The Effect of Bariatric Surgery on Peripheral Nerve Function and Axonal Regeneration (BAR)
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|ClinicalTrials.gov Identifier: NCT02218866|
Recruitment Status : Completed
First Posted : August 18, 2014
Last Update Posted : April 10, 2018
|Condition or disease|
|Peripheral Neuropathy Obesity|
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.
|Study Type :||Observational|
|Actual Enrollment :||205 participants|
|Official Title:||The Effect of Bariatric Surgery on Peripheral Nerve Function and Axonal Regeneration|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||December 31, 2017|
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:
Group 3 will comprise of individuals who are not overweight. Participants in this group will undergo a similar evaluation to Group 2.
- Change in reinnervation capacity [ Time Frame: 4 - 1 months prior to bariatric surgery, compared to 9 - 12 months after surgery ]
- 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 ]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 [ Time Frame: Baseline to 12 months after bariatric surgery ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218866
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||A. Gordon Smith, MD||University of Utah|