Effect of Exercise and Surgical Weight Loss on Polyneuropathy

The length of this study, including screening is approximately 24 months. Patients in the
Adult Bariatric Surgery Clinic at the University of Michigan will be recruited for this
study. Both patients that decide to undergo bariatric surgery, and those that do not undergo
surgery will be enrolled. Patients will be randomized to either a high intensity interval
training (HIIT) or standard exercise regimen after eligibility is confirmed and the baseline
visit is complete. All patients will complete follow-up appointments at 3 month, 12 months
and 24 months. Patients that are randomized to the HIIT program will compete 2 supervised and
1 unsupervised training sessions a week for 24 months.

Inclusion Criteria:

- Attending the bariatric surgery clinic at U-M

- 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, a current exclusion for bariatric surgery at U-M