Back to resultsReversing Diabetic Peripheral Neuropathy Through Exercise
Primary Purpose
Peripheral Neuropathy, Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Program
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Neuropathy focused on measuring Exercise
Eligibility Criteria
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with Type 2 Diabetes and Clinical Symptoms of DPN
Arm 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.
Outcomes
Primary Outcome Measures
Body Mass Index (BMI)
The BMI calculation divides an adult's weight in kilograms by their height in meters squared.
Change From Baseline in Body Mass Index (BMI)
The BMI calculation divides an adult's weight in kilograms by their height in meters squared.
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.
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.
C-Reactive Protein Levels
Measured via patient blood samples.
C-Reactive Protein Levels
Measured via patient blood samples.
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.
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.
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.
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.
Calf Muscle Performance
Performance will be quantified as peak ankle plantarflexion torque at 60 degrees/sec.
Calf Muscle Performance
Performance will be quantified as peak ankle plantarflexion torque at 60 degrees/sec.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03686423
First Posted
September 25, 2018
Last Updated
April 24, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT03686423
Brief Title
Reversing Diabetic Peripheral Neuropathy Through Exercise
Official Title
Reversing Diabetic Peripheral Neuropathy Through Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 28, 2018 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy, Diabetes
Keywords
Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with Type 2 Diabetes and Clinical Symptoms of DPN
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Exercise Program
Intervention Description
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 Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
The BMI calculation divides an adult's weight in kilograms by their height in meters squared.
Time Frame
Baseline
Title
Change From Baseline in Body Mass Index (BMI)
Description
The BMI calculation divides an adult's weight in kilograms by their height in meters squared.
Time Frame
Week 10
Title
Glycosylated Hemoglobin (HbA1c)
Description
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.
Time Frame
Baseline
Title
Glycosylated Hemoglobin (HbA1c)
Description
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.
Time Frame
Week 10
Title
C-Reactive Protein Levels
Description
Measured via patient blood samples.
Time Frame
Baseline
Title
C-Reactive Protein Levels
Description
Measured via patient blood samples.
Time Frame
Week 10
Title
Michigan Neuropathy Screening Instrument (MNSI) Symptom Questionnaire
Description
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.
Time Frame
Baseline
Title
Michigan Neuropathy Screening Instrument (MNSI) Symptom Questionnaire
Description
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.
Time Frame
Week 10
Title
MNSI Physical Exam Score
Description
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.
Time Frame
Baseline
Title
MNSI Physical Exam Score
Description
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.
Time Frame
Week 10
Title
Calf Muscle Performance
Description
Performance will be quantified as peak ankle plantarflexion torque at 60 degrees/sec.
Time Frame
Baseline
Title
Calf Muscle Performance
Description
Performance will be quantified as peak ankle plantarflexion torque at 60 degrees/sec.
Time Frame
Week 10
Title
Physical Performance Test (PP) Score
Description
9-item assessment of Physical Performance. The total score ranges from 0 to 36; higher scores indicate greater levels of physical performance.
Time Frame
Baseline
Title
Physical Performance Test (PP) Score
Description
9-item assessment of Physical Performance. The total score ranges from 0 to 36; higher scores indicate greater levels of physical performance.
Time Frame
Week 10
Title
PCr Resynthesis Rate in the Gastrocnemius Muscle Groups
Description
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.
Time Frame
Baseline
Title
PCr Resynthesis Rate in the Gastrocnemius Muscle Groups
Description
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.
Time Frame
Week 10
Title
Intramuscular Adipose Tissue (IMAT) Levels in the Gastrocnemius Muscle Groups
Description
Measured using IDEAL-MRI. IMAT levels are quantified as a percentage of total tissue in the gastrocnemius muscle groups of both calf muscles combined.
Time Frame
Baseline
Title
Intramuscular Adipose Tissue (IMAT) Levels in the Gastrocnemius Muscle Groups
Description
Measured using IDEAL-MRI. IMAT levels are quantified as a percentage of total tissue in the gastrocnemius muscle groups of both calf muscles combined.
Time Frame
Week 10
Title
IMAT Levels in the Soleus Muscle Groups
Description
Measured using IDEAL-MRI. IMAT levels are quantified as a percentage of total tissue in the soleus muscle groups of both calf muscles combined.
Time Frame
Baseline
Title
IMAT Levels in the Soleus Muscle Groups
Description
Measured using IDEAL-MRI. IMAT levels are quantified as a percentage of total tissue in the soleus muscle groups of both calf muscles combined.
Time Frame
Week 10
Title
Fractional Anisotropy (FA) in the Tibial Nerve
Description
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).
Time Frame
Baseline
Title
Fractional Anisotropy (FA) in the Tibial Nerve
Description
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).
Time Frame
Week 10
Title
Apparent Diffusion Coefficient (ADC) in the Tibial Nerve
Description
ADC is a measure of the magnitude of diffusion (of water molecules) within tissue. Measured using DTI.
Time Frame
Baseline
Title
Apparent Diffusion Coefficient (ADC) in the Tibial Nerve
Description
ADC is a measure of the magnitude of diffusion (of water molecules) within tissue. Measured using DTI.
Time Frame
Week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Brown, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
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Reversing Diabetic Peripheral Neuropathy Through Exercise
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