This trial is active, not recruiting.

Conditions peripheral neuropathy, obesity
Sponsor University of Utah
Collaborator American Diabetes Association
Start date January 2012
End date July 2017
Trial size 205 participants
Trial identifier NCT02218866, BAR-UofU


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
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.
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 will comprise of individuals who are not overweight. Participants in this group will undergo a similar evaluation to Group 2.

Primary Outcomes

Change in reinnervation capacity
time frame: 4 - 1 months prior to bariatric surgery, compared to 9 - 12 months after surgery

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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Age 18-80 years old - Subjects must fulfill criteria for bariatric surgery. Exclusion Criteria: - 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.

Additional Information

Official title The Effect of Bariatric Surgery on Peripheral Nerve Function and Axonal Regeneration
Principal investigator A. Gordon Smith, MD
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 1. characterize peripheral nerve function and cutaneous nerve structure in obese bariatric surgery candidates; 2. evaluate peripheral nerve regeneration capacity (and other nerve function measures) before and after bariatric surgery in obese subjects with no or mild neuropathy; 3. examine the relationship between ectopic lipid accumulation, lipotoxic mediators, neuropathy and regeneration capacity in surgical candidates before and one year after surgery.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Utah.