CLINICAL STUDY REPORT
Usage of "Neo-Inulin"

MEDICAL TECHNOLOGY "NEO-INULIN" FOR THE TREATMENT OF TYPE 2 DIABETES MELLITUS

Abbreviated Version

Developer:
Federal State Budgetary Scientific Institution "East Siberian Institute of Medical and Ecological Research"

Authors:
  • Katamanova E.V. – Chief Physician of the FGBNU VSIMEI Clinic, MD, Associate Professor
  • Beigel E.A. – Deputy Chief Physician for Medical Affairs of the FGBNU VSIMEI, Associate Professor of the Department of Occupational Pathology and Hygiene at IGMAPO – Branch of FSBEI DPO RMANPO of the Ministry of Health of Russia, PhD
  • Kuptsova N.G. – Functional Diagnostics Physician at FGBNU VSIMEI

Abstract
The presented medical technology is a method of treating type 2 diabetes mellitus, expanding the arsenal of means for normalizing glycemia, improving blood lipid profile, restoring the endothelium, and normalizing microcirculation. One such means is the drug "Neo-Inulin". This medical technology is intended for endocrinologists, therapists, general practitioners in medical institutions and medical health centers, as well as for scientific researchers.

Description of the Sections of the Medical Technology
  • Introduction
  • Indications and Contraindications for the Use of the New Medical Technology
  • Material and Technical Support for the New Medical Technology
  • Description of the Medical Technology
  • Possible Complications and Their Management
  • Effectiveness of Using the Medical Technology
  • Expected Effect of Implementation
  • References
  • Appendix
  • List of Abbreviations and Symbols

Introduction
The medical technology "Method of Integral Assessment of the Dynamics of Metabolic Disorders in Patients with Type 2 Diabetes Mellitus during Therapy with the Dietary Supplement 'Neo-Inulin'" is new and is being proposed for the first time in the Russian Federation. According to WHO data for 2018, 425 million people worldwide are registered with diabetes mellitus. With increasing life expectancy, the number of such patients is growing. Among all causes of hyperglycemia, type 2 diabetes mellitus takes the leading position. The incidence of this type of diabetes is catastrophically increasing in all countries and doubles every 15-20 years.

Indications for the Use of Medical Technology
The method is used to assess metabolic disorders in diabetes mellitus and expand the possibilities of treating type 2 diabetes mellitus. The developed treatment method can be used in outpatient and inpatient settings for personalized therapy.

Contraindications for the Use of Medical Technology
  • Pregnancy and lactation period
  • Decompensation of cerebrovascular diseases, cardiovascular diseases, malignant tumors, kidney diseases, liver diseases, thyroid diseases, active tuberculosis, or other infectious diseases
  • Drug or alcohol dependence
  • Systemic steroid or immunosuppressive therapy
  • Sensitization and hypersensitivity to dietary supplement components

Material and Technical Support
The studies were conducted with the informed consent of patients and complied with the ethical norms of the Helsinki Declaration (2000) and the Order of the Ministry of Health of the Russian Federation No. 266 (19.06.2003). For the study, the following are necessary:
  • Disposable vacuum system tubes for venous blood collection
  • "LACC-01" device for assessing blood microcirculation

Description of the Medical Technology
The diagnosis of diabetes mellitus is established based on laboratory indicators. The study involved patients who underwent biochemical blood tests and other diagnostic procedures. Laser Doppler flowmetry (LDF) was used to assess blood microcirculation.

Effectiveness of Using the Medical Technology
After the end of a two-month course of therapy with the dietary supplement "Neo-Inulin," all patients in the third group transitioned to the first and second groups with less pronounced disorders. Positive dynamics were noted in glycated hemoglobin, fasting glucose, kidney function (creatinine and GFR), and microcirculation indicators.

Expected Effect of Implementation
The method allows for an objective assessment of the effectiveness of "Neo-Inulin" in addition to basic diabetes therapy and enables the personalization of therapeutic measures aimed at maintaining health and longevity. The treatment regimen including "Neo-Inulin" contributes to improving quality of life, psychosocial adaptation, and treatment effectiveness for patients with diabetes mellitus.

Conclusion
To enhance the effectiveness of rehabilitation for patients with diabetes mellitus, it is recommended to prescribe "Neo-Inulin" at 1 capsule in the morning and evening with meals for 3 months. To consolidate the result, it is recommended to repeat "Neo-Inulin" courses 3 times a year for 2 months each.