Reversing Diabetic Peripheral Neuropathy Through Exercise
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ClinicalTrials.gov Identifier: NCT03686423
Recruitment Status :
(patient cohort consists of diabetic patients, which is a co-risk factor for covid-19)
This cross-over design study proposes an innovative multinuclear MRI approach to gain mechanistic insight into the exercise-associated adaptations in lower leg muscle function and peripheral nerve integrity of patients with diabetic peripheral neuropathy (DPN). Currently, there are no therapies to prevent or reverse the progress of DPN. This study will use novel multinuclear MRI technology to understand how exercise affects skeletal muscle and peripheral nerve integrity and function in patients with DPN. This study will prescribe a 4-week non-exercise phase followed by a 10-week exercise program (with both aerobic and strengthening components) to 40 DPN patients who will receive personal supervision from health professionals.
Change in Body mass index (BMI) [ Time Frame: 10 Weeks ]
measure that uses your height and weight to work out if your weight is healthy. The BMI calculation divides an adult's weight in kilograms by their height in metres squared. For example, A BMI of 25 means 25kg/m2.
Change in glycosylated hemoglobin (HbA1c) [ Time Frame: 10 Weeks ]
The glycosylated hemoglobin test shows what a person's average blood glucose level was for the 2 to 3 months before the test. This can help determine how well a person's diabetes is being controlled over time.
Change in C-reactive protein [ Time Frame: 10 Weeks ]
Used to evaluate your risk of developing coronary artery disease, a condition in which the arteries of your heart are narrowed. ... A simple blood test measures C-reactive protein.
MNSI symptom questionnaire [ Time Frame: 10 Weeks ]
15 questions. 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 aesthenia and are not included in scoring.
MNSI physical exam score [ Time Frame: 10 Weeks ]
Indicates abnormalities in the appearance of the feet, vibration sense, reflexes, and monofilament sensation
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Layout table for eligibility information
Ages Eligible for Study:
40 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
40 patients with DPN
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
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
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