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

Obesity Clinical Trial

— BAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02218866
• Other study ID #: BAR-UofU
• Status: Completed
• First received: August 4, 2014
• Last updated: April 8, 2018
• Start date: January 2012
• Est. completion date: December 31, 2017

Study information

• Verified date: August 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in reinnervation capacity		4 - 1 months prior to bariatric surgery, compared to 9 - 12 months after surgery
Secondary	Change in Utah Early Neuropathy Scale (UENS)		Baseline to 12 months after bariatric surgery
Secondary	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.	Baseline to 12 months after bariatric surgery
Secondary	Change in nerve fiber density		Baseline to 12 months after bariatric surgery