Status:
TERMINATED
Effects of Pulsatile Insulin Delivery on Diabetic Neuropathy in Patients With Types 1 and 2 Diabetes Mellitus
Lead Sponsor:
Florida Atlantic University
Collaborating Sponsors:
Advanced Diabetes Treatment Centers
Global Infusions
Conditions:
Diabetes Mellitus, With Complications
Eligibility:
All Genders
20-90 years
Phase:
PHASE2
PHASE3
Brief Summary
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 ...
Detailed Description
Diabetic neuropathy (DN) is a progressive complication causing serious problems in 25%-40% of diabetic patients. Significant complications produce painful peripheral dysesthesias, loss of sensation, a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00228891
Start Date
February 1 2004
End Date
August 1 2009
Last Update
August 10 2016
Active Locations (1)
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1
Florida Atlantic University Center for Complex Systems and Brain Sciences
Boca Raton, Florida, United States, 33431