Effects of Pulsatile Intravenous Insulin Therapy on Cardiac Disease in Patients With Diabetes
Withdrawn before enrolling · Phase 3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 heart disease in diabetic patients. Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion. A diabetic cardiac disease quality of life questionnaire is completed prior to the start of the treatment and monthly thereafter with detailed analysis performed to measure progress and outcomes. A carotid ultrasound and echocardiogram are performed at baseline and every six months to monitor progress.
Key facts
- Study ID
- NCT00539435
- Run by
- Florida Atlantic University
- People needed
- 0
- Starts
- 2007-09-01
- Expected to finish
- 2012-09-01
- 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 400 pts between male and female between the ages of 21 and 85 diagnosed with diabetes mellitus and cardiac disease
- 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
- Betty Tuller PhD — Boca Raton, Florida, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.