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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01565317
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : February 23, 2016
Sponsor:
Collaborator:
NeuroMetrix, Inc.
Information provided by (Responsible Party):
Osama Hamdy, 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.

Condition or disease Intervention/treatment Phase
Diabetic Polyneuropathy Weight Loss Other: Weight Achievement and Intensive Treatment (Why WAIT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : April 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Sural Nerve Amplitude potential [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565317


Locations
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United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
NeuroMetrix, Inc.
Investigators
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Principal Investigator: Osama M Hamdy, MD., PhD Joslin Diabetes Center
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Responsible Party: Osama Hamdy, Principal Investigator, Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01565317    
Other Study ID Numbers: CHS #2011-16
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Polyneuropathies
Diabetic Neuropathies
Weight Loss
Body Weight Changes
Body Weight
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases