ФГБУ «ВНИИИМТ» Росздравнадзора – национальный испытательный институт России.

Scientists have been in search for new approaches of treating diabetes since 1980-ies.

2.              Donor pancreas transplantation 

3.              Transplantation of Beta cells from the donor pancrease

The project of transplanting beta cells and pancreas has not yet been put into practice, because of the general problem of tissue incompatibility. The creation of an artificial pancreas is still under development.

All these approaches as well as the substituting insulin therapy can be refered to the so-called insulin "prosthesis" therapies. Today there is a crave for inventing a therapy to restore and increase the islets of Langerhans beta cells' production of insulin and thus to completely abandon the insulin injection therapy or significantly reduce the doses of insuline injections.

This can be achieved through profound understanding of the etiology and pathogenesis of type 1 diabetes. Scientific literature, published before 20.05.1982, contains little information on the subject.

It was known that diabetes was caused by genetic weakness of islets of Langerhans beta cells and pancreas overpress as a result of a stress, intoxication or overeating.

However, this theory contradicted the well-known fact, that diabetes frequently follows a contagious disease.

Moreover, there was no positive explanation of the cause of sporadic remissions of contagious diseases during the first stages of type 1 diabetes, which create the illusion of recovery.

The research, published in 1982, showed that the main reason of insulin deficit in Type 1 diabetes was local virus-caused chronic inflammatory damage of islets of Langerhans. It can be alleviated by using full insulin compensation and diet 9 in combination with resolvent immunosuppresive therapy, which increases and even completely recovers the insuline-producing function of B-cells and significantly reduces or completely abandons the need to use insuline injections.

The method is clinically tested and patented.

Patent #2000782. Priority date 20.05.1982. Registration date 15.10.1993.

"Treatment of Type 1 diabetes at early stages".

Summary of invention.

Apart from insulin injections and diet, the Type 1 diabetes therapy

includes use of resolvents, which in addition to the full insuline

compensation, can reduce the period of treatment by recovering the

insulin producing function.

Author's certificate #1152595. Priority date 25.08.1982. "Treatment of Type 1 diabetes at early stages".

Summary of invention.

The Type 1 diabetes therapy at early stages includes insulin injections

and diet. In order to reduce the duraton of treatment and prevent insulin

resistence, 15-20 minute sodium salicylate electrophoresis (8-15 µA) of

the pancreas is additionally applied.

The following technical solution to the problem of treating Type 1

diabetes at early stages is offered: "Method of recovering the insulin

producing function of the pancreas of young newly sick patients".

Priority date 28.06.1984. Patent application # 3756387/13(084723).

Summary of application for invention:

   - Method of recovering the insulin-producing function of the pancreas of young newly-sick patients includes full insulin compensation, diet 9 and hydrocortison phonophoresis of the pancreas.

The application was not approved. The reason - hydrocortison is an antagonist to insulin. The experts did not understand how it could alleviate inflammation in the islets of Langerhans. Only in 1987 there was published a scientific report, which partially covers the essence of our application (A. Secchi, "Medicine Journal", section 20, October, 1987, article 1271). Using prednisolone along with insulin compensation A. Secchi achieved remission of the disease, which allowed him to abandon insuline injections, keeping the compensation.

The two-stage type 1 diabetes therapy tests showed that the best effect was achieved when the history of the disease did not exceed 12 months. It was possible then to relieve the disease as well as abandon insuline injectons and use only diet 9 for compensation. The test group consisted of 25 patients at the very first stage of diabetes, 12 with the disease history up to 12 months and 13 patients with 2-5 years' history. In the aftermath of the therapy it is not possible to abandon the insulin therapy completely, keeping the compensation by using only diet 9. With the 1-2 years' history of diabetes the insulin therapy can be reduced by two thirds; with 2-3 years' - no more than by one third, which shows steady development of irreversible changes in the beta cells insuline producing function. Only two patients with more than 3 years' diabetes history showed signs of improvement (period of observation 1-2 months). In the aftermath of the 2-stage therapy the insuline dose for a patient with the 8-year diabetes has been reduced from 80 to 12 units, keeping the compensation.

Our research has proved that the recurrence of the disease after the successful 2-stage therapy of the early Type 1 diabetes may require repetition of the therapy, which includes diet 9, full insuline compensation and additional resolvent therapy in order to achieve the new remission of the disease by using diet 9 only without insulin injections.

In the course of the above-mentioned studies we have discovered a completely new pattern: resolvent therapy can alleviate inflammations in the beta cells and restore Beta cells' production of insulin only if used along with full insulin compensation.

