Peripheral NeuropathyNCT03686423
Reversing Diabetic Peripheral Neuropathy Through Exercise
A study testing Exercise Program in people with Peripheral Neuropathy and Diabetes, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Peripheral Neuropathy, Diabetes
- What is being tested?
- Exercise Program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2018to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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
- Being tested
- Exercise Program
- Keywords
- Exercise
- Medical subject headings
- Peripheral Nervous System Diseases, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
The BMI calculation divides an adult's weight in kilograms by their height in meters squared.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 10
C-Reactive Protein Levels
Measured via patient blood samples.
Measured: Baseline
C-Reactive Protein Levels
Measured via patient blood samples.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 10
Calf Muscle Performance
Performance will be quantified as peak ankle plantarflexion torque at 60 degrees/sec.
Measured: Baseline
Calf Muscle Performance
Performance will be quantified as peak ankle plantarflexion torque at 60 degrees/sec.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start28 Nov 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Brown, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686423
- Sponsor's protocol ID
- 18-00527
- Status last verified
- Apr 2023
- First submitted
- 25 Sep 2018
- Last updated
- 17 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversing Diabetic Peripheral Neuropathy Through Exercise
- ClinicalTrials.gov ID
- NCT03686423
- Acronym / sponsor ID
- 18-00527
- Conditions
- Peripheral Neuropathy, Diabetes
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 27 Sep 2018 (actual)
- Results
- Posted 17 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Type 2 Diabetes and Clinical Symptoms of DPN | Experimental | Procedure: Exercise ProgramPatients 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise ProgramThe 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. | Procedure or surgery | Patients with Type 2 Diabetes and Clinical Symptoms of DPN |
Primary outcome
Body Mass Index (BMI)
Time frame: Baseline
The BMI calculation divides an adult's weight in kilograms by their height in meters squared.
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.
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.
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.
C-Reactive Protein Levels
Time frame: Baseline
Measured via patient blood samples.
C-Reactive Protein Levels
Time frame: Week 10
Measured via patient blood samples.
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.
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.
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.
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.
Calf Muscle Performance
Time frame: Baseline
Performance will be quantified as peak ankle plantarflexion torque at 60 degrees/sec.
Calf Muscle Performance
Time frame: Week 10
Performance will be quantified as peak ankle plantarflexion torque at 60 degrees/sec.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Peripheral Neuropathy
Not yet recruiting
Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Effects of Perturbation-Based Versus Conventional Balance Training on Reactive Stepping Ability in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Brown, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program in people with Peripheral Neuropathy and Diabetes, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) (time frame: Baseline). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023; AzTrials last refreshed its copy on 31 Oct 2026.