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 range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh
Timeframe: Baseline, 3 months, 12 months and 24 months