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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 12 months, 24 months
Awards & highlights
Study 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.
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
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 moreTrial 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
1,797 Previous Clinical Trials
6,377,918 Total Patients Enrolled
33 Trials studying Obesity
9,825 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,315,355 Total Patients Enrolled
446 Trials studying Obesity
588,798 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am visiting a clinic for weight loss surgery.I cannot undergo surgery due to medical or mental health reasons.My BMI is over 35 with a health condition or over 40 without any.I am currently being treated for cancer, not including basal or squamous skin cancer.I need a device to help me walk.I am taking blood thinners that could complicate a skin biopsy.I am willing and able to follow the study's procedures and sign the consent form.I am open to being randomly assigned to high-intensity interval training or standard exercise advice.I have a history of nerve damage in my hands and feet not caused by diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Bariatric Surgery/HIIT
- Group 2: Bariatric Surgery/Routine Exercise
- Group 3: No Bariatric Surgery/HIIT
- Group 4: No Bariatric Surgery/Routine Exercise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT03617185 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any availability for participants in this research?
"Per clinicaltrials.gov, this particular medical trial is currently not seeking volunteers. It was originally posted on July 12th 2018 and last updated November 2nd 2022; however, 1142 other trials are actively recruiting at present."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
Illinois
Ohio
How old are they?
18 - 65
What site did they apply to?
University Of Michigan
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I've tried to lose weight multiple times and always gain it back. I want to change my lifestyle. I want to be an active person and am hoping this trial will help me establish routines and a body of knowledge that will help me achieve these goals.
PatientReceived 1 prior treatment
I have tried weight loss prescription drugs, exercise programs, as well as lifestyle change programs and have not seen any positive results and my weight continues to go up. I had another trial surgery in 2008 and was able to drop a little over 100lbs and keep it off until these last 2 years in which time I have gained most of it back without explaination.
PatientReceived 1 prior treatment
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