Effect of Exercise and Surgical Weight Loss on Polyneuropathy

Obesity Clinical Trial

Official title:

The Effect of High Intensity Interval Training and Surgical Weight Loss on Distal Symmetric Polyneuropathy Outcomes

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
• 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
• 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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity
• Polyneuropathies
• Weight Loss

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