Effect of Exercise and Surgical Weight Loss on Polyneuropathy (NCT03617185) | Clinical Trial Compass
CompletedNot Applicable
Effect of Exercise and Surgical Weight Loss on Polyneuropathy
United States140 participantsStarted 2018-07-27
Plain-language summary
The purpose of this research study is to evaluate how exercise and surgical weight loss affect how likely an individual is to develop peripheral neuropathy and other neurologic complications.
Who can participate
Age range40 Years
SexALL
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Inclusion Criteria:
* Attending a bariatric surgery clinic
* BMI \> 35 with one comorbid condition present or BMI \> 40 without comorbid conditions present
* Willing and capable to sign the Institutional Review Board (IRB) approved consent form and cooperate with the medical procedures for the study duration
* Willing to accept random treatment assignment to HIIT or routine exercise counseling
Exclusion Criteria:
* History of distal symmetric polyneuropathy (DSP) from causes other than diabetes and/or the metabolic syndrome as determined through medical history, family history, history of medications, occupational history, history of exposure to toxins, physical and neurological examinations;
* Use of warfarin, heparin, or other anticoagulants, which would increase the risk of complications from skin biopsy
* Contraindication to HIIT participation including a failed exercise stress test
* Participation in an experimental medication trial within 3 months of starting the study
* Undergoing therapy for malignant disease other than basal-cell or squamous-cell skin cancer
* Medical or psychiatric reason for not being a surgical candidate
* Requiring a walking assist device;
* Currently smoking
What they're measuring
1
Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh
Timeframe: Baseline, 3 months, 12 months and 24 months