Clinical trial NCT03686423: Reversing Diabetic Peripheral Neuropathy Through Exercise
Official title: Reversing Diabetic Peripheral Neuropathy Through Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
Diabetes
Keywords: Exercise
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-09-27
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Baseline
measure: Change From Baseline in Body Mass Index (BMI)
timeFrame: Week 10
measure: Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline
measure: Glycosylated Hemoglobin (HbA1c)
timeFrame: Week 10
measure: C-Reactive Protein Levels
timeFrame: Baseline
measure: C-Reactive Protein Levels
timeFrame: Week 10
measure: Michigan Neuropathy Screening Instrument (MNSI) Symptom Questionnaire
timeFrame: Baseline
measure: Michigan Neuropathy Screening Instrument (MNSI) Symptom Questionnaire
timeFrame: Week 10
measure: MNSI Physical Exam Score
timeFrame: Baseline
measure: MNSI Physical Exam Score
timeFrame: Week 10
measure: Calf Muscle Performance
timeFrame: Baseline
measure: Calf Muscle Performance
timeFrame: Week 10
measure: Physical Performance Test (PP) Score
timeFrame: Baseline
measure: Physical Performance Test (PP) Score
timeFrame: Week 10
measure: PCr Resynthesis Rate in the Gastrocnemius Muscle Groups
timeFrame: Baseline
measure: PCr Resynthesis Rate in the Gastrocnemius Muscle Groups
timeFrame: Week 10
measure: Intramuscular Adipose Tissue (IMAT) Levels in the Gastrocnemius Muscle Groups
timeFrame: Baseline
measure: Intramuscular Adipose Tissue (IMAT) Levels in the Gastrocnemius Muscle Groups
timeFrame: Week 10
measure: IMAT Levels in the Soleus Muscle Groups
timeFrame: Baseline
measure: IMAT Levels in the Soleus Muscle Groups
timeFrame: Week 10
measure: Fractional Anisotropy (FA) in the Tibial Nerve
timeFrame: Baseline
measure: Fractional Anisotropy (FA) in the Tibial Nerve
timeFrame: Week 10
measure: Apparent Diffusion Coefficient (ADC) in the Tibial Nerve
timeFrame: Baseline
measure: Apparent Diffusion Coefficient (ADC) in the Tibial Nerve
timeFrame: Week 10
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Ryan Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References: