Reversing Diabetic Peripheral Neuropathy Through Exercise

Not Applicable

Completed

• Conditions: Peripheral Neuropathy; Diabetes
• Interventions: Procedure: Exercise Program

• Registration Number: NCT03686423
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2018-09-25
• Study First Posted: 2018-09-27
• Study Start: 2018-11-28
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-04
• Results First Submitted: 2023-04-03
• Results First Submitted QC: 2023-04-24
• Last Update Submitted: 2023-04-24
• Results First Posted: 2023-05-17
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Type 2 Diabetes and Clinical Symptoms of DPN	Exercise Program	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.

Primary Outcome Measures

Name	Time	Method
C-Reactive Protein Levels	Week 10	Measured via patient blood samples.
Glycosylated Hemoglobin (HbA1c)	Week 10	The glycosylated hemoglobin test shows what a person's average blood glucose level was for the 2 to 3 months before the test. Measured via patient blood samples.
Change From Baseline in Body Mass Index (BMI)	Week 10	The BMI calculation divides an adult's weight in kilograms by their height in meters squared.
MNSI Physical Exam Score	Week 10	Completed by physician. Assessment of abnormalities in the appearance of the feet, vibration sense, reflexes, and monofilament sensation. The total score ranges from 0-10; lower scores indicate greater physical health; a decrease in scores indicates physical health increased during the observational period.
Intramuscular Adipose Tissue (IMAT) Levels in the Gastrocnemius Muscle Groups	Week 10	Measured using IDEAL-MRI. IMAT levels are quantified as a percentage of total tissue in the gastrocnemius muscle groups of both calf muscles combined.
IMAT Levels in the Soleus Muscle Groups	Week 10	Measured using IDEAL-MRI. IMAT levels are quantified as a percentage of total tissue in the soleus muscle groups of both calf muscles combined.
Fractional Anisotropy (FA) in the Tibial Nerve	Week 10	FA is a scalar value between zero and one that describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions. Measured using Diffusion Tensor Imaging (DTI).
Apparent Diffusion Coefficient (ADC) in the Tibial Nerve	Week 10	ADC is a measure of the magnitude of diffusion (of water molecules) within tissue. Measured using DTI.
Body Mass Index (BMI)	Baseline	The BMI calculation divides an adult's weight in kilograms by their height in meters squared.
Michigan Neuropathy Screening Instrument (MNSI) Symptom Questionnaire	Week 10	15-question assessment of symptoms. Responses of "yes" to items 1-3, 5-6, 8-9, 11-12, 14-15 are each counted as one point. A "no" response on items 7 and 13 counts as 1 point. Item 4 is a measure of impaired circulation and item 10 is a measure of general asthenia; neither are included in scoring. The total score ranges from 0-13; lower scores indicate less prevalent symptoms; a decrease in scores indicates symptoms decreased during the observational period.
Calf Muscle Performance	Week 10	Performance will be quantified as peak ankle plantarflexion torque at 60 degrees/sec.
PCr Resynthesis Rate in the Gastrocnemius Muscle Groups	Week 10	Measured using multinuclear-MRI following a 90-second plantar flexion exercise during which resistance is applied at approximately 40% of the individual's maximum voluntary contraction. The value reported in the data table represents the average flexion across both calf muscles.
Physical Performance Test (PP) Score	Week 10	9-item assessment of Physical Performance. The total score ranges from 0 to 36; higher scores indicate greater levels of physical performance.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States