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Procedure

Weight Loss Strategies for Polyneuropathy

N/A

Waitlist Available

Led By Brian C Callaghan, MD, MS

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Use of warfarin, heparin, or other anticoagulants, which would increase the risk of complications from skin biopsy

Undergoing therapy for malignant disease other than basal-cell or squamous-cell skin cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 12 months, 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers learn how effective exercise and weight loss surgery are in preventing nerve damage and other neurological problems.

Who is the study for?

This trial is for individuals with obesity, considering bariatric surgery, who have a BMI over 35 with a related health issue or over 40 without. They must be able to consent and follow medical procedures, willing to be randomly assigned to different exercise routines (HIIT or standard advice), and not currently smoking. Those with certain types of neuropathy, on blood thinners, failing an exercise stress test, in other drug trials recently, undergoing cancer therapy (except some skin cancers), unable to undergo surgery medically or psychiatrically, or needing walking aids cannot join.

What is being tested?

The study is looking at how two forms of exercise—High Intensity Interval Training (HIIT) and routine exercise counseling—affect the development of peripheral neuropathy in obese individuals planning bariatric surgery. Participants will be randomly placed into either the HIIT program or given routine exercise advice.

What are the potential side effects?

Potential side effects from participating could include typical risks associated with high-intensity workouts like muscle strains or injuries for those in the HIIT group. Bariatric surgery carries its own risks such as infection, bleeding, and complications from anesthesia.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking blood thinners that could complicate a skin biopsy.

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I am currently being treated for cancer, not including basal or squamous skin cancer.

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I cannot undergo surgery due to medical or mental health reasons.

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I need a device to help me walk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 12 months, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 12 months, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 12 months, 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Intraepidermal Nerve Fiber Density (IENFD) at the proximal thigh

Secondary study objectives

Berg Balance Scale

Cardiac Autonomic Neuropathy Testing

Change in Intraepidermal Nerve Fiber Density (IENFD) at distal leg.

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Active Control

Group I: Bariatric Surgery/HIITActive Control2 Interventions

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.

Group II: Bariatric Surgery/Routine ExerciseActive Control2 Interventions

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

Group III: No Bariatric Surgery/HIITActive Control1 Intervention

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.

Group IV: No Bariatric Surgery/Routine ExerciseActive Control1 Intervention

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

0 / 4Eligibility criteria met