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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

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Intraepidermal Nerve Fiber Density (IENFD) at the proximal thigh
Secondary outcome measures
24-2 Frequency Doubling Technology (FDT)
8 Foot Get Up and Go Test
Berg Balance Scale
+18 more

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.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,817 Previous Clinical Trials
6,387,222 Total Patients Enrolled
33 Trials studying Obesity
9,825 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,381 Previous Clinical Trials
4,314,962 Total Patients Enrolled
453 Trials studying Obesity
588,825 Patients Enrolled for Obesity
Brian C Callaghan, MD, MSPrincipal InvestigatorUniversity of Michigan, Department of Neurology
1 Previous Clinical Trials
177 Total Patients Enrolled
1 Trials studying Obesity
177 Patients Enrolled for Obesity

Media Library

Bariatric surgery (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03617185 — N/A
Obesity Research Study Groups: Bariatric Surgery/HIIT, Bariatric Surgery/Routine Exercise, No Bariatric Surgery/HIIT, No Bariatric Surgery/Routine Exercise
Obesity Clinical Trial 2023: Bariatric surgery Highlights & Side Effects. Trial Name: NCT03617185 — N/A
Bariatric surgery (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03617185 — N/A
Obesity Patient Testimony for trial: Trial Name: NCT03617185 — N/A
~0 spots leftby Jul 2024