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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

Impaired glucose regulation at the time of screening or within three months of screening, including patients with IFG, IGT, and early or mild DM2

Must not have

Neuropathy due to factors other than impaired glucose regulation

Current severe medical conditions that are active on the day of screening that would affect the patient's ability to participate in or complete the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at risk for diabetes or have diabetes based on my HBA1C levels or glucose tests.

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I have had issues with my blood sugar levels recently.

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I am between 30 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have nerve pain or weakness not caused by diabetes.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Autonomic Function: heart rate variability

Secondary study objectives

balance

Other study objectives

Sweat gland nerve fiber density

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met