Reversing Diabetic Peripheral Neuropathy Through Exercise

Diabetes Clinical Trial

Official title:

Reversing Diabetic Peripheral Neuropathy Through Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03686423
• Other study ID #: 18-00527
• Status: Completed
• Phase: N/A
• Start date: November 28, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Procedure:
• Exercise Program
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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index (BMI)	The BMI calculation divides an adult's weight in kilograms by their height in meters squared.	Baseline
Primary	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
Primary	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
Primary	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
Primary	C-Reactive Protein Levels	Measured via patient blood samples.	Baseline
Primary	C-Reactive Protein Levels	Measured via patient blood samples.	Week 10
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Calf Muscle Performance	Performance will be quantified as peak ankle plantarflexion torque at 60 degrees/sec.	Baseline
Primary	Calf Muscle Performance	Performance will be quantified as peak ankle plantarflexion torque at 60 degrees/sec.	Week 10
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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