Activity for Diabetic Polyneuropathy

Diabetic Neuropathy Clinical Trial

— ADAPT  

Official title:

Activity for Diabetic Polyneuropathy: the ADAPT Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02341261
• Other study ID #: HM20015791
• Secondary ID: R01DK064814
• Status: Recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: April 2022

Study information

• Verified date: May 2020
• Source: Virginia Commonwealth University
• Contact: Brittney Holmberg
• Phone: 804-552-0014
• Email: Brittney.holmberg[@]vcuhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy
• Polyneuropathies

Intervention

Behavioral:
• Standard Care Counseling

• Supervised Exercise and Counseling

Locations

Country	Name	City	State
United States	University of Kansas	Kansas City	Kansas
United States	University of Utah School of Medicine	Salt Lake City	Utah

Sponsors (4)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Kansas, University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Intraepidermal Nerve Fiber Density (IENFD)		Baseline, 9 months, and 18 months
Primary	Change in Quality of Life (NQOL-DN) Questionnaire Results		Baseline, 9 months, and 18 months