AIM: Formation of a system of target indicators for rating and integral assessment of the effectiveness and efficiency of the organization of medical care for patients with diabetes mellitus in the Russian Federation regions.

MATERIALS AND METHODS: The study was an expert survey in the form of a structured interview. At the first stage, we performed the primary selection of indicators. At the second stage, the selection of experts took place in accordance with the inclusion criteria, and the assessment of the level of expert competence was assessed based on a self-assessment survey. Further, criteria we formulated for expert evaluation of the significance of the selected indicators in accordance with the principles used in the development of national and federal projects. The indicators were divided into two groups: additional (process) and main (outcome). To quantify the degree of agreement between the experts’ answers, Kendall’s concordance coefficient (W) was calculated. The significance of differences was assessed using the nonparametric Friedman test.

RESULTS: Only indicators with a high degree of agreement between experts and the presence of statistical significance in terms of the concordance coefficient are recommended as target indicators. The following main and additional indicators satisfy these requirements: mortality from cardiovascular complications of type 2 diabetes (people per 100,000 population); the proportion of patients with type 1 and 2 diabetes mellitus provided with medical devices out of the total number of patients with type 1 and 2 diabetes mellitus (percentage); the proportion of patients with type 1 and 2 diabetes mellitus with high amputations of all patients with type 1 and 2 diabetes mellitus with any amputations (percentage); and other indicators.

CONCLUSION: We selected indicators that can be used both for the integral rating of the constituent entities of the Russian Federation, and in the formation of federal projects or departmental target programs. The results of the study can also be used to organize a system for monitoring the effectiveness of the implementation of these projects and programs.

BACKGROUND: The World Health Organization considers diabetes mellitus as a significant public health problem, including this disease as one of the four priority noncommunicable diseases. Over the past few decades, the prevalence of diabetes has been steadily increasing and represents a significant threat to the public health of the world’s population. In connection with the territorial features of residence and the availability of medical care to residents of urban and rural areas, studies that include an analysis of the incidence of diabetes mellitus, disability and mortality of the urban and rural population from complications of this disease are one of the important mechanisms for monitoring the health status of the population, which predetermines the improvement and implementation strategies aimed at improving the demographic situation.

AIM: To conduct a comparative retrospective analysis of the health indicators of patients with type 1 and type 2 diabetes mellitus living in urban and rural areas of the Saratov region.

MATERIALS AND METHODS: Information on life expectancy, morbidity, complications, causes of disability, direct causes of death in patients with type 1 and type 2 diabetes mellitus living in the Saratov region in urban and rural areas was obtained from the Federal Register of Patients with Diabetes; information on the urban and rural population of the Saratov region was obtained from official statistical sources published on the website of the Federal State Statistics Service. Mathematical, statistical and analytical research methods were used. Statistical data processing was carried out using the Microsoft Excel 2019 program. The significance of the difference between the average and relative values was assessed using the Student’s t-test. The presence of a relationship between the signs was determined using the Pearson coefficient. The Mann-Whitney U-test was used to compare populations by quantitative characteristics. The significance level was determined at t>2 and p<005. Data were presented as P ± m, where P is the relative value and m is its standard error, and M ± m, where M is the mean value and m is its standard error.

RESULTS: A higher average life expectancy was noted for people with type 2 diabetes, regardless of place of residence, in comparison with the same indicator in the Saratov region. The average life expectancy of patients with type 1 diabetes is 18 years lower than in the Saratov region for those living in urban areas and 17 years for rural residents. There is an excess of the levels of primary and general morbidity in people suffering from type 1 and 2 diabetes and living in rural areas over the same indicators of urban residents. The main causes of death in both urban and rural patients with type 1 and 2 diabetes are: chronic cardiovascular insufficiency, cerebrovascular accident and acute cardiovascular diseases. Disability rates in patients with type 2 diabetes living in urban areas are lower than in rural areas.

CONCLUSION: Analysis of data from the Federal Register of Patients with Diabetes Mellitus in the Saratov Region showed high levels of primary and general morbidity, disability and mortality in patients with type 1 and 2 diabetes living in rural areas. Also, frequently occurring complications from the cardiovascular system were identified in all patients with type 1 and type 2 diabetes, regardless of the place of residence. The relationship between the levels of morbidity, mortality, disability, the incidence of complications and the place of residence of patients with type 1 and type 2 diabetes is not statistically significant.

BACKGROUND. The COVID-19 pandemic has caused enormous damage to all countries of the world. Patients with diabetes mellitus are a separate risk group for the consequences of COVID-19, both in the acute and in the long-term period.

AIM. To study change in the structure of mortality among patients with diabetes in the Republic of Uzbekistan during the COVID-19 pandemic.

MATERIALS AND METHODS. We analyzed the data of the report forms of endocrinological dispensaries for reasons of deaths registered among patients with 2 diabetes mellitus in 2020 and compared these indicators with the data of 2019.

RESULTS. In 2020, mortality among patients with diabetes increased 1.5 times compared to 2019 and was 4.3% (compared to 2.8% in 2019). Among the causes of deaths, cardiovascular accidents prevailed: 57,9% in 2020 (48,0% in 2019), cerebrovascular accidents (15,6% in 2020 and 24,2% in 2019), chronic kidney disease (12,0% and 15,1%), gangrene, sepsis (1,2% and 1,8%), the frequency of hyper- and hypoglycemic comas as causes of death was 0.6% both in 2019 and in 2020, however, the absolute number increased in 2020. Among the «other» causes of death (12.8% in 2020 and 10,2% in 2019), COVID-19 itself was 52,3%, pneumonia 17,2%, pulmonary embolism 1%, oncological diseases 12%, liver cirrhosis 12%.

CONCLUSIONS. Despite the fact that COVID-19 caused deaths in 6.7% of patients with diabetes, the COVID-19 pandemic caused a significant increase in mortality — 1.5 times — among patients with diabetes, mainly due to acute cardiovascular accidents, stroke, as well as accelerating the progression of chronic complications of diabetes, in particular chronic kidney disease.

BACKGROUND: Psychological predictors of overall mortality in the Russian population of Type 2 diabetic patients and their impact compared to biological risk factors have not been studied.

AIM. To identify clinical, laboratory and psychological factors independently associated with the 5-year overall mortality in Type 2 diabetic patients in the Moscow region.

MATERIALS AND METHODS: This open label observational prospective study included 178 consecutive type 2 diabetic patients (women 145, men 33, age range 37 to 82 years, duration of diabetes 0,5 to 30 years). At baseline, in addition to the standard clinical, laboratory and instrumental work-up, all patients were assessed for depression, cognitive dysfunction and diabetes-related quality of life. No study-related intervention was performed; all patients were followed up and treated by their local physicians. After 5 years, we assessed the patients’ vital status (alive or dead). Multiple logistic regression was used to identify baseline patients’ characteristics, which were significantly and independently associated with 5-year overall mortality. Taking into account the exploratory type of multiple regression, the results were considered significant at α<0.1.

RESULTS: At 5 years, 150 (84%) patients were alive and 15 (8,4%) were dead; no information could be obtained for the rest 13 (7,3%) patients. The analysis of 165 patients with the verified outcome, independent and significant associations with the death outcome were found for male gender (odds ratio [OR] 6,36 [95%CI 0,91–44.40]; p=0.06), age (OR 2.06 [1.30–3.27]; p<0.002), chronic heart failure (CHF) (OR 2.78 [1.25–6.2]; р=0.012), Hamilton depression scale score (OR 1,18 [1.03–1.34]; р=0.016), cognitive dysfunction score (Roschina scale) (OR 1.20 [1.05–1.35]; р=0.006), and age — body mass index interaction (OR 0,98 [0,97–0,997]; р = 0,013). The predicted probability of death within the next 5 years in men and women was 22,9% and 6,7%, respectively. The highest score of cognitive dysfunction was associated with a 25% predicted probability of death and the lowest, with a 2% probability of death; predicted probabilities of death for the highest and lowest depression scores were 26% and 2%, respectively. The 5-year predicted probability of death in the patients without CHF was 6,7%, with CHF I NYHA functional class, 9,8%, II functional class 13,6%, III functional class 18,2%, and IV functional class 23,5%. All other baseline clinical, laboratory, demographic, psychological and socioeconomic variables were not significantly associated with the 5-year survival rate. The model was not verified on an external cohort.

