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

Completed · Not applicable

Conditions studied: Diabetic Polyneuropathy, Weight Loss

In brief

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.

Key facts

Study ID

NCT01565317

Run by

Joslin Diabetes Center

People needed

50

Starts

2012-04-01

Expected to finish

2015-06-01

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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.

Where it is running

• Joslin Diabetes Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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