Effect of Exercise and Surgical Weight Loss on Polyneuropathy

NCT ID: NCT03617185

Last Updated: 2025-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-12
• Study Completion Date: 2024-08-01

Brief 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.

Detailed 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.

Conditions

Polyneuropathies; Obesity; Bariatric Surgery Candidate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bariatric Surgery/HIIT

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.

Group Type: ACTIVE_COMPARATOR

High Intensity Interval Training (HIIT)

Intervention Type: OTHER

Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.

Bariatric surgery

Intervention Type: PROCEDURE

Patients will undergo bariatric surgery as part of their routine care

Bariatric Surgery/Routine Exercise

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

Group Type: ACTIVE_COMPARATOR

Routine Exercise

Intervention Type: OTHER

Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).

Bariatric surgery

Intervention Type: PROCEDURE

Patients will undergo bariatric surgery as part of their routine care

No Bariatric Surgery/HIIT

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.

Group Type: ACTIVE_COMPARATOR

High Intensity Interval Training (HIIT)

Intervention Type: OTHER

Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.

No Bariatric Surgery/Routine Exercise

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

Group Type: ACTIVE_COMPARATOR

Routine Exercise

Intervention Type: OTHER

Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).

Interventions

High Intensity Interval Training (HIIT)

Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.

Intervention Type: OTHER

Routine Exercise

Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).

Intervention Type: OTHER

Bariatric surgery

Patients will undergo bariatric surgery as part of their routine care

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Brian Callaghan

Fovette E Dush Early Career Professor and Assistant Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian C Callaghan, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan, Department of Neurology

Locations

University Of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

Reynolds EL, Koenig F, Watanabe M, Kwiatek A, Elafros MA, Stino A, Henderson D, Herrmann DN, Feldman EL, Callaghan BC. Comparison of intraepidermal nerve fiber density and confocal corneal microscopy for neuropathy. Ann Clin Transl Neurol. 2024 Dec;11(12):3115-3124. doi: 10.1002/acn3.52218. Epub 2024 Oct 12.

Reference Type: DERIVED

PMID: 39394845 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01DK115687-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00143541

Identifier Type: -

Identifier Source: org_study_id