Effect of Pulsatile IV Insulin on Circulating Risk Markers of Vascular and Metabolic Complications in Pts With Diabetes
Diabetes Mellitus
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Pulsatile intravenous insulin, Oral carbohydrate loading, Respiratory Quotients, Hypoglycemia, Diabetic Complications, Circulating vascular and inflammatory markers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Florida Atlantic University Center for Complex Systems and Brain Sciences
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
2
1
Diabetic patients who meet inclusion criteria will be enrolled to start Pulsatile Intravenous Insulin Therapy on a weekly basis. Baseline testing will be performed and measured against continued testing every twelve months.
Circulating blood markers will be performed on diabetic control patients at baseline and every twelve months to compare and measure against patients treated with Pulsatile intravenous insulin therapy