Effect of Exercise and Surgical Weight Loss on Polyneuropathy

University of Michigan

Status: Completed

Conditions: Polyneuropathies; Bariatric Surgery Candidate; Obesity

Treatments: Other: Routine Exercise; Other: High Intensity Interval Training (HIIT); Procedure: Bariatric surgery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03617185

1R01DK115687-01A1 (U.S. NIH Grant/Contract)

HUM00143541

Details and patient eligibility

About

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.

Full description

The length of this study, including screening is approximately 24 months. Patients at Bariatric Surgery Clinics 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.

Enrollment: 140 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 4 patient groups

Bariatric Surgery/HIIT

Active Comparator group

Description:

Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.

Treatment:

Procedure: Bariatric surgery

Other: High Intensity Interval Training (HIIT)

Bariatric Surgery/Routine Exercise

Active Comparator group

Description:

Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.

Treatment:

Procedure: Bariatric surgery

Other: Routine Exercise

No Bariatric Surgery/HIIT

Active Comparator group

Description:

Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.

Treatment:

Other: High Intensity Interval Training (HIIT)

No Bariatric Surgery/Routine Exercise

Active Comparator group

Description:

Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.

Treatment:

Other: Routine Exercise