Lifestyle Modification for Diabetic Neuropathy

(IMABIN Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Pregnancy, Prisoners, Severe conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a personalized program of diet, physical activity, and balance exercises (lifestyle modification) can improve nerve function and balance in people with early-stage type 2 diabetes or prediabetes. The researchers aim to determine if these lifestyle changes can reduce symptoms like dizziness or cold feet and lower the risk of falls. Participants will follow a tailored plan of aerobic exercises and balance training to assess improvements in quality of life. This trial is suitable for individuals with impaired glucose regulation (early-stage diabetes or prediabetes) who experience symptoms such as dizziness, dry mouth, or balance issues.

As an unphased trial, this study provides an opportunity to contribute to understanding how lifestyle changes can improve health outcomes.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. However, if you are on diabetes medication, you need to have been stable on it for at least 3 months before joining the study.

What prior data suggests that this lifestyle modification is safe for improving autonomic function and balance in individuals with impaired glucose regulation?

Research has shown that lifestyle changes, such as diet and exercise, are generally safe and low-risk for individuals with diabetic nerve pain. Studies have found that these changes offer many benefits with minimal risk. Participants in these programs often experience improved health without serious side effects.

Exercise, particularly activities like walking or cycling, is associated with better nerve health and fewer complications. This type of exercise is safe and can help slow nerve damage.

Additionally, programs that incorporate exercise and dietary changes have proven helpful for people with diabetes, improving symptoms and overall health. These programs are tailored to each individual, making them both safe and effective for managing diabetic nerve pain.

In summary, lifestyle changes are well-tolerated and provide a safe way to potentially enhance health for those with diabetic nerve pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for diabetic neuropathy focus on managing symptoms with medications like pain relievers or antidepressants. However, researchers are excited about this trial because it emphasizes a holistic approach through lifestyle modification. The Diet, Physical Activity, and Balance Enhancement Program (DPAEP) is unique because it provides a personalized plan that combines structured weight loss, weight maintenance, and aerobic exercise tailored to individual needs. This approach not only targets weight and fitness but also aims to improve autonomic function, potentially offering benefits beyond what current medication can achieve. By focusing on meaningful, personalized activities and consistent support, this treatment could lead to improved overall health and quality of life for patients.

What evidence suggests that lifestyle modification might be an effective treatment for diabetic neuropathy?

Research has shown that lifestyle changes, such as exercising and eating a healthy diet, can aid individuals with diabetic nerve damage. In this trial, participants in the Diet, Physical Activity, and Balance Enhancement Program (DPAEP) group will follow a structured weight loss and aerobic exercise program. One study found that these changes can slow the progression of nerve damage in people with diabetes. Another study demonstrated that aerobic exercise, such as walking or cycling, can enhance nerve function. These lifestyle changes can also improve balance, which is crucial for preventing falls. Overall, these changes offer a promising approach to managing symptoms and improving the quality of life for those with early diabetes or blood sugar control issues. ^{1 2 3 6 7}

Who Is on the Research Team?

James W Russell, MD

Principal Investigator

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had issues with my blood sugar levels recently.

Women of childbearing potential must be using an acceptable method of contraception

My nerve pain is likely due to blood sugar issues.

Exclusion Criteria

I have nerve pain or weakness not caused by diabetes.

I do not have any severe illnesses that would stop me from completing the study.

My severe nerve damage affects my body's automatic functions and may limit my study participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Participants undergo baseline testing before randomization into study groups

1-2 weeks

Treatment

Participants in the DPAEP group undergo a structured weight loss and maintenance program, along with aerobic exercise for 12 months. The SC group receives general diet and physical activity information.

12 months

Regular face-to-face and telephone meetings

Follow-up

Participants are monitored for changes in autonomic function and balance control after the intervention

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• lifestyle modification

Trial Overview 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.

How Is the Trial Designed?

Group I: Diet, Physical Activity and Balance Enhancement Program (DPAE Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

An 8-week study involving 24 adults with diabetes and peripheral neuropathy showed that both exercise and education interventions significantly improved neuropathic signs and symptoms, as measured by the Michigan Neuropathy Screening Instrument and vibratory perception threshold.

While both interventions were effective, exercise appeared to have a slight edge in improving clinical signs and symptoms of neuropathy, suggesting that physical activity may be particularly beneficial in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Structured Exercise Compared with Education on Neuropathic Signs and Symptoms in People at Risk of Neuropathic Diabetic Foot Ulcers: A Randomized Clinical Trial. Perrin, BM., Southon, J., McCaig, J., et al.[2022]

Diabetic neuropathy significantly impacts patients' quality of life and is linked to serious complications like foot ulcers and increased mortality, highlighting the need for effective drug treatments.

Randomized clinical trials (RCTs) evaluating treatments for diabetic neuropathy have historically been of poor quality, emphasizing the importance of well-designed studies that consider factors like neuropathy stage, outcome measures, and long-term effects to ensure meaningful results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trials for drugs against diabetic neuropathy: can we combine scientific needs with clinical practicalities? Ziegler, D., Luft, D.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6697618/

Physical Activity and Dietary Interventions in Diabetic ... Physical activity and dietary interventions in patients with diabetes and diabetic neuropathy have multiple beneficial effects and are generally low risk.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5423967/

Effects of a long-term lifestyle modification programme on ... The aim of this study was to evaluate the effects on diabetic peripheral neuropathy (DPN) of a long-term intensive lifestyle intervention (ILI) programme

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04813146

Role of Synchronized Lifestyle Modification Program on ... In life style modification, variety of exercises are recommended that help to slow the progression of peripheral neuropathy.These include; aerobic training ...

4. nature.com nature.com/articles/s41392-025-02175-1

Diabetic neuropathy: cutting-edge research and future ... Collaborative care models enhance lifestyle interventions by focusing on diet, exercise, and foot care, essential for preventing complications ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1610955/full

Effectiveness of exercise on musculoskeletal function and ... Conclusion: The available evidence suggests that exercise training is an effective method for improving peripheral neuropathy. Systematic review ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6125024/

Lifestyle and the Prevention of Type 2 Diabetes: A Status ... For instance, ≥2.5 h/wk of moderate-intensity brisk walking is associated with a diabetes risk reduction of 27%, independent of BMI. Furthermore, moderate- to ...

7. link.springer.com link.springer.com/article/10.1007/s00125-017-4253-z

Effects of a long-term lifestyle modification programme on ... The aim of this study was to evaluate the effects on diabetic peripheral neuropathy (DPN) of a long-term intensive lifestyle intervention (ILI) programme