Activity for Diabetic Polyneuropathy

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.

Inclusion Criteria:

1. T2D defined by ADA criteria.

2. Peripheral neuropathy based on the Toronto Diabetic Neuropathy Expert Group consensus
criteria for "Confirmed diabetic sensorimotor peripheral neuropathy".

3. Moderate DPN severity with a UENS of 2-18.

4. Age between 30 and 75.

5. Under the care of an identified Primary Care Physician (PCP).

Exclusion Criteria:

1. 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.

2. Family history of a non-diabetic neuropathy in a first-degree relative.

3. Severe or longstanding neuropathy: UENS > 18 or history of foot ulceration or
amputation.

4. Participants taking Coumadin or oral factor X or thrombin inhibitor therapy will be
considered on an individual basis by the site investigator.

5. Severe edema, dermatologic or lower extremity condition that would increase risk of
skin biopsy.

6. A serious medical condition that might shorten life span or prevent exercise.

7. 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.

8. An inability to understand or cooperate with the procedures of the study

9. 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.

10. If ,in the investigators assessment, that participation in the study would be limited
by a person's weight, size, or other physical condition.