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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01565317
• Other study ID #: CHS #2011-16
• Status: Completed
• Phase: N/A
• First received: March 26, 2012
• Last updated: February 22, 2016
• Start date: April 2012
• Est. completion date: June 2015

Study information

• Verified date: February 2016
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Polyneuropathy
• Peripheral Nervous System Diseases
• Polyneuropathies
• Weight Loss

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Joslin Diabetes Center	NeuroMetrix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, at 3 months, at 6 months, at 12 months	No
Secondary	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.	Baseline, at 3 months, at 6 months, at 12 months	No