Status:
TERMINATED
Effect Pulsatile IV Insulin Therapy on the Quality of Life in Patients With Types 1 and 2 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 if restoring normal metabolic function in patients with either type I or type II diabetes can improve the impact of the consequences of diabetic complications...
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
- The researchers will include up to 200 patients both male and female between the ages of 21 and 85 diagnosed with type 1 or type 2 diabetes mellitus.
- Self reporting or diagnosed with significant complications resulting from diabetes
- 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
- Inability to respond to 44 item questionnaire
- 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 :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00228878
Start Date
March 1 2003
End Date
August 1 2009
Last Update
August 10 2016
Active Locations (1)
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1
Florida Atlantic University
Boca Raton, Florida, United States, 33487