CONCLUSION: Cognitive dysfunction and depression have a significant negative impact on the 5-year mortality rate at much higher degree, than glycemic control, any diabetes-related complications and cardiovascular disorders, excluding CHF. The results obtained highlight the importance of the diagnosis and treatment of depression and cognitive dysfunction in type 2 diabetes mellitus.

BACKGROUND: Male hypogonadism is associated with type 2 diabetes mellitus (T2DM), therefore, it is of interest to study its frequency. The clinical symptoms of hypogonadism are not specific, and laboratory diagnostics is the basis for its detection. The optimal method for this diagnostics is isotope dilution liquid chromatography/tandem mass spectrometry, which was used in our study.

 AIMS: Assessment of the incidence and aggravating factors of male hypogonadism in type 2 diabetes

MATERIALS AND METHODS: A full-design, cross-sectional, screening, single-center, non-interventional study included men with T2DM, who were he was treated in Endocrinology Research Centre, Moscow. The study was conducted from October 2021 to January 2022. Medical history assessment, physical examination with determination of body mass index (BMI), measurement estimation of total testosterone by isotope dilution liquid chromatography/tandem mass spectrometry, glycated hemoglobin (HbA1c) and lipid profiles were performed. The groups were compared using the Mann-Whitney U-test for quantitative indicators and χ² with Yates’ correction for qualitative ones. Differences were considered statistically significant with p0,05.

RESULTS: Hypogonadism was detected in 355 (70.3%) men with T2DM. Patients with hypogonadism had statistically significantly higher BMI, worse glycemic control, lower HDL levels, and higher triglycerides than eugonadal men. An additional comparative analysis among non-obese individuals showed the presence of statistically significant differences in the level of HbA1c (higher in hypogonadal men) and HDL (lower in hypogonadal men). An analysis of hypogonadal patients depending on the presence of obesity showed statistically significant differences between groups in the level of total testosterone (lower in obese men) and triglycerides (higher in obese men).

CONCLUSIONS: The prevalence of male hypogonadism in type 2 diabetes was 70,3%. Its development was associated with obesity and poor glycemic control.

BACKGROUND: High glucose variability (GV) is recognized as a risk factor for vascular diabetic complications and hypoglycemia. Factors affecting GV in patients with diabetes needed to be clarified.

AIM: To determine the factors associated with high GV in adult patients with type 1 diabetes.

MATERIALS AND METHODS: We conducted a single center cross-sectional observational study. In-patients with type 1 diabetes aged 18 to 65 years on basal bolus insulin therapy were included. Day-time and nocturnal Coefficient of Variation (CV), Mean Amplitude of Glycemic Excursions (MAGE), Mean Absolute Glucose (MAG) were calculated from continuous glucose monitoring data. The values of CV, MAGE, MAG within the upper quartile were considered high.

RESULTS: The study included 400 individuals, including 111 on continuous subcutaneous insulin infusion (CSII). Patients with high GV had lower fasting and postprandial C-peptide levels and higher insulin doses. According to ROC analysis, daily insulin dose >0.69 U/kg and estimated glomerular filtration rate (eGFR) ≥90.5 ml/min×1.73 m² were associated with high nocturnal CV values. Dose of basal insulin >0.292 U/kg and bolus insulin >0.325 U/day were associated with nocturnal MAGE. Body mass index (BMI) ≤23.2 kg/m², waist circumference ≤80.5 cm, daily insulin dose ≥0.69 U/kg, HbA1c ≥8.3%, eGFR ≥89.5 ml/ min×1.73m² increased risk of high MAG at night. High day-time CV values were associated with daily insulin dose ≥0.675 U/kg and daily dose of BI ≥0.286 U/kg. The risk of high MAGE was increased with HbA1c ≥8.24% and basal insulin dose ≥0.286 U/kg. BMI ≤23.2 kg/m², waist circumference ≤80.5 cm, daily insulin dose ≥0.69 U/kg, daily dose of bolus and basal insulin ≥0.325 and ≥0.29 U/kg respectively, and HbA1c ≥8.33% were the risk factors for high day-time MAG. Patients on CSII had lower MAGE (p<0.001) and MAG (p=0.008) compared to those on multiple daily injections.

CONCLUSION: In type 1 diabetes, high GV is associated with undetectable residual insulin secretion, normal or reduced body weight, preserved kidney function, supraphysiological doses of insulin, and non-target HbA1c. Patients on CSII have a lower GV than those on multiple daily injections. 

BACKGROUND: Biliopancreatic diversion (BPD), and its modifications, is the most effective surgical bariatric treatment of morbid obesity and associated metabolic disturbances. However, at present comparative studies of the dynamics of carbohydrate metabolism after various modifications of the BPD are lacking.

AIM: comparative assessment for the effectiveness of biliopancreatic diversion with duodenal switch (BPD-DS) in the HessMarceau and single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) modifications for correcting carbohydrate metabolism disorders and achieving remission of Diabetes mellitus type 2 (DM2) within a period of up to five years after both operations.

MATERIALS AND METHODS: within the framework of a prospective study, 200 patients with morbid obesity were operated on using the BPD-DS (group 1, n = 100) and SADI (group 2, n = 100) methods, the dynamics of clinical and laboratory parameters was analyzed in groups depending on the presence, or absence, of DM2, with an emphasis on the analysis of indicators of carbohydrate metabolism. DM2 was diagnosed in 35 (35.0%) patients in group 1 (BPD - DS) and 45 (45.0%) in group 2 (SADI). All patients underwent a standard set of clinical, laboratory and instrumental examination methods before, immediately after and at 3, 6, 9, 12, 18, 24, 36, 48 and 60 months after the operation.

RESULTS: 5 years after the operation, complete remission of DM2 was achieved in 38 (84.4%) and 32 (91.4%) patients from the SADI and BPD-DS groups, respectively, and 7 (15.6%) and 3 (8.6 %) of patients achieved partial remission. The level of C-peptide, which also decreased after both modifications of BPS, was higher in patients after BPS in the SADI modification, both in patients with DM2 36 months (p<0.05), and in patients without DM2 at 3, 12 and 24 months after surgery (p<0.05).

CONCLUSION: The frequency of achieving stable remission of DM2 is comparable in both groups. The carbohydrate profile of patients after SADI is characterized by higher levels of glucose and C-peptide compared to BPD-DS at different periods of follow-up over five years.

BACKGROUND: Osteomyelitis in diabetic osteoarthropathy occurs in 65 % of cases, and it is the main cause of non-traumatic amputations. The choice of optimal treatment technologies should be based on understanding the pathogenetic characteristics of this disease.

AIM: To study the pathomorphological and pathochemical picture of osteomyelitic focus in patients with diabetic neuroosteoarthropathy.

MATERIALS AND METHODS: Object — 20 patients (55.3±9.33 years) with Type 2 diabetes mellitus, diabetic neuroosteoarthropathy, chronic osteomyelitis of the foot bones. The treatment consisted in surgical debridement of the purulent focus with the material collection for pathomorphological and biochemical studies, and in reposition and alignment of bone fragments with the leg and foot fixation using the Ilizarov fixator in order to form bone ankylosis of the compromised joint.

RESULTS: Subacute and acute course of chronic osteomyelitis was registered in 80 % of cases. As for the pathohistological changes in bone tissue, the following ones were the most significant: necrosis and the presence of an inflammatory infiltrate of varying severity depending on the phase of the inflammatory process. The articular cartilage structure was broken in all the cases. Activation of osteoclasts was observed in the osteomyelitis focus, especially in the subchondral zone. There was no subchondral bone plate in most cases, or only its fragments remained. Pathohistological examination of the soft tissues associated with the osteomyelitis focus indicated the presence of mirocirculatory and denervation disorders due to necrosis and hyalinosis of a significant part of microvessels against the background of compensatory hypervascularisation and chronic inflammation, narrowing and obliteration of the lumens of feeding arteries, almost complete absence of nerve elements in the tissues or their destructive changes. An increase in the activity of lytic enzymes was revealed in the interstitial environment of the tissues surrounding the osteomyelitis focus (138-fold increase in the activity of acid phosphatase, interstitial osteolytic index was 7.2-fold higher than blood serum index).

