Effect Pulsatile IV Insulin Therapy on the Quality of Life in Patients With Types 1 and 2 Diabetes
Effect Pulsatile IV Insulin Therapy on the Quality of Life in Patients With Types 1 and 2 Diabetes
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 44
 item questionnaire is completed prior to the start of the treatment and quarterly thereafter
 with detailed analysis performed to measure progress and outcomes.
It is known that the glucose metabolic pathway (glycolysis) is the primary fuel generator in
 the brain and nerve tissue, the heart and vascular tissue, the eye, the kidney and the liver
 Deficient metabolic states such as seen in the glucose metabolism of diabetics can lead to
 sequelae. These damaging effects are exacerbated by altered cellular metabolites,
 specifically the increase in catabolic and decrease in anabolic factors. It has been shown
 over the past twenty years that normalization of metabolism in diabetic patients can be
 accomplished by mimicking the normal endogenous insulin pattern (ie., in pulses). Pulsatile
 insulin infusion has been demonstrated to reverse the diabetic metabolic state from primary
 fat utilization to carbohydrate utilization. This has been correlated with a stabilization of
 kidney function in patients with overt diabetic nephropathy, stabilization of blood glucoses,
 stabilization of blood pressure patterns, and reversal of hypoglycemic unawareness.

 The Diabetes Impact Measurement Scale was originally developed to assess quality of life in
 patients with types 1 and 2 Diabetes Mellitus. This study measures whether the reversal of
 abnormal metabolism in patients with diabetes is correlated with an improvement in their
 quality of life.The respiratory quotient (RQ) is a measurement of CO2 exhaled and O2 inhaled
 and is proportionate to the fuel sources being used by the body, primarily the liver over
 short periods of time. The higher the RQ, the more glucose and less alternative fuel sources
 are being utilized. Following the RQ change helps determine the effectiveness of
 physiological insulin administration in increasing anabolic functions in diabetic
 individuals. By improving the body's glucose metabolism and thereby causing beneficial
 effects of anabolic factors, the possibility of serious complications can be decreased. In
 addition the use of oral carbohydrate at the same time along with the physiologic insulin
 administration stimulates the appropriate gut hormones which augment this effect, a response
 which cannot be duplicated with intravenous glucose. The purpose of our studies is to
 determine whether the physiologic administration of insulin along with the augmenting effect
 of oral carbohydrates will normalize metabolism in diabetic patients and improve their
 quality of life indices.

 The RQ is determined by the use of a metabolic cart. Individuals breathe into a mask for 3-5
 minutes after a rest period of 30 or more minutes. The ratio of exhaled volume of CO2 to the
 inhaled volume of O2 is determined as the RQ. The physiologic range is 0.7 to1.3. Individuals
 using fat as a primary fuel have a ratio of 0.7, protein or mixed fuels is 0.8-0.9 and
 carbohydrate is 0.9-1.0. Those taking excessive calories will have RQ's higher than 1.05. The
 RQ can be followed serially and this is done before and after each pulsatile IV insulin
 treatment, during the 3 successive sessions on a single treatment day. The amount of
 intravenous insulin and oral glucose given is determined by the RQ changes during the
 previous session.pulsatile IV insulin therapy encourages the glucose metabolism in diabetics
 to normalize in multiple organs, especially muscle, retina, liver, kidney and nerve endings.
 The process fundamentally requires the administration of high dose insulin pulses similar to
 those found in non diabetic humans by their pancreas into the surrounding portal circulation.
 Oral carbohydrates are given simultaneously to augment the process and prevent hypoglycemia.
 The process is monitored by frequent glucose levels and respiratory quotients (RQ). RQ is
 measured by a metabolic cart which determines the ratio VCO2/ VO2. This ratio is specific for
 the fuel used at any one time by the body. The glucose levels are monitored to keep glucose
 levels appropriate and the RQ determines the need to readjust the infusion protocol in each
 patient for subsequent insulin infusion sessions.Patient is evaluated post session and
 discharged when stable.

 Frequent monitoring of RQ is necessary as these levels change rapidly, depending on the fuel
 being utilized by the body. Pulsatile IV insulin therapy shifts metabolism from primarily
 fatty acid metabolism to primarily glucose metabolism. This shift is reflected by the
 increase in respiratory quotient. However during rest periods the RQ may fall back to lower
 levels. Therefore RQ's are done at the beginning and at the end of each insulin infusion
 session of 1 hour in order to appropriately monitor and adjust insulin and carbohydrate loads
 to reach optimal activation in each session.
Inclusion Criteria:

 -  The researchers will include up to 200 patients both male and female between the ages
 of 21 and 85 diagnosed with type 1 or type 2 diabetes mellitus.

 -  Self reporting or diagnosed with significant complications resulting from diabetes

 -  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

 -  Inability to respond to 44 item questionnaire

 -  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