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

Joslin Diabetes Center1 site in 1 country50 target enrollmentApril 2012

ConditionsDiabetic Polyneuropathy Weight Loss

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetic Polyneuropathy
Sponsor: Joslin Diabetes Center
Enrollment: 50
Locations: 1
Primary Endpoint: Change in Sural nerve conduction velocity
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2012

End Date

June 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Joslin Diabetes Center

Responsible Party

Principal Investigator

Osama Hamdy

Principal Investigator

Joslin Diabetes Center

Eligibility Criteria

Inclusion Criteria

•Inclusion of Intervention group:
•Men and Women with established Diabetes.
•BMI between 30-45 Kg/m2
•Age: 18-75 years old.
•Enrolled in the Why WAIT program
•Diabetes duration of at least 5 years
•Hb A1C of 6.5% or higher
•Inclusion of controls:
•Men and Women with established Diabetes.
•BMI between 30-45 Kg/m2

Exclusion Criteria

•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.
•Severe diabetic peripheral neuropathy as defined clinically.
•Severe peripheral vascular disease e.g absent dorsalis pedis pulsation.
•Recent weight loss/gain (10 pounds) during the past six months.
•Neuropathy due to other causes other than diabetes: Alcohol abuse, Liver/Renal disease, Toxic exposure, Inflammatory Disease, Nutritional and Vitamin deficiencies.
•Individuals with cardiac pacemakers.
•Women who are Pregnant or who think they might be pregnant.

Outcomes

Primary Outcomes

Change in Sural nerve conduction velocity

Time Frame: 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.