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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03617185
Other study ID # HUM00143541
Secondary ID 1R01DK115687-01A
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 12, 2018
Est. completion date July 30, 2024

Study information

Verified date February 2024
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 140
Est. completion date July 30, 2024
Est. primary completion date July 30, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design


Intervention

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.
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

Locations

Country Name City State
United States University Of Michigan Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline, 3 months, 12 months and 24 months
Secondary 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. Baseline, 3 months, 12 months and 24 months
Secondary Corneal Confocal Microscopy (CCM) Baseline, 3 month, 12 months and 24 months
Secondary 24-2 Frequency Doubling Technology (FDT) Baseline, 3 month, 12 months and 24 months
Secondary Retinal Fundus Photography Baseline, 3 month, 12 months and 24 months
Secondary Nerve Conduction Study (NCS) Sural, peroneal, and tibial nerves. Baseline and 24 months
Secondary Cardiac Autonomic Neuropathy Testing Deep breathing-E:I ratio Baseline and 24 months
Secondary Cardiac Autonomic Neuropathy Testing Postural change-30:15 ratio Baseline and 24 months
Secondary Cardiac Autonomic Neuropathy Testing Valsalva- Valsalva ratio Baseline and 24 months
Secondary 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. 24 months
Secondary Michigan Neuropathy Screening Instrument (MNSI) Baseline, 3 month, 12 months and 24 months
Secondary Utah Early Neuropathy Score Scale 0-48, higher is more severe polyneuropathy Baseline, 3 month, 12 months and 24 months
Secondary Modified Toronto Neuropathy Score (mTNS) Range 0-33, higher is more severe polyneuropathy Baseline, 3 month, 12 months and 24 months
Secondary Survey of Autonomic Symptoms (SAS) Baseline, 3 month, 12 months and 24 months
Secondary Diabetic Neuropathy Score (DNS) Range 0-4, >/=1 indicates polyneuropathy Baseline, 3 month, 12 months and 24 months
Secondary Short Form McGill Pain Questionnaire Baseline, 3 months, 12 months, 24 months
Secondary Numerical Rating Scale for pain Range 0-10, higher score indicates more pain Baseline, 3 months, 12 months, 24 months
Secondary Neuropathy Quality of Life (NeuroQOL) Baseline, 3 months, 12 months, and 24 months
Secondary Berg Balance Scale Range 0-56, higher score indicates less likely to fall Baseline, 3 months, 12 months, and 24 months
Secondary 8 Foot Get Up and Go Test Baseline, 3 months, 12 months, and 24 months
Secondary Modified Falls Efficacy Scale Range 0-140, higher score indicates less likely to fall Baseline, 3 months, 12 months, and 24 months
Secondary Neurothesiometer Baseline, 3 months, 12 months, and 24 months
Secondary NIH Toolbox Cognitive Battery Baseline and at 24 months
Secondary Rey Auditory Verbal Learning Test Baseline and at 24 months
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