Activity for Diabetic Polyneuropathy

  • STATUS
    Recruiting
  • End date
    Apr 25, 2022
  • participants needed
    140
  • sponsor
    Virginia Commonwealth University
Updated on 25 January 2021
polyneuropathy
peripheral neuropathy
diabetic peripheral neuropathy
diabetic neuropathy
diabetic polyneuropathy

Summary

The proposed study will randomize participants with diabetic peripheral neuropathy into two groups. One group of participants will receive standard-of-care counseling while the other group will undergo supervised exercise and counseling to increase physical activity.

Description

Type 2 diabetes (T2D) affects over 8% of Americans, and half will develop peripheral neuropathy, a progressive injury to the very longest nerves of the body. Our previous research has found that neuropathy can be detected early in its course and followed by examining nerves that reach to the skin using a small punch biopsy. These cutaneous nerves can be injured by high blood glucose, obesity and high triglycerides, but have the potential to regrow in response to treatments that improve these metabolic conditions. The proposed study will randomize participants with mild to moderate diabetic peripheral neuropathy to receive either generic annual counseling or an integrated program of moderate supervised exercise and actigraphy based anti sedentariness counseling.

Details
Condition DIABETIC NEUROPATHY, Peripheral Neuropathy
Treatment Standard Care Counseling, Supervised Exercise and Counseling
Clinical Study IdentifierNCT02341261
SponsorVirginia Commonwealth University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

T2D defined by ADA criteria
Peripheral neuropathy based on the Toronto Diabetic Neuropathy Expert Group consensus criteria for "Confirmed diabetic sensorimotor peripheral neuropathy
Moderate DPN severity with a UENS of 2-18
Age between 30 and 75
Under the care of an identified Primary Care Physician (PCP)

Exclusion Criteria

Any alternative cause for peripheral neuropathy. The following tests must have been found normal within the last 12 months or will be performed pre-randomization: vitamin B12, serum protein electrophoresis and immunofixation. ANA and TSH may be obtained if clinically indicated and not available from clinical records
Family history of a non-diabetic neuropathy in a first-degree relative
Severe or longstanding neuropathy: UENS > 18 or history of foot ulceration or amputation
Participants taking Coumadin or oral factor X or thrombin inhibitor therapy will be considered on an individual basis by the site investigator
Severe edema, dermatologic or lower extremity condition that would increase risk of skin biopsy
A serious medical condition that might shorten life span or prevent exercise
Subjects with obesity or hypertension considered in a dangerous range (BMI> 45, systolic BP >170, or diastolic BP >110) and those who fail a medically supervised graded maximal stress test will be excluded from the study for safety reasons
An inability to understand or cooperate with the procedures of the study
Females who are pregnant at screening or actively plan to become pregnant during the study period, because of the marked changes in metabolism anticipated during pregnancy
If ,in the investigators assessment, that participation in the study would be limited by a person's weight, size, or other physical condition
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