Activity for Diabetic Polyneuropathy (ADAPT)

Virginia Commonwealth University (VCU)

Status: Unknown

Conditions: Diabetic Neuropathy

Treatments: Behavioral: Supervised Exercise and Counseling; Behavioral: Standard Care Counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02341261

HM20015791

R01DK064814 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

140 participants in 2 patient groups

Standard Care Counseling

Experimental group

Description:

Participants randomized to the control group will receive diet and exercise counseling at baseline and 9 months. Participants will wear an ActivePAL for 7 days at baseline, 9 months, and 18 months without stimulation.

Treatment:

Behavioral: Standard Care Counseling

Supervised Exercise and Counseling

Experimental group

Description:

Participants randomized to the intervention will perform supervised aerobic, resistance and balance training twice weekly for 12 weeks, and weekly thereafter. Actigraphy-based counseling to reduce sedentary behavior will follow a similar taper. Daily text messages, "tweets", emails, and social media posts at random times during waking hours will be used to provide reminders and motivational messages. Participants will have 11 separate 7-day continuous ActivePAL training session incorporating vibrostimulatory feedback spread across the treatment period.

Treatment:

Behavioral: Supervised Exercise and Counseling