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

NCT01565317 | Completed

• 1 other identifier: CHS #2011-16
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Polyneuropathy; Weight Loss

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in Sural Nerve Amplitude potential

  Baseline, at 3 months, at 6 months, at 12 months

Study Arms (2)

Intensive Treatment (Why WAIT)

EXPERIMENTAL

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)

Control Group

NO INTERVENTION

Matched control group will be recruited from obese patients with diabetes followed at Joslin Clinic. This group will receive the routine standard diabetes care.

Interventions

Weight Achievement and Intensive Treatment (Why WAIT) OTHER

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.

Intensive Treatment (Why WAIT)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Men and Women with established Diabetes.
• BMI between 30-45 Kg/m2
• Age: 18-75 years old.
• Diabetes duration of at least 5 years
• Hb A1C of 6.5% or higher

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joslin Diabetes Center: lead
• NeuroMetrix, Inc.: collaborator

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Weight Loss

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Osama M Hamdy, MD., PhD

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: March 28, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 23, 2026

Record last verified: 2016-02

Locations

US (1)