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

Not Applicable

Completed

• Conditions: Diabetic Polyneuropathy; Weight Loss

• 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

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