Effects of Pulsatile Intravenous Insulin Therapy on Metabolic Integrity in Patients With Diabetes Mellitus
Stopped early · Phase 2/Phase 3
Conditions studied: Diabetes Mellitus, With Complications
In brief
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 on the overall quality of life of diabetic patients. Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion. A diabetic quality of life questionnaire is completed prior to the start of the treatment and quarterly thereafter with detailed analysis performed to measure progress and outcomes
Key facts
- Study ID
- NCT00539409
- Run by
- Florida Atlantic University
- People needed
- 152
- Starts
- 2006-11-01
- Expected to finish
- 2009-08-01
- Last updated by the study team
- 2016-08-10
Who can join
Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The researchers will include up to 750 pts between male and female between -the ages of 21 and 85 diagnosed with diabetes mellitus
- Self reporting or diagnosed with significant complications resulting from diabetes
- Taking oral agents and/or insulin for diabetic control
- Under an Endocrinologist supervision for their diabetes management, Endocrinologist must assess and approve pt for participation in this study
- Ability to swallow without difficulty
- Ability to perform Respiratory Quotient requirements by breathing into a mask for 3 minutes at a time
You may not qualify if…
- Lack of Intravenous access
- Pregnancy
- Alcohol abuse, drug addiction or the use of illegal drugs
- Active liver disease
- Active chemotherapy
- Positive HIV
- Inability to breathe into a respiratory quotient machine
Where it is running
- Florida Atlantic University — Boca Raton, Florida, United States
Full record on ClinicalTrials.gov
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