Reversing Diabetic Peripheral Neuropathy Through Exercise

NCT03686423 | Completed Results

• 1 other identifier: 18-00527
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Neuropathy; Diabetes

Keywords

Exercise

Outcome Measures

Primary Outcomes (24)

• Body Mass Index (BMI)

  The BMI calculation divides an adult's weight in kilograms by their height in meters squared.

  Baseline

• Change From Baseline in Body Mass Index (BMI)

  The BMI calculation divides an adult's weight in kilograms by their height in meters squared.

  Week 10

• Glycosylated Hemoglobin (HbA1c)

  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.

  Baseline

• Glycosylated Hemoglobin (HbA1c)

  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.

  Week 10

• C-Reactive Protein Levels

  Measured via patient blood samples.

  Baseline

• C-Reactive Protein Levels

  Measured via patient blood samples.

  Week 10

• Michigan Neuropathy Screening Instrument (MNSI) Symptom Questionnaire

  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.

  Baseline

• Michigan Neuropathy Screening Instrument (MNSI) Symptom Questionnaire

  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.

  Week 10

• MNSI Physical Exam Score

  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.

  Baseline

• MNSI Physical Exam Score

  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.

  Week 10

• Calf Muscle Performance

  Performance will be quantified as peak ankle plantarflexion torque at 60 degrees/sec.

  Baseline

• Calf Muscle Performance

  Performance will be quantified as peak ankle plantarflexion torque at 60 degrees/sec.

  Week 10

• Physical Performance Test (PP) Score

  9-item assessment of Physical Performance. The total score ranges from 0 to 36; higher scores indicate greater levels of physical performance.

  Baseline

• Physical Performance Test (PP) Score

  9-item assessment of Physical Performance. The total score ranges from 0 to 36; higher scores indicate greater levels of physical performance.

  Week 10

• PCr Resynthesis Rate in the Gastrocnemius Muscle Groups

  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.

  Baseline

• PCr Resynthesis Rate in the Gastrocnemius Muscle Groups

  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.

  Week 10

• Intramuscular Adipose Tissue (IMAT) Levels in the Gastrocnemius Muscle Groups

  Measured using IDEAL-MRI. IMAT levels are quantified as a percentage of total tissue in the gastrocnemius muscle groups of both calf muscles combined.

  Baseline

• Intramuscular Adipose Tissue (IMAT) Levels in the Gastrocnemius Muscle Groups

  Measured using IDEAL-MRI. IMAT levels are quantified as a percentage of total tissue in the gastrocnemius muscle groups of both calf muscles combined.

  Week 10

• IMAT Levels in the Soleus Muscle Groups

  Measured using IDEAL-MRI. IMAT levels are quantified as a percentage of total tissue in the soleus muscle groups of both calf muscles combined.

  Baseline

• IMAT Levels in the Soleus Muscle Groups

  Measured using IDEAL-MRI. IMAT levels are quantified as a percentage of total tissue in the soleus muscle groups of both calf muscles combined.

  Week 10

• Fractional Anisotropy (FA) in the Tibial Nerve

  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).

  Baseline

• Fractional Anisotropy (FA) in the Tibial Nerve

  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).

  Week 10

• Apparent Diffusion Coefficient (ADC) in the Tibial Nerve

  ADC is a measure of the magnitude of diffusion (of water molecules) within tissue. Measured using DTI.

  Baseline

• Apparent Diffusion Coefficient (ADC) in the Tibial Nerve

  ADC is a measure of the magnitude of diffusion (of water molecules) within tissue. Measured using DTI.

  Week 10

Study Arms (1)

Patients with Type 2 Diabetes and Clinical Symptoms of DPN

EXPERIMENTAL

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.

Procedure: Exercise Program

Interventions

Exercise Program PROCEDURE

The exercise program will combine moderate intensity aerobic exercise with lower-extremity specific resistance training. A moderate level of intensity will be calculated based on results from a maximal graded exercise test (VO2R) conducted prior to the intervention.

Patients with Type 2 Diabetes and Clinical Symptoms of DPN

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Diabetes Mellitus; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Ryan Brown, PhD
• Organization: NYU Langone Health

Ryan.Brown@nyulangone.org

2122633396

Study Officials

• Ryan Brown, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 27, 2018
• Study Start: November 28, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 17, 2023
• Results First Posted: May 17, 2023

Record last verified: 2023-04

Locations

US (1)