The Effect of Bariatric Surgery on Peripheral Nerve Function and Axonal Regeneration

Completed

• Conditions: Obesity; Peripheral Neuropathy

• Registration Number: NCT02218866
• Lead Sponsor: University of Utah

Brief 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.

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2014-08-04
• Study First Submitted QC: 2014-08-14
• Study First Posted: 2014-08-18
• Status Verified: 2016-08
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Last Update Submitted: 2018-04-08
• Last Update Posted: 2018-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

• Age 18-80 years old
• Subjects must fulfill criteria for bariatric surgery.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in reinnervation capacity	4 - 1 months prior to bariatric surgery, compared to 9 - 12 months after surgery

Secondary Outcome Measures

Name	Time	Method
Change in Utah Early Neuropathy Scale (UENS)	Baseline to 12 months after bariatric surgery
Change in Nerve Conduction Study measures	Baseline to 12 months after bariatric surgery	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.
Change in nerve fiber density	Baseline to 12 months after bariatric surgery

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States