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Completed

NCT Number: NCT02218866

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah

Salt Lake City, Utah, 84132, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in reinnervation capacity

    Time frame: 4 - 1 months prior to bariatric surgery, compared to 9 - 12 months after surgery

Secondary outcomes

  1. Change in Utah Early Neuropathy Scale (UENS)

    Time frame: Baseline to 12 months after bariatric surgery

  2. Change in Nerve Conduction Study measures

    Time frame: 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.

  3. Change in nerve fiber density

    Time frame: Baseline to 12 months after bariatric surgery

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • American Diabetes Association

Registry information

Acronym: BAR

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Aug 18, 2014
Registry last updated
Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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