Strelitz Diabetes Institutes Introduces
Innovative New Translational Treatment “ Intermittent Insulin Infusion Therapy” for Nerve Regeneration

Starting January 2006, the Strelitz Diabetes Institutes will open its innovative Intermittent Insulin Infusion clinical research program for both Type 1 and Type 2 diabetes patients with neuropathy.

Jointly sponsored by the Advanced Diabetes Treatment Centers of Florida, this new treatment will offer patients a new treatment for reducing symptoms, abrogating progression, and possibly reversing neuropathy. The program will also allow SDI clinical researchers to investigate factors that contribute to neurovascular dysfunction that are associated with neuropathy.

Previous studies with Insulin Infusion Therapy have shown that weekly intermittent intravenous infusion of insulin can reduce symptoms of dizziness and episodes of low blood pressure when changing position suggesting better nerve function, reduce high blood pressure, improve the ability to sense low blood sugar and delay the progression of diabetic kidney damage. It this has great promise for preventing and even reversing nerve damage.

According to Dr. Aaron I. Vinik, Director of Research, “The Neurovascular unit of the Strelitz Diabetes Institute is always seeking new and improved ways of translating important research findings into state-of-the-art therapies. We were very taken with the Van Den Bergh study in Belgium that showed that intravenous insulin administration to people in intensive care units prevented the development of severe neuropathy which is almost universally developed by people in that setting.”

“We are applying this approach to people with intractable neuropathy to see if we can achieve the same beneficial effects in people with diabetes and its neurologic complications. Anecdotally, there have been suggestions that this may work but, this will be the very first time that it is tested formally. We sought the collaboration of ADTC who have the wherewithal and techniques and equipment to make this feasible. We see this collaboration as a win, win, win situation where all parties including patients will score.”

The course of treatment takes a commitment of time – 6 hours, one day a week for one year. On the day of treatment, the patient sits leisurely in a comfortable chair watching television or reading while receiving intravenous insulin during three one-hour sessions. Body metabolism measurements are taken regularly, and between infusions, the patient is closely monitored to achieve desirable goals.

Laboratory blood tests are periodically conducted and patient well-being is evaluated during the course of treatment by quality of life assessments developed by the Strelitz Diabetes Institutes. In addition a complete evaluation that includes autonomic (involuntary) and somatic (voluntary) nerve function before and during the course of treatment to determine the impact of treatment is offered.

Intermittent Insulin Infusion Therapy has been approved by the Institutional Review Board of Eastern Virginia Medical School. You may qualify to be included in this study if you are:
* Between the ages of 18 and 70
* Have been diagnosed as having diabetic somatic or autonomic neuropathy
* Have been diagnosed with non alcoholic hepatic steatosis (NASH) syndrome, gastroparesis, or brittle diabetes
* Have any of the following symptoms compatible with neuropathy:
1. Anorexia, nausea, vomiting, dizziness upon standing, fullness or bloating after meals, erectile dysfunction or difficulties controlling bladder or bowel function
2. pain, numbness, tingling burning in the feet or hands,
3. weakness, such as tripping often, unsteadiness while walking or difficulty getting up from the sitting position.
* Someone with Type 1 or Type 2 diabetes
* Taking oral diabetic medication and/or insulin

Admission into the program begins with a thorough consultation with an endocrinologist at the Strelitz Diabetes Institutes.

Your health insurance company will be billed for some of the therapeutic procedures performed during this study. Some of the therapeutic procedures, conducted during the course of this study may not be covered by your insurance company because they are being done to examine the effect of an experimental treatment. We also cannot guarantee that insurance will cover the costs each time services are provided. Therefore, you will be responsible for the cost of any procedure not billed or not covered by your insurance company. This is likely to result in out-of-pocket expenses to you because of your participation in this study. Additionally, there will be co-pay, co-insurance, and deductible collected from you in association with all the procedures billed to insurance. Provided you satisfy the inclusion criteria, you are eligible to participate in this study regardless of the medical insurance coverage that you carry.

For more information, please e-mail Dr. Jorge Jacot at jacotjl@evms.edu