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

Not Applicable

Completed

• Conditions: Diabetic Polyneuropathy; Weight Loss
• Interventions: Other: Weight Achievement and Intensive Treatment (Why WAIT)

• Registration Number: NCT01565317
• Lead Sponsor: Joslin Diabetes Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-26
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-28
• Study Start: 2012-04
• Primary Completion: 2015-05
• Study Completion: 2015-06
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive Treatment (Why WAIT)	Weight 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States