Abstract
The mechanisms behind pulsatile insulin release in healthy individuals and early loss of insulin pulsatility in patients with diabetes mellitus type 2 have been investigated repeatedly in scientific and clinical studies for more than 50 years. Investigations on perfused rat and mouse pancreas have shown glucose to induce pulsatile insulin and similar somatostatin secretion at about ten pulses per hour as well as phase-shifted pulsatile glucagon secretion. Insulin secretion pulsatility is considered to be a trigger mechanism in regulating hepatic gluconeogenesis and peripheral insulin receptor sensitivity. Some centres have therefore been using regular intravenous pulsatile insulin infusion therapy (PIT) in treating microcirculation disorders for more than 30 years. The literature includes positive anecdotal reports but only very few publications on scientifically conducted prospective and controlled clinical trials. Based on pathophysiological considerations, we developed an optimised PIT protocol (RESTORE) and used it to treat patients with type 2 diabetes and progressive complications on a weekly basis for three to six months. PIT showed positive changes in all patients, alongside measurable improvement in renal and nerval function, as shown by two patient cases. The patients also reported improved insulin action, decreased high blood pressure and an "energising" effect from the therapy. These encouraging results are now being reviewed and scientifically documented in a prospective pilot study.