Status:
TERMINATED
Clinical Effects of Pulsatile Insulin Delivery on Cognitive Function- Phase 1
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
To determine if restoring normal metabolic function in patients with either Type I or Type II Diabetes can improve overall cognitive function. Patients are treated once a week with pulsatile intraveno...
Detailed Description
It is known that the glucose metabolic pathway (glycolysis) is the primary fuel generator in the brain and nerve tissue, the heart and vascular tissue, the eye, the kidney and the liver Deficient meta...
Eligibility Criteria
Inclusion
- diagnosed with type 1 or type 2 diabetes mellitus.
- Self reporting or diagnosed with memory changes
- Taking oral agents and/or insulin for diabetic control
- Under Endocrinologist's supervision for 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 cognitive impairment not related to diabetes
- Inability to take cognitive testing
- 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 :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00228865
Start Date
June 1 2003
End Date
August 1 2009
Last Update
August 10 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Florida Atlantic University
Boca Raton, Florida, United States, 33431