Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-02-02 @ 11:04 AM
Study NCT ID:
NCT02218866
Status:
COMPLETED
Last Update Posted:
2018-04-10
First Post:
2014-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Bariatric Surgery on Peripheral Nerve Function and Axonal Regeneration
Sponsor:
University of Utah
Organization:
Study Overview
Official Title:
The Effect of Bariatric Surgery on Peripheral Nerve Function and Axonal Regeneration
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BAR
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: