Pilot Study of Exercise and Peripheral Nerve Function in People With Diabetes - ENRGy2 Addendum

Completed · Not applicable

Conditions studied: Diabetic Neuropathy

In brief

This is an amendment to study posting NCT00970060. Based on preliminary results from that study is was determined there needs to be a follow-up exercise intervention study. This study has two additional aims than the original study. The objectives are to determine is a prolonged exercise routine, 16-weeks, paired with refined measures of effectiveness positively impact people with diabetic neuropathy.

Key facts

Study ID

NCT01764373

Run by

University of Kansas

People needed

19

Starts

2012-06-01

Expected to finish

2013-07-01

Last updated by the study team

2013-09-27

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 40-70
• Type 2 diabetes
• Peripheral neuropathy

You may not qualify if…

• serious cardiac pathology such as recent myocardial infarction or heart surgery, uncontrolled cardiac arryhthmia, hypertrophic cardiomyopathy symptomatic aortic stenosis or heart failure, unstable angina, acute pulmonary embolus or myocarditis, conduction abnormalities, or mitral valve prolapse
• serious musculoskeletal problems that would limit ability to exercise
• skin conditions, circulatory insufficiency, or open wounds in the leg that would interfere with healing from the biopsy
• open wounds on the weight bearing surface of the feet
• not able to ambulate independently
• stroke or other central nervous system pathology
• stage 2 hypertension (resting blood pressure > 160 systolic or > 100 diastolic)
• lidocaine allergy
• anticipated difficulty with blood clotting due to Coumadin(Warfarin) use or blood clotting disorder
• body weight > 450 lbs
• inadequate cognition and communication abilities, defined as < 24 on the Mini Mental Status Exam (MMSE)
• pregnant or planning on becoming pregnant in the 18 weeks following enrollment

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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