Effects of Pulsatile Intravenous Insulin Delivery on Diabetic Neuropathy in pATIENTS (Pts) With Type 1 and Type 2 Diabetes

Withdrawn before enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Diabetic Neuropathy

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 therapy in affected 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 IV insulin therapy on diabetic neuropathy.

Key facts

Study ID

NCT00228904

Run by

Florida Atlantic University

People needed

0

Starts

2005-02-01

Expected to finish

2011-10-01

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…

• 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.
• All patients are taking oral agents and/or insulin for diabetic control.
• All patients are under an endocrinologist's supervision for their diabetes management.
• Endocrinologist must assess and approve patient for participation in this study.
• All patients must demonstrate the ability to swallow without difficulty and the 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
• HIV positive
• 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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