Status:
TERMINATED
Effect of Pulsatile IV Insulin on Circulating Risk Markers of Vascular and Metabolic Complications in Pts With Diabetes
Lead Sponsor:
Florida Atlantic University
Collaborating Sponsors:
Advanced Diabetes Treatment Centers
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
21-85 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine the effect of Pulsatile Intravenous Insulin therapy on circulating blood markers. These blood markers are selected due to their correlation to and possible pa...
Detailed Description
Insulin produces vasodilatory, anti inflammatory and anti thrombotic effects (1-4). . However the effects of pulsatile intravenous insulin delivery on circulating risk factors for vascular and metabol...
Eligibility Criteria
Inclusion
- We will include up to 500 patients both male and female over the age of 21 diagnosed with type 1 or type 2 diabetes mellitus
- All patients must have secondary complications caused by the diabetes and not responding to conventional medical management
- 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 perform breathe into machine for respiratory quotients
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00361907
Start Date
February 1 2005
End Date
August 1 2009
Last Update
August 9 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