Diabetic Polyneuropathy, Weight Loss
Conditions
Brief 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.
Interventions
OTHERWeight Achievement and Intensive Treatment (Why WAIT)
Weight Achievement and Intensive Treatment (Why WAIT) is a 12 -week multidisciplinary program for weight control and intensive diabetes management designed by the Joslin Diabetes Center for application in a multidisciplinary diabetes practice environment. Participants will be enrolled in a 12-week multidisciplinary intensive weight management including diet, exercise, behavioral and educational support. Participants will be enrolled in cohorts of 10-15 participants to encourage group interaction and support. Subjects will choose to come to the Joslin clinic every Tuesday or Wednesday evening for 2 hours. Participants will exercise for an hour and will attend a didactic session in the areas of nutrition, exercise and behavioral modifications.
Sponsors
Joslin Diabetes Center
NeuroMetrix, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sural nerve conduction velocity | Baseline, at 3 months, at 6 months, at 12 months | The NCstat DPNCheck device(an FDA approved device) measures the sural nerve conduction velocity. The sural nerve conduction velocity is the gold standard in assessing diabetic peripheral neuropathy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sural Nerve Amplitude potential | Baseline, at 3 months, at 6 months, at 12 months | The NCstat DPNCheck device(an FDA approved device) measures the sural nerve Amplitude potential. The sural nerve is the gold standard in assessing diabetic peripheral neuropathy. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOROsama M Hamdy, MD., PhD
Joslin Diabetes Center
Outcome results
None listed