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

Joslin Diabetes Center

Status: Completed

Conditions: Weight Loss; Diabetic Polyneuropathy

Treatments: Other: Weight Achievement and Intensive Treatment (Why WAIT)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01565317

CHS #2011-16

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 2 patient groups

Intensive Treatment (Why WAIT)

Experimental group

Description:

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.

Treatment:

Other: Weight Achievement and Intensive Treatment (Why WAIT)

Control Group

No Intervention group

Description:

Matched control group will be recruited from obese patients with diabetes followed at Joslin Clinic. This group will receive the routine standard diabetes care.