Effects of Pulsatile Insulin Delivery on Diabetic Neuropathy in Patients With Types 1 and 2 Diabetes Mellitus

Stopped early · Phase 2/Phase 3

Conditions studied: Diabetes Mellitus, With Complications

In brief

Diabetic neuropathy is a progressive complication causing serious problems in 25-40% of diabetic patients. Anecdotal reports have indicated improvement with pulsatile IV insulin in patients otherwise resistant to all conventional therapies. Significant complications produce painful peripheral dysesthesias, loss of sensation and gastroparesis. This study is designed to test the effectiveness of pulsatile insulin delivery on diabetic neuropathy.

Key facts

Study ID

NCT00228891

Run by

Florida Atlantic University

People needed

152

Starts

2004-02-01

Expected to finish

2009-08-01

Last updated by the study team

2016-08-10

Who can join

Age: 20 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The researchers will include up to 500 patients both male and female between the ages of 20 and 90 diagnosed with type 1 or type 2 diabetes mellitus.
• All patients were diagnosed by their endocrinologists as having diabetic neuropathy
• All patients had failed conventional treatment for diabetic neuropathy
• Taking oral agents and/or insulin for diabetic control
• Under an Endocrinologists supervision for their diabetes management. Endocrinologist must assess and approve patient for participation in this study
• Ability to swallow without difficulty
• Ability to commit to the weekly time requirements associated with the study

You may not qualify if…

• Other causes of complications not related to diabetes
• Lack of intravenous access
• Pregnancy
• Alcohol abuse, drug addiction or the use of illegal drugs
• Positive HIV
• Inability to breathe into machine for respiratory quotients

Where it is running

• Florida Atlantic University Center for Complex Systems and Brain Sciences — Boca Raton, Florida, United States

Full record on ClinicalTrials.gov

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