Reversing Diabetic Peripheral Neuropathy Through Exercise

NYU Langone Health

Status: Completed

Conditions: Peripheral Neuropathy; Diabetes

Treatments: Procedure: Exercise Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03686423

18-00527

Details and patient eligibility

About

This project proposes a longitudinal design that uses multinuclear-MRI to evaluate the mechanistic effects of exercise on skeletal muscle function and peripheral nerve integrity in patients with diabetic peripheral neuropathy (DPN), and to determine whether exercise can reverse DPN symptoms. The investigators will prescribe a 10-week exercise program to 40 DPN patients. The investigators will acquire multinuclear-MRI data before and after the intervention that can provide mechanistic insight into the adaptations in lower leg muscle function and peripheral nerve integrity of patients with DPN, and their role in improving DPN symptoms following physical exercise intervention.

Enrollment: 44 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be between the ages of 40 and 70
• Clinical diagnosis of Type 2 diabetes
• Clinical diagnosis of DPN
• Have a BMI less than 40 kg/m2 (due to magnet bore restrictions)
• Able to walk unassisted

Exclusion criteria

• Serious cardiac pathology or musculoskeletal problems that would limit exercise ability
• MNSI score < 1
• Current open wound or history of plantar ulcer for the last 3 months
• Partial foot amputations
• Inability to ambulate without assistive device
• Stroke or other central nervous system pathology
• Stage 2 hypertension (resting blood pressure >160 systolic or >100 diastolic)
• Contraindications to 3T whole body MRI scanners (e.g., pacemaker, cerebral aneurysm clip, cochlear implant, presence of shrapnel in strategic locations, metal in the eye, claustrophobia, or other problems).
• Subjects with alcoholism, chronic drug use, chronic gastrointestinal disease, or renal or hepatic impairment
• Pregnant women and children

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Patients with Type 2 Diabetes and Clinical Symptoms of DPN

Experimental group

Description:

Patients will be individually prescribed to a 10-week exercise program with both aerobic and resistance components. Prior to beginning the intervention, patients will participate in a maximal graded exercise test (VO2R) using a cycle ergometer with a metabolic cart and integrated ECG.

Treatment:

Procedure: Exercise Program