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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Type 2 diabetes (DM2) affects nearly 20 million people in the United States while impaired glucose regulation (IGR), which includes impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and early diabetes affects a considerably larger but unknown population group. At the current time there is no effective therapy to completely prevent, or reverse neuropathy associated with IGR and this represents a considerable challenge in rehabilitation. There is a particularly strong incentive to prevent IGT and related complications from advancing to DM2. IGR is a growing problem among all older adults and its strong association with many functional limitations, particularly mobility limitations, is not always recognized, even though diabetes-related disability occurs in up to 2/3 of older adults with diabetes and is associated with dependency, poor quality of life, and increased acute and long-term care utilization. Autonomic dysfunction is a significant problem in subjects with IGT. The Preliminary Data shows that over 90% of subjects with IGT have an abnormal score on questionnaires about autonomic symptoms such as lightheadedness, dry mouth or dry eyes, pale or blue feet, feet that are colder than the rest of the body, decreased sweating in the feet or increased sweating in the hands, nausea or bloating after eating, persistent diarrhea or constipation, or leaking of urine. In addition, patients with IGR have impaired balance control. These factors can increase the risk of falls in affected subjects. A non-randomized and non-controlled study showed that a diet and exercise intervention in patients with diabetes led to an overall improvement in autonomic function. Furthermore, it was shown that standing balance can be improved with a balance intervention program. However, there are no published studies that assess the effect of an intense physical activity intervention on autonomic function in IGR related neuropathy. This study will test an aerobic exercise and balance intervention in participants with IGR. The investigators will examine if an individually tailored, carefully monitored, Diet, Physical Activity, and Balance Enhancement Program (DPAEP) can improve autonomic function and balance control when compared to patients who receive standard care. Improving balance control and autonomic function can decrease the risk of falls and have a significant effect on the health of participants. The research is also significant because it will test subjects either before they become diabetic, or at an early stage in their diabetes, thus enhancing the chance of reversing the autonomic neuropathy or balance impairment. Furthermore, the study is designed to test whether improvement in autonomic function and balance is associated with improvement in clinical outcomes, quality of life, and the metabolic state of participants. Thus, the proposed interventions are likely to have a real life impact on participants and their health.

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 data supports the effectiveness of the treatment lifestyle modification for diabetic neuropathy?

Research shows that lifestyle changes, like exercise and education, can help improve symptoms of diabetic neuropathy, such as pain and sensory loss. Studies found that both exercise and lifestyle education led to improvements in neuropathic signs and symptoms, making lifestyle changes a promising option for managing this condition. ^{1 2 3 4 5}

Is lifestyle modification safe for people with diabetic neuropathy?

Lifestyle modifications, including exercise and education, have been shown to improve symptoms of diabetic neuropathy without any reported safety concerns in the studies reviewed. ^{3 4 5 6 7}

How does lifestyle modification treatment differ from other treatments for diabetic neuropathy?

Lifestyle modification for diabetic neuropathy is unique because it focuses on non-drug approaches like exercise and dietary changes, which can improve symptoms by enhancing nerve function and overall health. Unlike standard treatments that may involve medication, this approach aims to manage the condition through healthy habits, potentially offering a safer and more holistic option. ^{2 3 4 5 8}

Research Team

James W Russell, MD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Molecular Aspects in the Potential of Vitamins and Supplements for Treating Diabetic Neuropathy. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Physical activity and dietary interventions in diabetic neuropathy: a systematic review. [2023]

3. Turkey pubmed.ncbi.nlm.nih.gov

Effect of lifestyle interventions on diabetic peripheral neuropathy in patients with type 2 diabetes, result of a randomized clinical trial. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Effects of a long-term lifestyle modification programme on peripheral neuropathy in overweight or obese adults with type 2 diabetes: the Look AHEAD study. [2022]

5. Switzerland 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Diabetic peripheral neuropathy in people with type 2 diabetes: too little too late. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Emerging Nonpharmacologic Interventions to Treat Diabetic Peripheral Neuropathy. [2023]