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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK064814 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Kansas | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| University of Utah | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care Counseling | Experimental | 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. |
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| Supervised Exercise and Counseling | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Care Counseling | Behavioral |
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| Supervised Exercise and Counseling |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intraepidermal Nerve Fiber Density (IENFD) | Baseline, 9 months, and 18 months | |
| Change in Quality of Life (NQOL-DN) Questionnaire Results | Baseline, 9 months, and 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brittney Holmberg | Contact | 804-552-0014 | Brittney.holmberg@vcuhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| A. Gordon Smith, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas | Recruiting | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27417167 | Derived | 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. |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| Behavioral |
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| University of Utah School of Medicine | Recruiting | Salt Lake City | Utah | 84121 | United States |
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| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D005159 | Health Care Facilities Workforce and Services |