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Effect of Exercise and Surgical Weight Loss on Polyneuropathy

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ClinicalTrials.gov Identifier: NCT03617185
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Brian Callaghan, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Polyneuropathies Obesity Bariatric Surgery Candidate Other: High Intensity Interval Training (HIIT) Other: Routine Exercise Procedure: Bariatric surgery Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (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.
Primary Purpose: Treatment
Official Title: The Effect of High Intensity Interval Training and Surgical Weight Loss on Distal Symmetric Polyneuropathy Outcomes
Actual Study Start Date : July 12, 2018
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Other: 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.

Procedure: Bariatric surgery
Patients will undergo bariatric surgery as part of their routine care

Active Comparator: 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.
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).

Procedure: Bariatric surgery
Patients will undergo bariatric surgery as part of their routine care

Active Comparator: 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.
Other: 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.

Active Comparator: 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.
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).




Primary Outcome Measures :
  1. Change in Intraepidermal Nerve Fiber Density (IENFD) at the proximal thigh [ Time Frame: Baseline, 3 months, 12 months and 24 months ]
    As assessed by 3mm skin biopsies.Linear mixed effects regression modeling will account for multiple time points of the same measure.


Secondary Outcome Measures :
  1. Change in Intraepidermal Nerve Fiber Density (IENFD) at distal leg. [ Time Frame: Baseline, 3 months, 12 months and 24 months ]
    As assessed by 3mm skin biopsies. Linear mixed effects regression modeling will account for multiple time points of the same measure.

  2. Corneal Confocal Microscopy (CCM) [ Time Frame: Baseline, 3 month, 12 months and 24 months ]
  3. 24-2 Frequency Doubling Technology (FDT) [ Time Frame: Baseline, 3 month, 12 months and 24 months ]
  4. Retinal Fundus Photography [ Time Frame: Baseline, 3 month, 12 months and 24 months ]
  5. Nerve Conduction Study (NCS) [ Time Frame: Baseline and 24 months ]
    Sural, peroneal, and tibial nerves.

  6. Cardiac Autonomic Neuropathy Testing [ Time Frame: Baseline and 24 months ]
    Deep breathing-E:I ratio

  7. Cardiac Autonomic Neuropathy Testing [ Time Frame: Baseline and 24 months ]
    Postural change-30:15 ratio

  8. Cardiac Autonomic Neuropathy Testing [ Time Frame: Baseline and 24 months ]
    Valsalva- Valsalva ratio

  9. Incidence of polyneuropathy as defined by the Toronto definition of probable neuropathy [ Time Frame: 24 months ]
    Toronto definition of probable neuropathy-2 out of 3 of abnormal sensory examination, reflexes, and symptoms.

  10. Michigan Neuropathy Screening Instrument (MNSI) [ Time Frame: Baseline, 3 month, 12 months and 24 months ]
  11. Utah Early Neuropathy Score [ Time Frame: Baseline, 3 month, 12 months and 24 months ]
    Scale 0-48, higher is more severe polyneuropathy

  12. Modified Toronto Neuropathy Score (mTNS) [ Time Frame: Baseline, 3 month, 12 months and 24 months ]
    Range 0-33, higher is more severe polyneuropathy

  13. Survey of Autonomic Symptoms (SAS) [ Time Frame: Baseline, 3 month, 12 months and 24 months ]
  14. Diabetic Neuropathy Score (DNS) [ Time Frame: Baseline, 3 month, 12 months and 24 months ]
    Range 0-4, >/=1 indicates polyneuropathy

  15. Short Form McGill Pain Questionnaire [ Time Frame: Baseline, 3 months, 12 months, 24 months ]
  16. Numerical Rating Scale for pain [ Time Frame: Baseline, 3 months, 12 months, 24 months ]
    Range 0-10, higher score indicates more pain

  17. Neuropathy Quality of Life (NeuroQOL) [ Time Frame: Baseline, 3 months, 12 months, and 24 months ]
  18. Berg Balance Scale [ Time Frame: Baseline, 3 months, 12 months, and 24 months ]
    Range 0-56, higher score indicates less likely to fall

  19. 8 Foot Get Up and Go Test [ Time Frame: Baseline, 3 months, 12 months, and 24 months ]
  20. Modified Falls Efficacy Scale [ Time Frame: Baseline, 3 months, 12 months, and 24 months ]
    Range 0-140, higher score indicates less likely to fall

  21. Neurothesiometer [ Time Frame: Baseline, 3 months, 12 months, and 24 months ]
  22. NIH Toolbox Cognitive Battery [ Time Frame: Baseline and at 24 months ]
  23. Rey Auditory Verbal Learning Test [ Time Frame: Baseline and at 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617185


Contacts
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Contact: Ericka Chant, MPH 734-936-8770 echant@med.umich.edu
Contact: Emily Villegas-Umana, BSN, RN 734-936-8780 ligonemi@med.umich.edu

Locations
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United States, Michigan
University Of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Ericka Chant, MPH    734-936-8778    echant@med.umich   
Contact: Emily Villegas-Umana, BSN    734-936-8780    ligonemi@med.umich.edu   
Principal Investigator: Brian C Callaghan, MD, MS         
Sponsors and Collaborators
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Brian C Callaghan, MD, MS University of Michigan, Department of Neurology

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Responsible Party: Brian Callaghan, Fovette E Dush Early Career Professor and Assistant Professor of Neurology, University of Michigan
ClinicalTrials.gov Identifier: NCT03617185     History of Changes
Other Study ID Numbers: HUM00143541
1R01DK115687-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brian Callaghan, University of Michigan:
Metabolic syndrome
Exercise
Additional relevant MeSH terms:
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Polyneuropathies
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases