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Activity for Diabetic Polyneuropathy (ADAPT)

Primary Purpose

Diabetic Neuropathy

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standard Care Counseling

Supervised Exercise and Counseling

About this trial

This is an interventional treatment trial for Diabetic Neuropathy

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of KansasRecruiting
University of Utah School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Standard Care Counseling

Supervised Exercise and Counseling

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Intraepidermal Nerve Fiber Density (IENFD)

Change in Quality of Life (NQOL-DN) Questionnaire Results

Secondary Outcome Measures

Full Information

NCT ID

NCT02341261

First Posted

January 9, 2015

Last Updated

May 14, 2020

Sponsor

Virginia Commonwealth University

Collaborators

University of Kansas, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Utah

1. Study Identification

Unique Protocol Identification Number

NCT02341261

Brief Title

Activity for Diabetic Polyneuropathy

Acronym

ADAPT

Official Title

Activity for Diabetic Polyneuropathy: the ADAPT Study

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 2015 (undefined)

Primary Completion Date

April 2022 (Anticipated)

Study Completion Date

April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Virginia Commonwealth University

Collaborators

University of Kansas, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Utah

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Neuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard Care Counseling

Arm Type

Experimental

Arm Description

Arm Title

Supervised Exercise and Counseling

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Standard Care Counseling

Intervention Type

Behavioral

Intervention Name(s)

Supervised Exercise and Counseling

Primary Outcome Measure Information:

Title

Change in Intraepidermal Nerve Fiber Density (IENFD)

Time Frame

Baseline, 9 months, and 18 months

Title

Change in Quality of Life (NQOL-DN) Questionnaire Results

Time Frame

Baseline, 9 months, and 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brittney Holmberg

Phone

804-552-0014

Brittney.holmberg@vcuhealth.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

A. Gordon Smith, MD

Organizational Affiliation

Virginia Commonwealth University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jeff Hoover

jhoover3@kumc.edu

Facility Name

University of Utah School of Medicine

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84121

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cathy Revere

Phone

801-585-1737

cathy.revere@hsc.utah.edu

12. IPD Sharing Statement

Citations:

PubMed Identifier

27417167

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.

Results Reference

derived

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Activity for Diabetic Polyneuropathy

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