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Activity for Diabetic Polyneuropathy (ADAPT)

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ClinicalTrials.gov Identifier: NCT02341261
Recruitment Status : Recruiting
First Posted : January 19, 2015
Last Update Posted : March 12, 2019
Sponsor:
Collaborators:
University of Kansas
University of Utah
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy Behavioral: Standard Care Counseling Behavioral: Supervised Exercise and Counseling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Activity for Diabetic Polyneuropathy: the ADAPT Study
Study Start Date : November 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Arm Intervention/treatment
Experimental: Standard Care Counseling
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.
Behavioral: Standard Care Counseling
Experimental: Supervised Exercise and Counseling
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.
Behavioral: Supervised Exercise and Counseling



Primary Outcome Measures :
  1. Change in Intraepidermal Nerve Fiber Density (IENFD) [ Time Frame: Baseline, 9 months, and 18 months ]
  2. Change in Quality of Life (NQOL-DN) Questionnaire Results [ Time Frame: Baseline, 9 months, and 18 months ]


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341261


Contacts
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Contact: Brittney Holmberg 804-628-6439 Brittney.holmberg@vcuhealth.org

Locations
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United States, Kansas
University of Kansas Recruiting
Kansas City, Kansas, United States, 66160
Contact: Jeff Hoover       jhoover3@kumc.edu   
United States, Utah
University of Utah School of Medicine Recruiting
Salt Lake City, Utah, United States, 84121
Contact: Cathy Revere    801-585-1737    cathy.revere@hsc.utah.edu   
United States, Virginia
Virginia Commonwealth University Not yet recruiting
Richmond, Virginia, United States, 23298
Contact: Brittney Holmberg         
Sponsors and Collaborators
Virginia Commonwealth University
University of Kansas
University of Utah
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: A. Gordon Smith, MD Virginia Commonwealth University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02341261     History of Changes
Other Study ID Numbers: HM20015791
R01DK064814 ( U.S. NIH Grant/Contract )
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Diabetic Neuropathies
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases