- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02341261
Activity for Diabetic Polyneuropathy (ADAPT)
May 14, 2020 updated by: Virginia Commonwealth University
Activity for Diabetic Polyneuropathy: the ADAPT Study
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Brittney Holmberg
- Phone Number: 804-552-0014
- Email: Brittney.holmberg@vcuhealth.org
Study Locations
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Kansas
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Kansas City, Kansas, United States, 66160
- Recruiting
- University of Kansas
-
Contact:
- Jeff Hoover
- Email: jhoover3@kumc.edu
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Utah
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Salt Lake City, Utah, United States, 84121
- Recruiting
- University of Utah School of Medicine
-
Contact:
- Cathy Revere
- Phone Number: 801-585-1737
- Email: cathy.revere@hsc.utah.edu
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- T2D defined by ADA criteria.
- Peripheral neuropathy based on the Toronto Diabetic Neuropathy Expert Group consensus criteria for "Confirmed diabetic sensorimotor peripheral neuropathy".
- Moderate DPN severity with a UENS of 2-18.
- Age between 30 and 75.
- Under the care of an identified Primary Care Physician (PCP).
Exclusion Criteria:
- 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.
- Family history of a non-diabetic neuropathy in a first-degree relative.
- Severe or longstanding neuropathy: UENS > 18 or history of foot ulceration or amputation.
- Participants taking Coumadin or oral factor X or thrombin inhibitor therapy will be considered on an individual basis by the site investigator.
- Severe edema, dermatologic or lower extremity condition that would increase risk of skin biopsy.
- A serious medical condition that might shorten life span or prevent exercise.
- 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.
- An inability to understand or cooperate with the procedures of the study
- 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.
- If ,in the investigators assessment, that participation in the study would be limited by a person's weight, size, or other physical condition.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Intraepidermal Nerve Fiber Density (IENFD)
Time Frame: Baseline, 9 months, and 18 months
|
Baseline, 9 months, and 18 months
|
Change in Quality of Life (NQOL-DN) Questionnaire Results
Time Frame: Baseline, 9 months, and 18 months
|
Baseline, 9 months, and 18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: A. Gordon Smith, MD, Virginia Commonwealth University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Anticipated)
April 1, 2022
Study Completion (Anticipated)
April 1, 2022
Study Registration Dates
First Submitted
January 9, 2015
First Submitted That Met QC Criteria
January 13, 2015
First Posted (Estimate)
January 19, 2015
Study Record Updates
Last Update Posted (Actual)
May 18, 2020
Last Update Submitted That Met QC Criteria
May 14, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20015791
- R01DK064814 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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