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Completed

NCT Number: NCT01565317

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

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.

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Key information

Conditions

Diabetic Polyneuropathy Body Weight Body Weight Changes Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Weight Loss

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion of Intervention group:

  • 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

Inclusion of controls:

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

  • NeuroMetrix, Inc.

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 28, 2012
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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