CONCLUSION: The pathomorphological signs of chronic osteomyelitis subacute and acute processing were observed in most patients. Breaking the articular cartilage structure was accompanied by invasion of vessels, inflammatory infiltrate, and by activation of osteoclasts in the subchondral zone. Destructive changes of vessels and nerves in the soft tissues associated with the osteomyelitis focus can be etiopathogenetic factors of this disease development. The technologies for stopping this process should be based on obligatory debridement of the focus with sequestrnecrectomy, with regular monitoring of the operated segment condition.

BACKGRAUND: Now the trend of Type 2 Diabetes Mellitus (T2DM) management from glucocentric to cardioprotective approach take place, and it especially relevant for the multiple group of patients with T2DM using Sulphonylurea (SU). Meanwhile the synchronized glucocardiomonitoring allowed to providing the accurate information about the cardiometabolic status of patients with T2DM.

AIMS: Using the professional glucocardiomonitoring for T2DM-SU patients to investigate the relation between the glycemic variability, integral glycemic parameters and proarrhythmogenic cardiovascular events and the long-term cardiovascular outcomes.

MATERIALS AND METHODS: In the observational (randomised for inclusion of patients) controlled trial the SU-patients with the T2DM duration 9,8±6,6 years were included, whom the professional glucocardiomonitoring had been made during 5 days and then the fatal and non-fatal cardiovascular events had been investigated during 5 years.

 RESULTS: From 283 patients with T2DM 154 patients (the basic group) used gliclazide (original drug Diabeton MB), 129 patients (the control group) used glibenclamide. The relation between the rising of the glycemic variability and cardiovascular events (the prolongation QT interval, the ST depression (dST), ventricular arrhythmias (VAs)) were demonstrated. At the basic and the control groups the coefficient of variation (CV) was 23,0±8,1 and 30,1±10,7% respectively (p<0,001), TIR-HYPO — 0,8±2,4 and 3,5±5,4% (p<0,001), the number of glycemia differences > 4 mmol/L/hr — 2,3±3,6 and 3,5±4,3 (p=0,010), the minimal glycemia level — 4,6±1,0 and 3,9±1,4 mmol/L (p=0,001). The followed differences of cardiovascular parameters were determined: QTc — 412±24 and 423±28 ms (p=0,001), dST — 0,052 [0; 0,275] and 0,109 [0; 0,422] (ratio, p=0,012), VAs — 2,2 [0; 5,9] and 3,5 [0; 8,3] (cases/pts, p=0,008). The long-term cardiovascular outcomes from the gliclazide and glibenclamide therapy (cases/100 pts-years): the total and cardiovascular death — 0,12 [0; 1,74] and 0,76 [0; 4,62] (p=0,062), cardiovascular death -0,12 [0; 1,74] and 0,62 [0; 4,08] (p=0,122), myocardial infarction — 1,56 [0; 6,94] and 2,00 [0; 8,02] (p=0,193), stroke — 0,78 [0; 4,66] and 0,76 [0; 4,62] (p=0,169), chronic heart failure — 0,52 [0; 3,72] and 1,24 [0; 6,06] (p=0,095), MACE — 2,46 [0; 10,1] и 2,62 [0; 9,38] (p=0,095), severe hypoglycemia at home — 2,46 [0; 9,12] и 7,24 [0; 16,68] (p<0,001).

