Clinical trial NCT03617185: Effect of Exercise and Surgical Weight Loss on Polyneuropathy
Official title: The Effect of High Intensity Interval Training and Surgical Weight Loss on Distal Symmetric Polyneuropathy Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polyneuropathies
Obesity
Bariatric Surgery Candidate
Keywords: Metabolic syndrome
Exercise
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-08-06
Enrollment: 140
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be assigned to one of 4 arms, bariatric surgery/HIIT, bariatric surgery/routine exercise, no bariatric surgery/HIIT, no bariatric surgery/routine exercise.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Intraepidermal Nerve Fiber Density (IENFD) at the proximal thigh
timeFrame: Baseline, 3 months, 12 months and 24 months
Secondary outcomes:
measure: Change in Intraepidermal Nerve Fiber Density (IENFD) at distal leg.
timeFrame: Baseline, 3 months, 12 months and 24 months
measure: Corneal Confocal Microscopy (CCM)
timeFrame: Baseline, 3 month, 12 months and 24 months
measure: 24-2 Frequency Doubling Technology (FDT)
timeFrame: Baseline, 3 month, 12 months and 24 months
measure: Retinal Fundus Photography
timeFrame: Baseline, 3 month, 12 months and 24 months
measure: Nerve Conduction Study (NCS)
timeFrame: Baseline and 24 months
measure: Cardiac Autonomic Neuropathy Testing
timeFrame: Baseline and 24 months
measure: Cardiac Autonomic Neuropathy Testing
timeFrame: Baseline and 24 months
measure: Cardiac Autonomic Neuropathy Testing
timeFrame: Baseline and 24 months
measure: Incidence of polyneuropathy as defined by the Toronto definition of probable neuropathy
timeFrame: 24 months
measure: Michigan Neuropathy Screening Instrument (MNSI)
timeFrame: Baseline, 3 month, 12 months and 24 months
measure: Utah Early Neuropathy Score
timeFrame: Baseline, 3 month, 12 months and 24 months
measure: Modified Toronto Neuropathy Score (mTNS)
timeFrame: Baseline, 3 month, 12 months and 24 months
measure: Survey of Autonomic Symptoms (SAS)
timeFrame: Baseline, 3 month, 12 months and 24 months
measure: Diabetic Neuropathy Score (DNS)
timeFrame: Baseline, 3 month, 12 months and 24 months
measure: Short Form McGill Pain Questionnaire
timeFrame: Baseline, 3 months, 12 months, 24 months
measure: Numerical Rating Scale for pain
timeFrame: Baseline, 3 months, 12 months, 24 months
measure: Neuropathy Quality of Life (NeuroQOL)
timeFrame: Baseline, 3 months, 12 months, and 24 months
measure: Berg Balance Scale
timeFrame: Baseline, 3 months, 12 months, and 24 months
measure: 8 Foot Get Up and Go Test
timeFrame: Baseline, 3 months, 12 months, and 24 months
measure: Modified Falls Efficacy Scale
timeFrame: Baseline, 3 months, 12 months, and 24 months
measure: Neurothesiometer
timeFrame: Baseline, 3 months, 12 months, and 24 months
measure: NIH Toolbox Cognitive Battery
timeFrame: Baseline and at 24 months
measure: Rey Auditory Verbal Learning Test
timeFrame: Baseline and at 24 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University Of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan, Department of Neurology
name: Brian C Callaghan, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: