Trial Outcomes & Findings for Reversing Diabetic Peripheral Neuropathy Through Exercise (NCT NCT03686423)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

Baseline

Results posted on

2023-05-17

Participant Flow

Participant milestones

Participant milestones
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN 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. 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.
Overall Study STARTED	44
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN 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. 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.
Overall Study Withdrawal by Subject	9
Overall Study lost to follow up (study interrupted by COVID)	6

Baseline Characteristics

Reversing Diabetic Peripheral Neuropathy Through Exercise

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=29 Participants 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. 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.
Age, Continuous	61.4 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=29 Participants 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. 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.
Body Mass Index (BMI)	30.7 kg/m^2 Standard Deviation 4.2

PRIMARY outcome

Timeframe: Week 10

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

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=29 Participants 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. 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.
Change From Baseline in Body Mass Index (BMI)	30.2 kg/m^2 Standard Deviation 4.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=25 Participants 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. 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.
Glycosylated Hemoglobin (HbA1c)	7.4 percentage (%) of HbA1c Standard Deviation 1.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=25 Participants 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. 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.
Glycosylated Hemoglobin (HbA1c)	7.3 percentage (%) of HbA1c Standard Deviation 1.2

PRIMARY outcome

Timeframe: Baseline

Measured via patient blood samples.

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=25 Participants 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. 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.
C-Reactive Protein Levels	4.5 mg/L Standard Deviation 3.8

PRIMARY outcome

Timeframe: Week 10

Measured via patient blood samples.

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=25 Participants 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. 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.
C-Reactive Protein Levels	4.6 mg/L Standard Deviation 4.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=27 Participants 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. 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.
Michigan Neuropathy Screening Instrument (MNSI) Symptom Questionnaire	5.7 score on a scale Standard Deviation 1.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=27 Participants 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. 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.
Michigan Neuropathy Screening Instrument (MNSI) Symptom Questionnaire	4.8 score on a scale Standard Deviation 2.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=27 Participants 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. 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.
MNSI Physical Exam Score	3.3 score on a scale Standard Deviation 1.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=27 Participants 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. 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.
MNSI Physical Exam Score	3.2 score on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=26 Participants 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. 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.
Calf Muscle Performance	35 newton-meters Standard Deviation 15

PRIMARY outcome

Timeframe: Week 10

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

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=26 Participants 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. 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.
Calf Muscle Performance	44 newton-meters Standard Deviation 19

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=29 Participants 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. 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.
Physical Performance Test (PP) Score	31.5 score on a scale Standard Deviation 3.5

PRIMARY outcome

Timeframe: Week 10

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

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=29 Participants 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. 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.
Physical Performance Test (PP) Score	33.1 score on a scale Standard Deviation 2.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=15 Participants 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. 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.
PCr Resynthesis Rate in the Gastrocnemius Muscle Groups	35.4 mM/seconds Standard Deviation 21.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=15 Participants 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. 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.
PCr Resynthesis Rate in the Gastrocnemius Muscle Groups	32.3 mM/seconds Standard Deviation 21.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=28 Participants 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. 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.
Intramuscular Adipose Tissue (IMAT) Levels in the Gastrocnemius Muscle Groups	9.1 percentage of tissue Standard Deviation 4.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=28 Participants 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. 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.
Intramuscular Adipose Tissue (IMAT) Levels in the Gastrocnemius Muscle Groups	9 percentage of tissue Standard Deviation 4.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=28 Participants 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. 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.
IMAT Levels in the Soleus Muscle Groups	9.8 percentage of tissue Standard Deviation 4.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=28 Participants 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. 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.
IMAT Levels in the Soleus Muscle Groups	9.9 percentage of tissue Standard Deviation 4.2

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=17 Participants 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. 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.
Fractional Anisotropy (FA) in the Tibial Nerve	0.32 score on a scale Standard Deviation 0.07

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=17 Participants 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. 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.
Fractional Anisotropy (FA) in the Tibial Nerve	0.33 score on a scale Standard Deviation 0.05

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=17 Participants 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. 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.
Apparent Diffusion Coefficient (ADC) in the Tibial Nerve	1.76 x10^3 mm^2/s Standard Deviation 0.2

PRIMARY outcome

Timeframe: Week 10

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

Outcome measures

Outcome measures
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=17 Participants 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. 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.
Apparent Diffusion Coefficient (ADC) in the Tibial Nerve	1.81 x10^3 mm^2/s Standard Deviation 0.19

Adverse Events

Patients With Type 2 Diabetes and Clinical Symptoms of DPN

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Patients With Type 2 Diabetes and Clinical Symptoms of DPN n=44 participants at risk 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. 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.
Musculoskeletal and connective tissue disorders Muscle soreness	2.3% 1/44 • 10 Weeks
Metabolism and nutrition disorders Hyperglycemia	4.5% 2/44 • 10 Weeks
Musculoskeletal and connective tissue disorders Knee pain	2.3% 1/44 • 10 Weeks
Cardiac disorders Ventricular ectopy	2.3% 1/44 • 10 Weeks

Additional Information

Ryan Brown, PhD

NYU Langone Health

Phone: 2122633396

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place