Diabetic NeuropathyADAPTNCT02341261
Activity for Diabetic Polyneuropathy
A study testing Supervised Exercise and Counseling in people with Diabetic Neuropathy, run by University of Utah at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- Supervised Exercise and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2015to 15 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kansas
Kansas City, Kansas, 66160
University of Utah School of Medicine
Salt Lake City, Utah, 84121
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Neuropathy
- Being tested
- Standard Care Counseling, Supervised Exercise and Counseling
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Care CounselingBehavioural
Supervised Exercise and CounselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Standard Care Counseling |
| 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. Receives: Behavioral: Supervised Exercise and Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraepidermal Nerve Fiber Density (IENFD)
Measured: Baseline, 9 months, and 18 months
Change in Quality of Life (NQOL-DN) Questionnaire Results
Measured: Baseline, 9 months, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startNov 2015
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Virginia Commonwealth University
- Responsible party
- Principal investigator, Rob Singleton, University of Utah
- Investigators
- J R Singleton, Principal investigator, Rob.Singleton@hsc.utah.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341261
- Sponsor's protocol ID
- 00072011
- Other IDs
- R01DK064814
- Acronym
- ADAPT
- Status last verified
- Dec 2021
- First submitted
- 9 Jan 2015
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27417167
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity for Diabetic Polyneuropathy: the ADAPT Study
- ClinicalTrials.gov ID
- NCT02341261
- Acronym / sponsor ID
- ADAPT / 00072011
- Conditions
- Diabetic Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- University of Kansas, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Virginia Commonwealth University
- Study start
- Nov 2015
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care Counseling | Experimental | Behavioral: Standard Care CounselingParticipants 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. |
| Supervised Exercise and Counseling | Experimental | Behavioral: Supervised Exercise and CounselingParticipants 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Care Counseling | Behavioural | Standard Care Counseling |
| Supervised Exercise and Counseling | Behavioural | Supervised Exercise and Counseling |
Primary outcome
Change in Intraepidermal Nerve Fiber Density (IENFD)
Time frame: Baseline, 9 months, and 18 months
Change in Quality of Life (NQOL-DN) Questionnaire Results
Time frame: Baseline, 9 months, and 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Derived from this study: PubMed 27417167Kluding 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J R Singleton principal investigator
Rob.Singleton@hsc.utah.edu
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Exercise and Counseling in people with Diabetic Neuropathy, run by University of Utah at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intraepidermal Nerve Fiber Density (IENFD) (time frame: Baseline, 9 months, and 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02341261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.