Effects of Pulsatile Insulin Delivery on Diabetic Neuropathy in Patients With Types 1 and 2 Diabetes Mellitus
Diabetes Mellitus, With Complications
About this trial
This is an interventional treatment trial for Diabetes Mellitus, With Complications focused on measuring Pulsatile intravenous insulin, Oral carbohydrate loading, Respiratory Quotients, Hypoglycemia, Diabetic Neuropathy
Eligibility Criteria
Inclusion Criteria: The researchers will include up to 500 patients both male and female between the ages of 20 and 90 diagnosed with type 1 or type 2 diabetes mellitus. All patients were diagnosed by their endocrinologists as having diabetic neuropathy All patients had failed conventional treatment for diabetic neuropathy 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 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 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
Patients with diagnosed diabetic neuropathy will receive objective baseline testing and follow up testing every six months after the start of Pulsatile intravenous insulin therapy to monitor and assess diabetic neuropathy.
Control patients with diabetic neuropathy will receive objective testing at baseline and every six months to compare and measure results with patients who are receiving pulsatile intravenous insulin therapy.