Status:
TERMINATED
Effects of Pulsatile IV Insulin Delivery on Diabetic Retinopathy 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
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Diabetic Retinopathy is the leading cause of blindness in the world. Previous studies have documented beneficial effects of physiologic administration of pulsatile insulin on a variety of diabetic com...
Detailed Description
Diabetic retinopathy is one of the leading causes of blindness in the world. Signs of retinopathy are detected in almost 100% of type 1 diabetic patients who have had their disease for at least 20 yea...
Eligibility Criteria
Inclusion
- We will include up to 500 patients both male and female over the age of 18 diagnosed with type 1 or type 2 diabetes mellitus.
- All patients must be diagnosed with type 1 or type 2 diabetes.
- Fundus photographs will be examined by an independent retinal specialist and the patients will be stratified into the three groups as outlined above.
- Endocrinologist must assess and approve patient for participation in this study
- Patient must have the ability to swallow without difficulty and 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 metabolic measurement cart for respiratory quotients
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00287651
Start Date
November 1 2005
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