← Back to Search

Lifestyle Modification for Diabetic Neuropathy (IMABIN Trial)

N/A
Waitlist Available
Led By James W Russell, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with increased risk for diabetes with a HBA1C greater than or equal to 5.7%, or diabetes with a HBA1C greater than or equal to 6.5%, or abnormal fasting venous glucose, or abnormal venous glucose values following a 75 gram oral glucose load
Diabetic subjects on medication should be stable on medication for at least 3 months prior to entering the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights

IMABIN Trial Summary

This trial will test an aerobic exercise and balance intervention in participants with impaired glucose regulation (IGR). The investigators will examine if this intervention can improve autonomic function and balance control when compared to patients who receive standard care.

Who is the study for?
This trial is for adults aged 30-80 with diabetic neuropathy due to impaired glucose regulation, including prediabetes and early diabetes. Participants must not be pregnant or imprisoned, have stable medical conditions, and agree to use contraception if applicable. They should not have severe autonomic neuropathy that limits participation in the study.Check my eligibility
What is being tested?
The trial tests a Diet, Physical Activity, and Balance Enhancement Program (DPAEP) aimed at improving autonomic function and balance in people with impaired glucose regulation. It compares this intervention's effectiveness against standard care in preventing or reversing neuropathy.See study design
What are the potential side effects?
While specific side effects are not listed for lifestyle modifications like diet and exercise programs, potential risks may include muscle soreness, fatigue, falls during balance training exercises, or exacerbation of existing health issues.

IMABIN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am at risk for diabetes or have diabetes based on my HBA1C levels or glucose tests.
Select...
My diabetes medication has been stable for at least 3 months.
Select...
My nerve pain is likely due to blood sugar issues.
Select...
I have had issues with my blood sugar levels recently.
Select...
I am between 30 and 80 years old.
Select...
I agree to switch from coumadin for a skin biopsy.

IMABIN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 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
Autonomic Function: heart rate variability
Secondary outcome measures
balance
Other outcome measures
Sweat gland nerve fiber density

IMABIN Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Diet, Physical Activity and Balance Enhancement Program (DPAEExperimental Treatment1 Intervention
Subjects in the DPAEP group will undergo a structured weight loss for approximately 6 months, followed by approximately 6 months of weight maintenance, as well as 12 months of aerobic exercise. This intervention stresses a personalized program emphasizing activities that are meaningful to and are tailored to individual participants; provides consistent contact between the participants and research staff; and allows monitoring of activity levels using questionnaires, actigraphy, monitoring of heart rate, direct and telephone contact. Participants dietary and physical activity goals as assessed by the dietician and trainer will be discussed at face-to face meetings to re-establish these goals. These programs will be tailored to meet the realistic goals of the individual participant. The program stresses aerobic exercise, rather than other types of exercise interventions, as aerobic exercise appears to correlate best with improved autonomic function.
Group II: Standard Care (SC)Active Control1 Intervention
The SC group will be assigned an interventionist assessor. This assessor will meet with the subjects during their orientation meeting and will be provided guidelines and a weight loss and physical activity target to achieve by the end of the program at their orientation meeting. Participants will contacted approximately weekly during the approximate 12 month period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
lifestyle modification
2019
Completed Phase 4
~1040

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,543 Total Patients Enrolled
22 Trials studying Diabetes
13,550 Patients Enrolled for Diabetes
James W Russell, MDPrincipal InvestigatorBaltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
2 Previous Clinical Trials
126 Total Patients Enrolled
1 Trials studying Diabetes
72 Patients Enrolled for Diabetes

Media Library

lifestyle modification Clinical Trial Eligibility Overview. Trial Name: NCT01864460 — N/A
Diabetes Research Study Groups: Diet, Physical Activity and Balance Enhancement Program (DPAE, Standard Care (SC)
Diabetes Clinical Trial 2023: lifestyle modification Highlights & Side Effects. Trial Name: NCT01864460 — N/A
lifestyle modification 2023 Treatment Timeline for Medical Study. Trial Name: NCT01864460 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can I contribute to this research initiative?

"To take part in this trial, potential participants must have impaired glucose tolerance and be between the ages of 30 and 80. This medical study is accepting 60 applicants in total."

Answered by AI

Is enrollment for this experiment still open?

"According to clinicaltrials.gov, this experiment is no longer enrolling patients; the study was initially posted on November 14th 2013 and last edited March 21st 2022. However, there are 498 other medical studies currently recruiting volunteers for participation."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
Maryland
What site did they apply to?
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Improving Autonomic Function and Balance in Diabetic Neuropathy
2013. "Improving Autonomic Function and Balance in Diabetic Neuropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01864460.
All > Prediabetes > Diabetic Neuropathy
~5 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top