CONCLUSIONS: It was demonstrated that the gliclazide (original drug Diabeton MB) administration is characterized with the better quality of glycemia control, the lower glycemic variability, the lower frequency of the SU-associated hypoglycemia, dST, VAs, the lower prolongation QTc interval. The implementation of the synchronized glucocardiomonitoring is necessary for minimization of the cardiovascular T2DM-complications and for the choice of the personalized 

There are quite a lot of scientific works today dedicated to the role of disorders carbohydrate metabolism (DCM) in the development of end-stage renal disease (ESRD), at the same time, the influence of chronic kidney disease (CKD) on the development of carbohydrate disorders remains insufficiently studied, especially in patients on renal replacement therapy (RRT). The annual steady increase in the number of patients with ESRD without diabetes mellitus (DM) requiring dialysis therapy leads to increased interest and the need to study carbohydrate status in these patients. It is known that hyperglycemia in patients without DM on hemodialysis (HD) is a predisposing factor to the development of cardiovascular accidents that worsen the quality of life and also increase mortality. The peculiarities of glucose metabolism in patients receiving RRT do not always allow adequate assessment of carbohydrate status using glycated hemoglobin (HbA1c). The review provides up-to-date information on the prevalence of DCM in patients with ESRD without DM receiving HD RRT, touches upon the peculiarities of glucose metabolism, interpretation of HbA1c and glycated albumin values, and mortality risk in hemodialysis patients with various DCM.

Diabetes of both type 1 and type 2 is characterized by a progressive loss of β-cell mass, which contributes to the disruption of glucose homeostasis. The optimal antidiabetic therapy would be simple replacement of lost cells, but at present, many researchers have shown that the pancreas (PZ) of adults has a limited regenerative potential. In this regard, significant efforts of researchers are directed to methods of inducing the proliferation of β-cells, stimulating the formation of β-cells from alternative endogenous sources and/or the generation of β-cells from pluripotent stem cells. Factors that regulate β-cell regeneration under physiological or pathological conditions, such as mediators, transcription factors, signaling pathways and potential pharmaceuticals, are also being intensively studied. In this review, we consider recent scientific studies carried out in the field of studying the development and regeneration of insulin-producing cells obtained from exogenous and endogenous sources and their use in the treatment of diabetes. The literature search while writing this review was carried out using the databases of the RSIC, CyberLeninka, Scopus, Web of Science, MedLine, PubMed for the period from 2005 to 2021. using the following keywords: diabetes mellitus, pancreas, regeneration, β-cells, stem cells, diabetes therapy.

Obesity and associated metabolic diseases are often accompanied by changes in the gut microbiota leading to metagenome gene diversity decrease. Fecal microbiota transplantation (FMT) is one of the most effective methods for correcting the  intestinal microflora. FMT obtained from healthy donors has been proven to be an effective treatment of infections caused by Clostridium difficile. The use of FMT for correction of metabolic disorders is promising, however, data on its application is limited and has contradictory results. In our work, two patients (siblings) presented with obesity grade II and various types of diabetes mellitus (DM): the older brother (44 years old) with diabetes mellitus type 2 (DM 2), a younger brother (39 years old) with diabetes mellitus type 1 (DM 1). Both patients underwent FMT as part of complex antidiabetic therapy. During the course of treatment, a decrease in body weight was noted in both patients (4–5 kg for the first month of observation, then -1–2 kg per month). One year after FMT, a patient with type 2 diabetes showed a decrease in the severity of insulin resistance (IR), measured by the hyperinsulinemic euglycemic clamp test (initial M-index 2.42 mg/kg*min, after 1 year — 3.83 mg/kg* min) as well as the maintenance of satisfactory carbohydrate metabolism compensation against the diminishing the hypoglycemic therapy. In a patient with DM 1, no significant dynamics of carbohydrate exchange indices, including detected glycated hemoglobin (HbA1c), insulin dose and IR were during the observation period. Metagenomic sequencing of stool samples (n = 20) collected from both patients before and within 1 year after FMT showed no significant changes in the taxonomic profile of the microbiota at the level of microbial families. Metabolomic analysis of the composition of feces showed no directed changes in the composition of metabolites after the FMT procedure, the nature of changes within the samples from each patient during the entire study period was random. Thus, FMT had no effect on the course of DM1, but served as a starting point for weight loss and improvement glucose profile in DM2. However, convincing data confirming a causal correlation between FMT and improvement in the course of T2DM have not been obtained.