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Activity for Diabetic Polyneuropathy: The ADAPT Study

This study will compare two different exercise and diet programs for Type 2 diabetic patients with diabetic neuropathy. Half of participants will be assigned at random to receive the diet and exercise counseling, typically provided to patients with diabetes while the other half of participants will receive supervised exercise and activity counseling, together with more intensive diet counseling. The study's primary goal is to compare the change in the number of small nerves that reach to the surface of the skin, as measured by skin biopsy, between the two treatment groups. The study will also compare the results of quality of life questionnaires and other measurements in the two treatment groups after 18 months.

Eligibility Criteria

You may be eligible for this study if you:
  • have Type 2 diabetes
  • are 30-75 years of age
  • have peripheral neuropathy (symptoms of numbness or pain in your feet due to diabetes)
 
You may not be eligible for this study if you:
  • have peripheral neuropathy because of something other than Type 2 diabetes
  • have a medical problem that prevents you from participating in exercise
  • take coumadin or oral factor X or thrombin inhibitor therapy
 
What is Involved?
If you are eligible for the study, you will be need to attend 3 assessment sessions, then you will be put into one of two groups. One group will receive diet and exercise counselling typically provided to patients with diabetes and other group will undergo supervised exercise and counselling to increase physical activity and reduce sedentary behavior. 
 

Principal Investigator

Patricia Kluding, PhD

Study Contact

Jeff Hoover, jhoover3@kumc.edu, 913-214-2165

Estimated Completion Date

Wednesday, April 1, 2020

ClinicalTrials.gov #

NCT02341261
01/05/2016