Trial results evaluating the effect of exercise and surgical weight loss on polyneuropathy in individuals with obesity were posted on ClinicalTrials.gov on 2025-10-29. The study enrolled 140 participants to assess how these interventions affect the likelihood of developing peripheral neuropathy.
Background
Obesity is a complex chronic disease associated with various health complications, including an increased risk of peripheral neuropathy, a condition affecting the nerves outside of the brain and spinal cord. Peripheral neuropathy can lead to pain, numbness, and weakness, significantly impacting quality of life. Interventions such as exercise and surgical weight loss are known to improve overall health in individuals with obesity, and this study aimed to investigate their potential role in preventing or mitigating these neurological complications.
Trial design
This completed study, designated as Phase NA, enrolled 140 participants. The trial focused on individuals with Polyneuropathies, Obesity, and those identified as Bariatric Surgery Candidates. The research evaluated how exercise and surgical weight loss affect the likelihood of developing peripheral neuropathy and other neurologic complications. Participants were categorized into groups including Bariatric Surgery with High-Intensity Interval Training (HIIT), Bariatric Surgery with Routine Exercise, No Bariatric Surgery with HIIT, and No Bariatric Surgery with Routine Exercise. A key measurement was Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh.
Key results
The study reported several key measurements for Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh:
- For the Bariatric Surgery/HIIT group, mean IENFD values were 11.9 fibers/mm (Standard Deviation 3.9), 12.6 fibers/mm (Standard Deviation 3.9), and 11.5 fibers/mm (Standard Deviation 6.1).
- For the Bariatric Surgery/Routine Exercise group, mean IENFD values were 12.7 fibers/mm (Standard Deviation 4.4), 14.3 fibers/mm (Standard Deviation 5.0), and 14.2 fibers/mm (Standard Deviation 6.2).
- For the No Bariatric Surgery/HIIT group, mean IENFD values were 9.8 fibers/mm (Standard Deviation 4.9), 9.9 fibers/mm (Standard Deviation 4.2), and 9.2 fibers/mm (Standard Deviation 4.2).
- For the No Bariatric Surgery/Routine Exercise group, mean IENFD values were 11.0 fibers/mm (Standard Deviation 4.6), 10.6 fibers/mm (Standard Deviation 6.0), and 8.5 fibers/mm (Standard Deviation 4.4).
Key analyses were performed using t-test (2-sided) and Mixed Models Analysis:
- A t-test reported a Mean Difference (Net) of -1.98 with a 95.0% confidence interval of [-4.63, 0.74] and a p-value of 0.15.
- Another t-test reported a Mean Difference (Net) of -2.33 with a 95.0% confidence interval of [-4.98, 0.31] and a p-value of 0.08.
- A third t-test reported a Mean Difference (Net) of -1.84 with a 95.0% confidence interval of [-4.43, 0.74] and a p-value of 0.15.
- A Mixed Models Analysis reported an Interaction term for difference in slope of 0.07 with a 95.0% confidence interval of [-0.02, 0.16] and a p-value of 0.67.
- Another Mixed Models Analysis reported an Interaction term for difference in slope of 0.09 with a 95.0% confidence interval of [0.002, 0.19] and a p-value of 0.77.
- A further Mixed Models Analysis reported an Interaction term for difference in slope of 0.07 with a 95.0% confidence interval of [-0.02, 0.16] and a p-value of 0.69.
What this means
The key analyses, which included t-tests and Mixed Models Analyses, reported p-values ranging from 0.08 to 0.77. These values indicate that, based on the specific measurements and analyses presented, no statistically significant differences were observed in Intraepidermal Nerve Fiber Density at the Proximal Thigh across the different groups evaluating bariatric surgery and exercise regimens. This suggests that, within the scope of this study, the investigated interventions did not demonstrate a significant impact on this specific marker of peripheral neuropathy.
Source
The information regarding these trial results was sourced from ClinicalTrials.gov, a public registry of clinical studies. The results for the study NCT03617185, titled "Effect of Exercise and Surgical Weight Loss on Polyneuropathy", were posted on 2025-10-29 on clinicaltrials.gov.