REPORT ON THE CLINICAL STUDY OF THE EFFECTIVENESS OF "NEO-INULIN" IN THE COMPREHENSIVE TREATMENT OF PATIENTS WITH TYPE 2 DIABETES MELLITUS

Abbreviated Version

Lead Clinical Investigator: Chief Physician of the FGBNU VSIMEI Clinic, Neurologist, MD, Associate Professor E.V. Katamanova
Lead Executive – Research Coordinator: Head of KDL, MD, Associate Professor I.V. Kudaeva
Lead Executive – Research Coordinator: Deputy Chief Physician for KER, PhD O.V. Ushakova

Introduction Diabetes mellitus (DM) is one of the most serious medical, social, and economic healthcare problems worldwide. The incidence of DM doubles every 10-15 years, taking on the character of a non-infectious epidemic. According to WHO, there are currently 230-347 million people with DM worldwide, and by 2025 this number is expected to reach 380 million, and 435 million by 2030. The real growth rates of incidence significantly outpace even these discouraging forecasts. The greatest danger of this disease is associated with the development of vascular complications. The modern level of diagnostic tools, advanced glycemic monitoring means, introduction of innovative insulins and glucose-lowering drugs, and the development of high-tech treatment methods can significantly change the prognosis for patients, reducing the frequency of development, disability, and mortality due to chronic complications of DM. Maintaining target control of risk factors: glycemia, hypertension, and dyslipidemia from the onset of DM throughout the patient's life remains the most promising direction for preventing the development and progression of diabetic complications.
Type 2 diabetes mellitus (T2DM) is a chronic disease characterized by both insulin resistance and impaired insulin secretion. Among all causes of hyperglycemia, T2DM occupies a leading position, and the incidence of T2DM is catastrophically increasing in all countries without exception, doubling every 15-20 years. Chronic hyperglycemia is not the only component of T2DM. Increased glucose is accompanied by visceral obesity, arterial hypertension (AH), elevated low-density lipoproteins, triglycerides, and reduced high-density lipoproteins. Most patients also exhibit impaired fibrinolytic properties of blood, increased uric acid levels, and non-alcoholic fatty liver disease (NAFLD). Thus, when determining the treatment strategy for T2DM, associated hyperglycemia disorders or their clinical outcomes should be taken into account.
The main complication of DM is microangiopathy, endothelial damage due to excessive levels of glycated blood proteins. The primary function of the endothelium is to maintain a balance between opposing processes of vasodilation and vasoconstriction, pro- and anti-inflammatory, pro- and antithrombotic, pro- and antioxidant reactions, suppression and stimulation of proliferative processes, as well as regulation of vascular permeability, leukocyte adhesion, platelet-vascular interactions, and participation in vascular remodeling. The endothelium plays a key role in controlling vascular tone, regulating vessel lumen depending on blood flow rate and pressure on the vessel wall, and the metabolic needs of the tissue.
Therefore, the search for new medicinal products that normalize glycemia, improve blood lipid profile, restore the endothelium, and normalize microcirculation is extremely relevant. One such product is "Neo-Inulin", containing inulin, dihydroquercetin, lipoic acid, chromium, and bilberry shoot extract, which exhibits hypoglycemic, antioxidant, hepatoprotective effects, stimulates tissue blood flow, stabilizes microvessel barrier function, reduces capillary wall permeability, thereby reducing congestion in the microcirculatory bed and restoring the endothelium.

Objective of the Study The objective of the study was to evaluate changes in patients with diabetes mellitus using clinical questionnaires, biochemical blood indicators, electrocardiographic data, ABI, and fluorimetry during treatment with "Neo-Inulin".

Methodology and Study Design The study included 17 women (mean age – 64.5±8.7 years, mean weight – 77.8±11.4 kg) and 3 men (mean age – 54.6±12.4 years, mean weight – 114±40.2 kg) with type 2 diabetes mellitus. The average disease duration was 11.0 (7.0–12.0) years. "Neo-Inulin" was administered at a dosage of 2 capsules per day for 12 weeks, in addition to the basic diabetes therapy. Upon admission to the clinic, patients with DM underwent questionnaires, medical history collection, study of DM risk factors, ECG, complete blood count, urinalysis, laser fluorimetry, ABI determination, biochemical blood tests including levels of creatinine, glycated hemoglobin, MAU, GFR, and glucose. Patients were examined by a therapist and an endocrinologist.

Study Results During the administration of "Neo-Inulin", there was a statistically significant reduction in glucose, glycated hemoglobin, MAU, and indicators characterizing limb vessel microcirculation. Before treatment, patients had reduced quality of life scores across all scales, indicating the negative impact of physical condition on daily duties, presence of pain, emotional problems, fatigue, and reduced work capacity. After treatment with "Neo-Inulin", there was a significant improvement in quality of life scores across all scales, including physical and mental components. The overall satisfaction index was 1.3±0.1 points, indicating a high level of satisfaction. Social frustration was noted in 88% of patients before treatment and 6% after treatment, indicating significant improvement in social functioning. The target level of glycated hemoglobin was achieved in 12 out of 21 patients. Normal blood glucose levels were recorded in 33.3% of patients after treatment. Creatinine and GFR levels also improved in a significant portion of patients.

Conclusions The treatment regimen including "Neo-Inulin" contributed to improved quality of life scores, better psychosocial adaptation, treatment effectiveness, and overall life quality. Positive dynamics were observed in MAU, glycated hemoglobin, and fasting glucose indicators. Treatment with "Neo-Inulin" in comprehensive therapy for type 2 diabetes mellitus normalized some complete blood count parameters, microcirculation, and increased hemoglobin levels.

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