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

Joslin Diabetes Center50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Diabetic Polyneuropathy Weight Loss

Interventions

Weight Achievement and Intensive Treatment (Why WAIT)OTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Joslin Diabetes Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Change in Sural nerve conduction velocity

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.

Time frame: Baseline, at 3 months, at 6 months, at 12 months

Secondary Outcomes

Change in Sural Nerve Amplitude potential

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.

Time frame: Baseline, at 3 months, at 6 months, at 12 months

Data from ClinicalTrials.gov

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