Evaluating the Effect of Diabetes Control Through Intensive Lifestyle Modifications on Diabetic Peripheral Neuropathy



Status:Completed
Conditions:Diabetic Neuropathy, Obesity Weight Loss, Neurology
Therapuetic Areas:Endocrinology, Neurology
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:April 2012
End Date:June 2015

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Evaluation of the Effect of Intensive Diabetes Control Through Non-Surgical Intensive Lifestyle Modifications and Weight Reduction on Diabetic Peripheral Neuropathy

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.


Inclusion Criteria:

Inclusion of Intervention group:

1. Men and Women with established Diabetes.

2. BMI between 30-45 Kg/m2

3. Age: 18-75 years old.

4. Enrolled in the Why WAIT program

5. Diabetes duration of at least 5 years

6. Hb A1C of 6.5% or higher

Inclusion of controls:

1. Men and Women with established Diabetes.

2. BMI between 30-45 Kg/m2

3. Age: 18-75 years old.

4. Diabetes duration of at least 5 years

5. Hb A1C of 6.5% or higher

Exclusion Criteria:

1. 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.

2. Severe diabetic peripheral neuropathy as defined clinically.

3. Severe peripheral vascular disease e.g absent dorsalis pedis pulsation.

4. Recent weight loss/gain (10 pounds) during the past six months.

5. Neuropathy due to other causes other than diabetes: Alcohol abuse, Liver/Renal
disease, Toxic exposure, Inflammatory Disease, Nutritional and Vitamin deficiencies.

6. Individuals with cardiac pacemakers.

7. Women who are Pregnant or who think they might be pregnant.
We found this trial at
1
site
One Joslin Place
Boston, Massachusetts 02215
617-309-2400
Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
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Boston, MA
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