Evaluating the Effect of Diabetes Control Through Intensive Lifestyle Modifications on Diabetic P… (NCT01565317) | Clinical Trial Compass
CompletedNot Applicable
Evaluating the Effect of Diabetes Control Through Intensive Lifestyle Modifications on Diabetic Peripheral Neuropathy
United States50 participantsStarted 2012-04
Plain-language summary
The purpose of this study is to find out the impact of improving diabetes control through weight reduction and lifestyle changes on a common diabetes complication called peripheral neuropathy.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Men and Women with established Diabetes.
✓. BMI between 30-45 Kg/m2
✓. Age: 18-75 years old.
✓. Enrolled in the Why WAIT program
✓. Diabetes duration of at least 5 years
✓. Hb A1C of 6.5% or higher
✓. Men and Women with established Diabetes.
✓. BMI between 30-45 Kg/m2
Exclusion criteria
✕. Anatomic changes that preclude the measurement of the nerve conduction: foot deformities, open skin injuries/ulcers, amputations and placement of surgical plates and screws in the ankle and lower leg (tibial) area.
✕. Severe diabetic peripheral neuropathy as defined clinically.
✕. Severe peripheral vascular disease e.g absent dorsalis pedis pulsation.
✕. Recent weight loss/gain (10 pounds) during the past six months.
✕. Neuropathy due to other causes other than diabetes: Alcohol abuse, Liver/Renal disease, Toxic exposure, Inflammatory Disease, Nutritional and Vitamin deficiencies.
✕. Individuals with cardiac pacemakers.
What they're measuring
1
Change in Sural nerve conduction velocity
Timeframe: Baseline, at 3 months, at 6 months, at 12 months