Activity for Diabetic Polyneuropathy

Status unconfirmed · Not applicable

Conditions studied: Diabetic Neuropathy

In brief

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.

Key facts

Study ID

NCT02341261

Run by

Virginia Commonwealth University

People needed

140

Starts

2015-11-01

Expected to finish

2022-04-01

Last updated by the study team

2020-05-18

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• University of Kansas — Kansas City, Kansas, United States (enrolling)
• University of Utah School of Medicine — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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