Early type 1 diabetes is the so-called "testing ground", combining the focus of inflammation (in the islets of Langhergans) and insuline defficiency, which allowed us to make a brand new pattern - resolvent therapy does not produce any effect in insuline defficiency, while used along with insuline compensation it produces anti-inflammatory effect, removing the focus of inflammation in the islets of Langhergans, which is proved by the recovery of beta cells and producton of insuline). This new pattern has a great significance in internal diseases therapy and was materialized in the following invention: patent # 210400 "Method of treating inflammation", priority date 30.06.1994.

It is worth saying that a number of early Type 1 patients has a labile form of the disease, which encumbers full compensation by the insuline therapy and diet. In such cases the resolvent therapy does not produce any effect. In our opinion, the ethiology and pathogenesis of this form of the disease are influenced by some unclear factors apart from the chronic viral inflammation of the islets of Langhergans. These factors may include Protozoa, fungi and helminthiasis. Positive effect can be achieved by taking these factors into account during the treatment.

The offered 2-stage non-steroid resolvent therapy for type 1 diabetes has been tested in 16 Russian medical institutions on 221 patients. The age varied from 5 to 40 years with the highest disease history of 5 years.

Positive results were achieved in 181 cases (82 pet.), the rest 40 patients (18 pet.) showed no signs of improvement. In the aftermath of the therapy 20 patients abandoned insulin injections, but kept diet and compensation, 12 patients were able to abandon the insuline therapy and were put on adebitis and manilin diet. In 96 cases the insulin dose was reduced by 60-90 pet and in 53 - by 30 pet.

A number of Russian and foreign research that were published after the priority date have proved our conclusions.

1.  Some virus (for example, rubella, epidemic parotitis, Coxsakie B4 virus) can cause destruction of genetically weak beta cells of the pancreatic islets. At the early stage of diabetes (up to 1 year), many patients show changes in the pancreatic islets, such as infiltration of the islets by mononuclear cells, mainly lymphocytes, and histocytes along with polymorphous leukocytes, which is followed by degranulation of beta cells. (V.Potemkine «Endocrinology@», 1986, p.219, A. Mazovetsky, V. Velikov "Diabetes, 1987, p.24, M. Balabolkine "Endocrinology", 1998, pp. 392-395). 

2.              Foreign researchers have been actively and succesfully developing a beta cells recovery therapy, using cyclosporine immunosuppressive, but the marked nephrotoxicity of the therapeutic has made scientists look for an appropriate non-toxic analogue. In 1987 Secchi has achieved positive effect using prednisolone after diet 9 and insulin compensation, (materials of the first European Endocrinologists Convention, Copenhagen, 21- 25.06 1987, (A.Secchi, England).

The drawback of these technical solutions of treating type 1 diabetes is long-term use of drugs, that puts additional chemical pressure on a patient's body.

The research has led to the following conclusion.

A new pattern of ethiology and pathogenesis of type 1 diabetes has been discovered. At the first stage of the diabetes (12 months since discovery of the disease) a chronic viral inflammation of the islets of Langhergans of masked and frequently reversible character appears, which leads to degenerative changes in Beta cells and further to the destruction of the insulin production. Priority date 20.05.1982.

We have designed a device, which can remove the inflammatory edema and virus in beta cells of the islets of Langhergans, eliminate chronic inflammation, caused by virus infection and microbes, flora, fungi, Protozoa and helminthiasis, recover beta cells insulin production, by long and profound warming of pancreas, liver, spleen, lumbar region as well as vertebral column (from loin to the fourth cervical vertebra) and the thoracic lymaptic duct region. The device is worn at the belt, functiones manually and automatically and is equipped with self-contained power supply and temperature control unit.

The belt is designed for long-term wearing. It is worn daily for 12 hours with a 1-2 hours break for the period ranging from 3 months to 1-3 years. The dose of insulin injections is prescribed in accordance with sugar level in blood and urine. Best used in the first year of the disease. Copyright. Priority year 2001.

The summary.

Type 1 diabetes

Etiology and pathogenesis.

Insuline-producing beta cells recovery therapy

By B.Bleskin MD, member of the Russian Academy of Medical and Technical Sciences and the Russian Academy of Natural Sciences, Professor O.Mashkov MD, member of the Russian Academy of Medical and Technical Sciences and the Russian Academy of Natural Sciences, A.Matorin, E.Novikov, L.Ryzhonkina and A.Kolnauz.

A new pattern of ethiology and pathogenesis of type 1 diabetes is discovered. A device for removing inflammation edema and virus activity in beta cells of the islets of Langergans is designed.