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Completed

NCT Number: NCT03686423

Reversing Diabetic Peripheral Neuropathy Through Exercise

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.

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Key information

Conditions

Peripheral Neuropathy Behavior Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Body Mass Index (BMI)

    Time frame: Baseline

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

  2. Change From Baseline in Body Mass Index (BMI)

    Time frame: Week 10

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

  3. Glycosylated Hemoglobin (HbA1c)

    Time frame: Baseline

    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.

  4. Glycosylated Hemoglobin (HbA1c)

    Time frame: 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.

  5. C-Reactive Protein Levels

    Time frame: Baseline

    Measured via patient blood samples.

  6. C-Reactive Protein Levels

    Time frame: Week 10

    Measured via patient blood samples.

  7. Michigan Neuropathy Screening Instrument (MNSI) Symptom Questionnaire

    Time frame: Baseline

    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.

  8. Michigan Neuropathy Screening Instrument (MNSI) Symptom Questionnaire

    Time frame: 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.

  9. MNSI Physical Exam Score

    Time frame: Baseline

    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.

  10. MNSI Physical Exam Score

    Time frame: 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.

  11. Calf Muscle Performance

    Time frame: Baseline

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

  12. Calf Muscle Performance

    Time frame: Week 10

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

  13. Physical Performance Test (PP) Score

    Time frame: Baseline

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

  14. Physical Performance Test (PP) Score

    Time frame: Week 10

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

  15. PCr Resynthesis Rate in the Gastrocnemius Muscle Groups

    Time frame: Baseline

    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.

  16. PCr Resynthesis Rate in the Gastrocnemius Muscle Groups

    Time frame: 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.

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

    Time frame: Baseline

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

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

    Time frame: 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.

  19. IMAT Levels in the Soleus Muscle Groups

    Time frame: Baseline

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

  20. IMAT Levels in the Soleus Muscle Groups

    Time frame: 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.

  21. Fractional Anisotropy (FA) in the Tibial Nerve

    Time frame: Baseline

    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).

  22. Fractional Anisotropy (FA) in the Tibial Nerve

    Time frame: 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).

  23. Apparent Diffusion Coefficient (ADC) in the Tibial Nerve

    Time frame: Baseline

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

  24. Apparent Diffusion Coefficient (ADC) in the Tibial Nerve

    Time frame: Week 10

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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Sep 27, 2018
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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