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Effect of Exercise and Surgical Weight Loss on Polyneuropathy

Primary Purpose

Polyneuropathies, Obesity, Bariatric Surgery Candidate

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Intensity Interval Training (HIIT)
Routine Exercise
Bariatric surgery
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polyneuropathies focused on measuring Metabolic syndrome, Exercise

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Bariatric Surgery/HIIT

Bariatric Surgery/Routine Exercise

No Bariatric Surgery/HIIT

No Bariatric Surgery/Routine Exercise

Arm 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.

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

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.

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

Outcomes

Primary Outcome Measures

Change in Intraepidermal Nerve Fiber Density (IENFD) at the proximal thigh
As assessed by 3mm skin biopsies.Linear mixed effects regression modeling will account for multiple time points of the same measure.

Secondary Outcome Measures

Change in Intraepidermal Nerve Fiber Density (IENFD) at distal leg.
As assessed by 3mm skin biopsies. Linear mixed effects regression modeling will account for multiple time points of the same measure.
Corneal Confocal Microscopy (CCM)
24-2 Frequency Doubling Technology (FDT)
Retinal Fundus Photography
Nerve Conduction Study (NCS)
Sural, peroneal, and tibial nerves.
Cardiac Autonomic Neuropathy Testing
Deep breathing-E:I ratio
Cardiac Autonomic Neuropathy Testing
Postural change-30:15 ratio
Cardiac Autonomic Neuropathy Testing
Valsalva- Valsalva ratio
Incidence of polyneuropathy as defined by the Toronto definition of probable neuropathy
Toronto definition of probable neuropathy-2 out of 3 of abnormal sensory examination, reflexes, and symptoms.
Michigan Neuropathy Screening Instrument (MNSI)
Utah Early Neuropathy Score
Scale 0-48, higher is more severe polyneuropathy
Modified Toronto Neuropathy Score (mTNS)
Range 0-33, higher is more severe polyneuropathy
Survey of Autonomic Symptoms (SAS)
Diabetic Neuropathy Score (DNS)
Range 0-4, >/=1 indicates polyneuropathy
Short Form McGill Pain Questionnaire
Numerical Rating Scale for pain
Range 0-10, higher score indicates more pain
Neuropathy Quality of Life (NeuroQOL)
Berg Balance Scale
Range 0-56, higher score indicates less likely to fall
8 Foot Get Up and Go Test
Modified Falls Efficacy Scale
Range 0-140, higher score indicates less likely to fall
Neurothesiometer
NIH Toolbox Cognitive Battery
Rey Auditory Verbal Learning Test

Full Information

First Posted
July 14, 2018
Last Updated
March 23, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03617185
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyneuropathies, Obesity, Bariatric Surgery Candidate
Keywords
Metabolic syndrome, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
The neuropathy outcomes assessors will be blinded to the exercise protocol that the patients are randomized to and the surgical status for the duration of the study.
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bariatric Surgery/HIIT
Arm Type
Active Comparator
Arm 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.
Arm Title
Bariatric Surgery/Routine Exercise
Arm Type
Active Comparator
Arm Description
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Arm Title
No Bariatric Surgery/HIIT
Arm Type
Active Comparator
Arm 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.
Arm Title
No Bariatric Surgery/Routine Exercise
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
High Intensity Interval Training (HIIT)
Intervention Description
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
Intervention Name(s)
Routine Exercise
Intervention Description
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
Procedure
Intervention Name(s)
Bariatric surgery
Intervention Description
Patients will undergo bariatric surgery as part of their routine care
Primary Outcome Measure Information:
Title
Change in Intraepidermal Nerve Fiber Density (IENFD) at the proximal thigh
Description
As assessed by 3mm skin biopsies.Linear mixed effects regression modeling will account for multiple time points of the same measure.
Time Frame
Baseline, 3 months, 12 months and 24 months
Secondary Outcome Measure Information:
Title
Change in Intraepidermal Nerve Fiber Density (IENFD) at distal leg.
Description
As assessed by 3mm skin biopsies. Linear mixed effects regression modeling will account for multiple time points of the same measure.
Time Frame
Baseline, 3 months, 12 months and 24 months
Title
Corneal Confocal Microscopy (CCM)
Time Frame
Baseline, 3 month, 12 months and 24 months
Title
24-2 Frequency Doubling Technology (FDT)
Time Frame
Baseline, 3 month, 12 months and 24 months
Title
Retinal Fundus Photography
Time Frame
Baseline, 3 month, 12 months and 24 months
Title
Nerve Conduction Study (NCS)
Description
Sural, peroneal, and tibial nerves.
Time Frame
Baseline and 24 months
Title
Cardiac Autonomic Neuropathy Testing
Description
Deep breathing-E:I ratio
Time Frame
Baseline and 24 months
Title
Cardiac Autonomic Neuropathy Testing
Description
Postural change-30:15 ratio
Time Frame
Baseline and 24 months
Title
Cardiac Autonomic Neuropathy Testing
Description
Valsalva- Valsalva ratio
Time Frame
Baseline and 24 months
Title
Incidence of polyneuropathy as defined by the Toronto definition of probable neuropathy
Description
Toronto definition of probable neuropathy-2 out of 3 of abnormal sensory examination, reflexes, and symptoms.
Time Frame
24 months
Title
Michigan Neuropathy Screening Instrument (MNSI)
Time Frame
Baseline, 3 month, 12 months and 24 months
Title
Utah Early Neuropathy Score
Description
Scale 0-48, higher is more severe polyneuropathy
Time Frame
Baseline, 3 month, 12 months and 24 months
Title
Modified Toronto Neuropathy Score (mTNS)
Description
Range 0-33, higher is more severe polyneuropathy
Time Frame
Baseline, 3 month, 12 months and 24 months
Title
Survey of Autonomic Symptoms (SAS)
Time Frame
Baseline, 3 month, 12 months and 24 months
Title
Diabetic Neuropathy Score (DNS)
Description
Range 0-4, >/=1 indicates polyneuropathy
Time Frame
Baseline, 3 month, 12 months and 24 months
Title
Short Form McGill Pain Questionnaire
Time Frame
Baseline, 3 months, 12 months, 24 months
Title
Numerical Rating Scale for pain
Description
Range 0-10, higher score indicates more pain
Time Frame
Baseline, 3 months, 12 months, 24 months
Title
Neuropathy Quality of Life (NeuroQOL)
Time Frame
Baseline, 3 months, 12 months, and 24 months
Title
Berg Balance Scale
Description
Range 0-56, higher score indicates less likely to fall
Time Frame
Baseline, 3 months, 12 months, and 24 months
Title
8 Foot Get Up and Go Test
Time Frame
Baseline, 3 months, 12 months, and 24 months
Title
Modified Falls Efficacy Scale
Description
Range 0-140, higher score indicates less likely to fall
Time Frame
Baseline, 3 months, 12 months, and 24 months
Title
Neurothesiometer
Time Frame
Baseline, 3 months, 12 months, and 24 months
Title
NIH Toolbox Cognitive Battery
Time Frame
Baseline and at 24 months
Title
Rey Auditory Verbal Learning Test
Time Frame
Baseline and at 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian C Callaghan, MD, MS
Organizational Affiliation
University of Michigan, Department of Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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Effect of Exercise and Surgical Weight Loss on Polyneuropathy

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