sensory and Peroneal motor amplitudes and conduction velocities.
Measured: Baseline to 12 months after bariatric surgery
Change in nerve fiber density
Measured: Baseline to 12 months after bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startJan 2012
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
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.
- More trials run by University of UtahThe 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
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Gordon Smith, University of Utah
- Investigators
- A. Gordon Smith, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218866
- Sponsor's protocol ID
- BAR-UofU
- Acronym
- BAR
- Status last verified
- Aug 2016
- First submitted
- 4 Aug 2014
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bariatric Surgery on Peripheral Nerve Function and Axonal Regeneration
- ClinicalTrials.gov ID
- NCT02218866
- Acronym / sponsor ID
- BAR / BAR-UofU
- Conditions
- Peripheral Neuropathy, Obesity
- Keywords
- Bariatric surgery, Obesity, Neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Jan 2012
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 18 Aug 2014 (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.
The goal of this research is understand if obesity is a major factor for neuropathy development in patients with and without Type 2 diabetes. This study will examine the relationship between weight, metabolism, and nerve function and regeneration.
Detailed description
Peripheral neuropathy causes progressive injury to the longest nerves of the body, starting in the toes, then progressing slowly up the leg. Neuropathy often causes pain, numbness, and weakness if the feet and can lead to reduced mobility, foot ulcers, and even amputation. The most common cause is diabetes, but work at the University of Utah finds that prediabetes and other consequences of obesity, including abnormal cholesterol levels, may be associated with neuropathy. Research has shown that these risk factors may damage nerves and interfere with the ability of nerves to grow back after an injury.
This study aims to
- characterize peripheral nerve function and cutaneous nerve structure in obese bariatric surgery candidates;
- evaluate peripheral nerve regeneration capacity (and other nerve function measures) before and after bariatric surgery in obese subjects with no or mild neuropathy;
- examine the relationship between ectopic lipid accumulation, lipotoxic mediators, neuropathy and regeneration capacity in surgical candidates before and one year after surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –All participants will be examined by a neurologist to test sensation, reflexes, and strength and complete a few questionnaires. Tests will be performed to measure nerve function and small punch skin biopsies will be taken to assess nerve fiber density. Blood and urine tests will measure various markers of interest. Participants will be seen before and after their bariatric surgery. |
| Group 2 | – | –In addition to the procedures described for Group 1, participants in Group 2 will have the following procedures: * During bariatric surgery, a small biopsy from the liver and abdominal fat will be taken to examine how fat is processed within the body. * At the first visit, after a skin biopsy is taken, a small capsaicin patch will be placed on the lower thigh. The patch will remain in place for 48 hours and will cause the nerves in the immediate area to pull back from the skin. A biopsy will be taken from the patch area 48 hours, 1 month, and 3 months after the initial biopsy. This procedure will be repeated after surgery. * MRIs may be performed before and after bariatic surgery. * Participants may be asked to complete additional tests to evaluate nerve function |
| Group 3 | – | –Group 3 will comprise of individuals who are not overweight. Participants in this group will undergo a similar evaluation to Group 2. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited through bariatric surgery clinics in the local area.
Key inclusion criteria (2 listed)
- Age 18-80 years old
- Subjects must fulfill criteria for bariatric surgery.
Key exclusion criteria (6 listed)
- History of foot ulceration or neurogenic arthropathy
- Family history of non-diabetic neuropathy in a first-degree family member.
- Presence of any disease known to be associated with peripheral neuropathy including but not limited to vitamin deficiency, toxin exposure, paraproteinemia, heavy alcohol use, hepatitis C, HIV.
- Coumadin use.
- Inability to understand or cooperate with the procedures of the trial.
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
Change in reinnervation capacity
Time frame: 4 - 1 months prior to bariatric surgery, compared to 9 - 12 months after surgery
3 secondary outcomes
Change in Utah Early Neuropathy Scale (UENS)
Time frame: Baseline to 12 months after bariatric surgery
Change in Nerve Conduction Study measures
Time frame: Baseline to 12 months after bariatric surgery
Change in nerve fiber density
Time frame: Baseline to 12 months after bariatric surgery
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 10 Apr 2018.
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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.
A. Gordon Smith, MD principal investigator
University of Utah
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 Obesity, run by University of Utah 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 2 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 10 Apr 2018. 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?
Change in reinnervation capacity (time frame: 4 - 1 months prior to bariatric surgery, compared to 9 - 12 months after surgery). 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 10 Apr 2018.