N/A
N=44
Reversing Diabetic Peripheral Neuropathy Through Exercise
Peripheral Neuropathy · Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03686423 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Body Mass Index (BMI) — 30.7 kg/m^2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise Program (Procedure)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Mass Index (BMI) |
30.7 | — |
| PRIMARY Change From Baseline in Body Mass Index (BMI) |
30.2 | — |
| PRIMARY Glycosylated Hemoglobin (HbA1c) |
7.3 | — |
| PRIMARY Glycosylated Hemoglobin (HbA1c) |
7.3 | — |
| PRIMARY C-Reactive Protein Levels |
4.6 | — |
| PRIMARY C-Reactive Protein Levels |
4.6 | — |
| PRIMARY Michigan Neuropathy Screening Instrument (MNSI) Symptom Questionnaire |
4.8 | — |
| PRIMARY Michigan Neuropathy Screening Instrument (MNSI) Symptom Questionnaire |
4.8 | — |
| PRIMARY MNSI Physical Exam Score |
3.2 | — |
| PRIMARY MNSI Physical Exam Score |
3.2 | — |
| PRIMARY Calf Muscle Performance |
44 | — |
| PRIMARY Calf Muscle Performance |
44 | — |
| PRIMARY Physical Performance Test (PP) Score |
33.1 | — |
| PRIMARY Physical Performance Test (PP) Score |
33.1 | — |
| PRIMARY PCr Resynthesis Rate in the Gastrocnemius Muscle Groups |
32.3 | — |
| PRIMARY PCr Resynthesis Rate in the Gastrocnemius Muscle Groups |
32.3 | — |
| PRIMARY Intramuscular Adipose Tissue (IMAT) Levels in the Gastrocnemius Muscle Groups |
9 | — |
| PRIMARY Intramuscular Adipose Tissue (IMAT) Levels in the Gastrocnemius Muscle Groups |
9 | — |
| PRIMARY IMAT Levels in the Soleus Muscle Groups |
9.9 | — |
| PRIMARY IMAT Levels in the Soleus Muscle Groups |
9.9 | — |
| PRIMARY Fractional Anisotropy (FA) in the Tibial Nerve |
0.33 | — |
| PRIMARY Fractional Anisotropy (FA) in the Tibial Nerve |
0.33 | — |
| PRIMARY Apparent Diffusion Coefficient (ADC) in the Tibial Nerve |
1.81 | — |
| PRIMARY Apparent Diffusion Coefficient (ADC) in the Tibial Nerve |
1.81 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT03686423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.