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

• Sponsor: Joslin Diabetes Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01565317
• Collaborator: NeuroMetrix, Inc. (Industry)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 38
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Polyneuropathy; Weight Loss	Other: Weight Achievement and Intensive Treatment (Why WAIT)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: Evaluation of the Effect of Intensive Diabetes Control Through Non-Surgical Intensive Lifestyle Modifications and Weight Reduction on Diabetic Peripheral Neuropathy
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
No Intervention: Control Group Matched control group will be recruited from obese patients with diabetes followed at Joslin Clinic. This group will receive the routine standard diabetes care.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Joslin Diabetes Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Joslin Diabetes Center
• NeuroMetrix, Inc.

Investigators

• Principal Investigator: Osama M Hamdy, MD., PhD, Joslin Diabetes Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Osama Hamdy, Principal Investigator, Joslin Diabetes Center
• ClinicalTrials.gov Identifier: NCT01565317
• Other Study ID Numbers: CHS #2011-16
• First Posted: Mar 28, 2012
• Last Update Posted: Feb 23, 2016
• Last Verified: Feb 1, 2016

• Additional relevant MeSH terms: Peripheral Nervous System Diseases; Polyneuropathies; Diabetic Neuropathies; Weight Loss

Study Results

No Results Posted as of Feb 23, 2016