Clinical trial NCT02341261: Activity for Diabetic Polyneuropathy
Official title: Activity for Diabetic Polyneuropathy: the ADAPT Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Neuropathy
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: University of Kansas
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Utah
First posted: 2015-01-19
Enrollment: 140
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Intraepidermal Nerve Fiber Density (IENFD)
timeFrame: Baseline, 9 months, and 18 months
measure: Change in Quality of Life (NQOL-DN) Questionnaire Results
timeFrame: Baseline, 9 months, and 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas
state: Kansas
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
Study officials:
affiliation: Virginia Commonwealth University
name: A. Gordon Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kluding PM, Singleton JR, Pasnoor M, Dimachkie MM, Barohn RJ, Smith AG, Marcus RL. Activity for Diabetic Polyneuropathy (ADAPT): Study Design and Protocol for a 2-Site Randomized Controlled Trial. Phys Ther. 2017 Jan 1;97(1):20-31. doi: 10.2522/ptj.20160200.