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Reversing Diabetic Peripheral Neuropathy Through Exercise

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03686423
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : October 14, 2021
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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Brief Summary:
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.

Condition or disease
Peripheral Neuropathy Diabetes

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Reversing Diabetic Peripheral Neuropathy Through Exercise
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. MNSI physical exam score [ Time Frame: 10 Weeks ]
    Indicates abnormalities in the appearance of the feet, vibration sense, reflexes, and monofilament sensation


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
40 patients with DPN
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686423


Contacts
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Contact: Katherine Medina 646-501-0086 Katherine.medina@nyulangone.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Katherine Medina    646-501-0086    Katherine.medina@nyulangone.org   
Principal Investigator: Ryan Brown, PhD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Ryan Brown, PhD NYU Langone Health
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03686423    
Other Study ID Numbers: 18-00527
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Exercise
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases