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Objective: The aim of the study was to assess the effectiveness and safety of long-term sibutramine therapy in routine clinical practice. Methods: In total, 98,774 patients (82.3% women, 17.7% men) from 142 cities of the Russian Federation were enrolled in the PRIMAVERA program. The mean age of the patients was 39.39 ± 10.38 years, the mean body weight was 99.1 ± 14.28 kg, and the mean BMI was 35.7 ± 4.41 kg/m2. The duration of the sibutramine therapy was determined by physicians: 59.3% of patients took the drug for 6 months, the treatment course of 37.7% of patients was 12 months, and 3% of patients had treatment for 3 months. Results: The BMI reduction correlated with the treatment duration: 3.4 ± 1.53 kg/m2 after 3 months of therapy, 5.4 ± 2.22 kg/m2 after 6 months, and 7.2 ± 3.07 kg/m2 after 12 months. The body weight reduction after 3, 6 and 12 months of treatment was 9.5%, 15.1%, and 19.7%, respectively. The body weight loss associated with sibutramine treatment was accompanied by a slight decrease in blood pressure and did not lead to any significant increases of the heart rate. Conclusions: The results of the PRIMAVERA study confirmed the lack of increased risk of using sibutramine in routine clinical practice in patients without underlying cardiovascular disease and low rate of adverse events.

Empagliflozin, an inhibitor of sodium–glucose symporter type 2 (SGLT2), is a new class of antidiabetic agents with numerous pleiotropic effects. The review summarises data on the influence of empagliflozin on the structural and functional changes in the kidneys of the models of diabetes mellitus (DM) and of patients with DM. A literature search was conducted using the databases of Medline/PubMed, Scopus, Web of Science, ClinicalTrials.gov and eLibrary. The experimental results showed a decrease in the blood glucose level, blood pressure, glomerular hyperfiltration and overexpression of proinflammatory and fibrogenic factors in the kidneys under the influence of empagliflozin. Most clinical studies have demonstrated the albuminuria-lowering effect of empagliflozin in patients with type 2 DM. The EMPA-REG OUTCOME study has demonstrated slowing of the chronic kidney disease progression, decrease in the incidence of end-stage renal failure and death from renal causes in patients with type 2 DM undergoing the empagliflozin treatment compared with those receiving placebo. The mechanisms of the nephroprotective effect of empagliflozin included systemic and renal effects. The decrease in hyperglycaemia, blood pressure and body weight; reduction in glomerular hyperfiltration; enhancement of sodium excretion and suppression of inflammatory and fibrogenic signalling pathways in the kidneys may help slow the development of diabetic kidney damage under the influence of empagliflozin. The possibility of extrapolating the confirmed properties of empagliflozin to other SGLT2 inhibitors needs further investigation.

Nenets are Samoyedic people belonging to Ural contact minor race, with combined anthropological signs of both Caucasoid and Mongoloid races. In this population, the occurrences of type 1 diabetes mellitus (T1DM) were registered during 30 years. Aim. The study aimed to investigate the incidence of human leucocyte antigen (HLA)-haplotypes in Nenets compared with those in the Russian population. Materials and Methods. HLA-typing was performed in 61 healthy Nenets subjects residing in the Arkhangelsk district, 341 Russian subjects from Moscow and natives from the Vologda district. Results. DRB1*04-DQA1*0301-DQB1*0302 was similar in all the three study populations: 11.5%, 8.5% and 11.6% for Nenets, Moscow and Vologda populations, respectively (p > 0.05). However, the incidence of the second most important high predisposed haplotype DRB1*17(03)-DQA1*0501-DQB1*0202 was significantly lower in Nenets (1.6%) than in the Moscow and Vologda populations (10% and 7.4%, respectively) [(p1.2 = 0.03 (x2 = 4.42); p1.3 = 0.12 (x2 = 2.46)]. The incidence of DRВ1*01-DQA1*0101-DQB1*0501 haplotype specific for both Russian populations was also significantly lower in Nenets (3.3%) than in the Moscow and Vologda populations (11% and 12.4%, respectively) [(p1.2 < 0.05 (x2 = 3.34); p1.3 < 0.05 (x2 = 3.85)]. The incidence of protected haplotypes (DRB1*11-DQA1*0501-DQB1*0301 and DRB1*13-DQA1*0102-DQB1*0602/8/DRB1*13-DQA1*0103-DQB1*0602) was significantly higher in Nenets than in the Moscow and Vologda populations: 32.8% versus 12.5% and 9.1%, respectively [(p1.2 < 0.001 (x2 = 13.48); p1.3 < 0.001 (x2 = 17.3)] and 16.4% versus 8.5% and 11.1%, respectively [(p1.2 = 0.07 (x2 = 3.14); p1.3 = 0.3 (x2 = 0.97)]. The incidence of some neutral haplotypes was also significantly higher in Nenets: haplotype DRB1*12-DQA1*0501-DQB1*0301 was detected in 29.5% of Nenets compared with 2.5% and 1.2% of the Moscow and Vologda populations, respectively [(p1.2 < 0.001 (x2 = 42.43); p1.3 < 0.001 (x2 = 37.66)]; haplotype DRB1*09-DQA1*0301-DQB1*0303 was detected in 14.8% of Nenets compared with 1% and 2.5% of the Moscow and Vologda populations, respectively [(p1.2 < 0.001 (x2 = 21.9); p1.3 < 0.001 (x2 = 10.04)]. Conclusions. According to preliminary evidence, the incidence of predisposed haplotypes was significantly lower and that of protected haplotypes was significantly higher in Nenets than in the Moscow and Vologda populations, which probably play a role in the very low incidence of T1DM in Nenets.

Aim. To study the quantity of endothelial progenitor cells (EPCs) and levels of vascular endothelial growth factor A (VEGF-A) in patients with type 2 diabetes mellitus (T2DM) after endovascular interventions on coronary and peripheral arteries. Materials and methods. We observed 68 patients with stable angina pectoris and critical limb ischaemia, admitted for elective percutaneous coronary intervention and endovascular revascularisation of the lower extremity. The number of CD34+VEGFR2+CD45- and CD34+CD133+CD45- cells and levels of VEGF-A were determined before endovascular intervention and 2–4 days after the surgery. Results. We found that in patients without diabetes, the levels of EPCs increased significantly after endovascular interventions (CD34+VEGFR2+CD45-cells, p < 0.0001; CD34+ CD133+CD45-cells p = 0.041). The levels of EPCs in the peripheral blood of patients with T2DM before and after endovascular interventions did not significantly differ. The analysis of VEGF-A showed a statistically significant increase after intervention in both groups. In addition, in patients with an HbA1c level of 10 years, the levels of EPCs before and after endovascular interventions did not significantly differ. Conclusions. Patients with diabetes exhibited impaired EPC mobilisation after endovascular interventions. Poor glycaemic control and a long duration of diabetes are among the risk factors of EPC mobilisation.

Aim. We analysed the main epidemiological characteristics of diabetes mellitus (DM) in the Russian Federation (prevalence, incidence, mortality and mean life span), degree of diabetes control, and prevalence of diabetic complications (retinopathy, nephropathy, and diabetic foot syndrome and macrovascular pathology) according to the federal DM registry. Materials and methods. The database of the federal DM registry of 79 regions was included using the online system until 31.12.2016. Results. TThe total number of patients with DM in the Russian Federation on 31.12.2016 was 4.348 million (2.97% of the population), comprising 4 million patients with DM2 (92%), 255,000 with type 1 diabetes (T1DM) (6%), and 75,000 with other types of DM (2%). DM prevalence per 100,000 population was as follows: T1DM, 164.19/100,000; type 2 diabetes (T2DM), 2637.17/100,000; and other types of DM, 50.62/100. The incidence per 100,000 population was as follows: T1DM, 16.15/100,000; T2DM, 154.9/100,000; and other types of DM, 8.65/100,000. Mortality per 100,000 population was as follows: T1DM, 2.1/100,000; T2DM, 60.29/100,000; and other types of DM, 0.57/100,000. Mortality decreased in patients with T1DM by 6.6% and with T2DM by 3.6%. Mean life span in patients with T1DM was 50.3 years for men and 58.5 years for women. Mean life span in patients with T2DM was 70.1 years for men and 75.5 years for women. Glycated haemoglobin A1c (HbA1c) levels in T1DM was

Pharmacoepidemiological research is the first stage of the clinical and economical evaluation of treatment with pharmaceutical agents. It plays an important role in providing reliable information about treatment regimens for patients with type 2 diabetes mellitus (T2DM). The results of the analysis of the utilisation of hypoglycaemic drugs are country specific and are associated with different epidemiological characteristics of the disease, cost of drugs and financing of the healthcare system. Analytical pharmacoeconomic studies allow the evaluation of the rational use of drugs, characteristics of treatment in clinical practice and their conformity to national and international clinical guidelines. Aim. To study the characteristics of treatment with insulin and oral hypoglycaemic drugs in Moscow-based patients with T2DM and to calculate the average cost of hypoglycaemic drugs per person per year. Materials and methods. A retrospective cohort pharmacoepidemiological study was performed by analysing information from the national register of diabetic patients from two administrative districts in Moscow. In total, 48,978 adult patients (older than 18 years) were registered with T2DM between 2000 and 2012. The study of treatment regimens was conducted using the standard international ATC/DDD methodology, and the correlation of fixed dose to appointed daily dose was calculated. The annual average cost of treatment for patients with T2DM, including different hypoglycaemic drugs (insulin and oral hypoglycaemic drugs) in the form of monotherapy and different combinations, was calculated. The average annual cost of hypoglycaemic therapy for patients with T2DM was calculated for the first time in the Russian Federation. Results. The majority of study patients received hypoglycaemic drugs (98.5%), and only 1.5% of the patients diagnosed with T2DM were on dietetic therapy. Of the patients receiving drugs, 90% received oral hypoglycaemic drugs, and 10% received insulin (basal-bolus regimen 4.6%, basal insulin with oral hypoglycaemic drugs 3.8% and ?MIX-insulin? 1.1%). The most frequently prescribed oral hypoglycaemic drugs were derivatives of sulphonyl urea and metformin (87% and 71%, respectively), and 12% of the patients received premixed combinations of these drugs. Other groups of oral hypoglycaemic drugs accounted for only a small proportion of oral hypoglycaemic drugs (approximately 2%) and included glinide (1.8% of the patients), thiazolidinedione (0.4%) and inhibitors of alpha-glucosidase (0.17%). In the group of derivatives of sulphonyl urea, the most frequently prescribed drugs were glibenclamide (46.4%), gliclazide (38.7%) and glimepiride (14%). The average annual treatment cost per patient was 7,467 rubles. Conclusion. The pharmacoeconomic analysis revealed that the treatment of T2DM was insufficiently effective in 48% of the patients (HbA1c>7%). Most patients received monotherapy with metformin or derivatives of sulphonyl urea, among which glibenclamide was the most frequently prescribed drug. The treatment of patients with T2DM in 2011 was characterized by a low frequency of insulin prescription, rare usage of other groups of oral hypoglycaemic drugs (only 2%) and a mismatch between fixed dose and appointed daily dose. The average annual cost of hypoglycaemic drugs per patient with T2DM in 2011 in Moscow was 7,467 rubles.

The extent of damage to the nervous, vascular and microcirculatory systems in diabetic patients determine the regulation of physiological events that lead to the formation of chronic wounds, reduction of patient quality of life and increase of the financial value of medical care. Successful physiological repair is impossible without the successive phases of inflammation, proliferation and wound healing. Keratinocytes are the major cellular barrier components of the epidermis. These cells play an important role in physiological repair, as suggested by recent research, with many cells able to secrete steroid hormones de novo. Damage to the integrity of the skin leads to keratinocyte activation, triggering a cascade of reactions that contribute to changes in epidermal cell phenotype and lead to their proliferation and migration, analogous to changes in cellular adhesion and configuration of the cytoskeleton. An open question remains as to how the keratinocyte cell cycle, which is altered under conditions of hyperglycemia, and neurotransmitter metabolism during different stages of physiological repair are regulated. Understanding these processes will provide a scientific basis for the development of new targets for pharmacotherapies.

Improved prognoses of patients with type 2 diabetes are primarily determined by the extent of blood glucose control (correction of both hyper- and hypoglycemia and normalization of blood glucose levels). The proper identification and timely correction of abnormal blood glucose levels require frequent blood glucose monitoring by the patient. Currently used methods for the self-monitoring of blood glucose have significant drawbacks that limit their use. The most significant problems with these methods include insufficient accuracy, invasiveness and high cost, leading to noncompliance and difficult assessment of disease status. Such factors underscore the need for a noninvasive, cost-effective and highly accurate method to measure blood glucose levels. There are several different approaches for the noninvasive measurement of blood glucose levels, including optical analysis, ultrasound and bioimpedance. The concept of a noninvasive glucometer was launched more than 30 years ago. Nevertheless, most noninvasive technologies are still in early stages of development and are not used in clinical practice. This review describers the most promising developments in this area.

Glucagon like peptide-1 (GLP-1) analogues and dipeptidyl peptidase-4 (DPP-4) inhibitors are new classes of hypoglycemic agents with numerous pleiotropic effects. The review summarises data about the influence of GLP-1 analogues and DPP-4 inhibitors on structural and functional changes in diabetic kidneys. Growing evidence indicates that the kidney is one of the loci of the effects and degradation of GLP-1. The potency of the effects of GLP-1 in diabetic kidneys can be reduced by decrease in GLP-1 receptor expression or enhancement of GLP-1 degradation. In experimental models of diabetic nephropathy and non-diabetic renal injury, GLP-1 analogues and DPP-4 inhibitors slow the development of kidney fibrosis and prevent the decline of kidney function. The mechanisms of protective effect include hyperglycaemia reduction, enhancement of sodium excretion, suppression of inflammatory and fibrogenic signalling pathways, reduction of oxidative stress and apoptosis in the kidneys. In clinical studies, the urinary albumin excretion reduction rate while using the GLP-1 analogue and DPP-4 inhibitor treatment was demonstrated in patients with type 2 diabetes. Long-term impact of these agents on renal function in diabetes needs further investigations.

Type 1 diabetes mellitus (T1DM) was used from the viewpoint of human immunogenetics as an example of the most widely studied immunity-mediated disease. This was done in order to develop, approve and implement a new clinical approach to determine immunity-mediated susceptibility or resistance to autoimmune diseases. The approach is based on analysis of entire HLA-DRB1 genotypes (not separate HLA-DRB1 haplotypes) of the study participants. Therefore, more effective and personalised classification of T1DM risk groups was achieved by exclusion from significant contingents.

Objective.To estimate annual expenditures attributed to diabetes mellitus (DM) per patient in Russia based on data from epidemiologic studies and to analyse DM cost drivers.Methods.The expenditures per diabetic patient were calculated as the sum of medical costs (outpatient and emergency room visits, inpatient care and medications provided during outpatient care), payments for sick leaves, disability pensions and gross domestic production (GDP) losses due to temporary disability (indirect costs). All data on resource consumption and productivity losses were derived from the dataset for Russia, collected from the point of view of a multicentre international study on the practice of DM treatment. Medication costs were based on registered governmental price lists (list of vital and essential drugs). Medical care costs were estimated using the approved public health care reimbursement rates. Disability payments were calculated on the basis of data published by the Russian Pension Fund and Social Security Fund. GDP losses were assessed using federal statistics.Results.The mean total annual costs per patient with DM type 1 (T1) were 81.1 thousand Russian rubles (RUR) and those per patient with DM type 2 (T2) were 70.8 thousand RUR. Although most patients with DMT2 were >60 years, approximately 25% of costs were nonmedical and caused by productivity losses; for patients with DM type 1(T1), this proportion was 35%. The medical cost structure differed depending on the type of diabetes. In T1, the main component was attributed to DM treatment; in DMT2, almost half of medical costs were due to DM complications. Medication costs accounted for 69% and inpatient care accounted for only 22% of medical costs in DMT1. For DMT2, the proportion spent on inpatient care (43%) was almost equal to medication costs (46%). Mean expenditures per patient with DM complications were higher; in the case of DMT2, the presence of complications increased the costs by 3 times. Mean medical costs were higher for patients not reaching the target level of Hb1Ac than those reaching it, despite age or the presence of complications. The results of regression analysis showed that the strongest predictors of costs growth were the number of admissions, presence of complications and insulin treatment. It was also demonstrated that the mean medical cost per patient with uncomplicated DM T2 on insulin therapy was 38.5 thousand RUR, which was comparable to the cost per patient with complications, receiving other glucose-lowering treatment (37.0 thousand RUR).Conclusion.Costs for patients with DM complications are considerably higher than those for patients without complications. Therefore, the key point in controlling the growth of the DM economic burden is to minimise and/or prevent the development of DM complications, which could be achieved by timely DM diagnosis and appropriate glucose-lowering therapy.

During 2007-2012 years the ?Diabetes mellitus? sub-programme reached the performance targets with the following results. Development of the State Diabetes Register covering all regions of the Russian Federation. The Register facilitates the continuous evaluation and planning of diabetes care in this country, analysis of epidemiological dynamics (including incidence and mortality in diabetes population) and human resources management.Alteration of the demographics of the national diabetes population, specifically: - an increase in life expectancy among T1DM patients: up to 56.7 years (+3.8 years) in males and up to 60.8 years (+4.1 years) in females; an increase in life expectancy among T2DM patients: up to 72.4 years (+3.2 years) in males and up to 74.5 years (+2.9 years) in females; - a reduction in mortality of diabetes patients for 28.4%; Introduction of novel technologies for diagnostics, prevention and management of DM and its complications, that, in turn, allowed to: - decrease the incidence of diabetic nephropathy for 16.1% and extend the pre-dialysis period; - decrease the incidence of diabetic retinopathy for 11.4% and preserve vision in 86-91% patients who still develop this complication; - decrease the frequency of upper- and lower-level amputations for 24% and 28%, respectively, and to reduce the ulcer healing times 2.5 to 3-fold;Introduction of safe and highly efficient human recombinant insulin and its analogues in the regions of the Russian Federation, along with modern methods of insulin administration and outpatient blood glucose monitoring.Establishment of diabetes educational centres (more than 1100 in the regions of the Russian Federation) that resulted in substantial reduction of number and frequency of diabetes-associated hospital admissions.The sub-programme is estimated to have saved 6 727 596.9 thousand Russian rubles of the budgetary funds due to decrease in the incidence of microvascular complications. A total of 360 papers (including 35 in international medical journals), as well as 81 clinical guidance manuals and 23 monographs were published during the course of this sub-programme.

Aim. To study quality of life (QoL) and hypoglycaemic symptoms in patients with type 2 diabetes receiving intensive insulin therapy.Materials and methods. One thousand patients with type 2 diabetes receiving intensive insulin therapy for at least 6 months were enrolled in this multicenter observational study. The mean age of patients was 61.1 years (range, 29–84 years) and the male/female ratio was 265/735. All patients completed the SF-36® questionnaire and the Comprehensive Symptom Profile-Diabetes Mellitus Hypoglycemia Module. For group comparisons, we used unpaired t-tests or Mann–Whitney tests and general linear models. To compare categorical variables, the χ2 test and Fisher’s exact test were used.Results. The patients with type 2 diabetes receiving intensive insulin therapy demonstrated heterogeneity in terms of QoL. More than half of the patients had mild QoL impartment while nearly one third experienced significant QoL impairment. The following factors had the most pronounced negative impact on QoL: late diabetic complications, concomitant diseases, poor glycemic control and type of hypoglycaemia. QoL parameters were lower in patients with hypoglycaemic episodes than in those without (p

Basal insulin represents an essential tool in the treatment of both type 1 and type 2 diabetes mellitus. The development of insulin analogues has improved the possibilities of diabetes treatment. Despite significant progress in understanding the physiology, chemistry, kinetics and action of insulin, currently available basal insulin products do not optimally mimic the endogenous profile of insulin. Although basal insulin analogues have some advantages over neutral protamine Hagedorn insulin in diabetes treatment, hypoglycaemia remains the main problem in the achievement of optimal glycaemic control in most patients with diabetes. These unmet clinical needs have stimulated the development of new basal insulin analogues with improved pharmacological profiles. This article reviews the specific characteristics of new long-acting insulin analogues to try and understand their benefits and limitations in the improvement of diabetes management and their possibilities in physiologic and safe insulin replacement.

Recent data suggest that chronic critical limb ischaemia (CLI) is the most important reason for amputation among diabetic patients. The high prevalence of CLI in this patient group is associated with specific clinical and morphological properties of peripheral arterial disease. Percutaneous transluminal angioplasty is an appropriate primary therapy, but it is not considered early in the disease process, and is instead reserved as a limb salvage strategy. Low primary patency, despite optimal clinical effects, remains a typical issue of percutaneous transluminal angioplasty for diabetic patients in particular. Thus, the indications, technical success and clinical results of endovascular revascularisation need to be clarified in patients with diabetes. Although difficult, the procedure can be effective through a multidisciplinary approach.

The prevalence of type 2 diabetes is increasing dramatically, and the pathogenesis of the disease has been studied extensively in recent years. Of particular interest, incretins are reported to cause changes in insulin secretion that affect the natural development of the disease. The emergence of new drugs that act via the incretin axis have led many clinicians to consider their place in clinical practice.

Creating an "artificial pancreas" (a "closed loop" insulin pump, with self-adjusting insulin abilities, based on real time continuous glucose monitoring data) – is one of the most actual medical challenges of modern engineering and cybernetics.Artificial pancreas (AP) prototypes based on wearable insulin pump with subcutaneous insulin delivery are still problematic, mainly because of slow insulin pharmacokinetics. Intravenous insulin infusion via AP allows effectively maintain euglycaemia for inpatients, due to insulin pharmacokinetics and pharmacodynamics advantages. Unfortunately, it can’t be used for outpatients. Intraperitoneal insulin infusion is still relatively infrequently used in the world, but it is a promising alternative, compared to both previous methods due to a physiological action profile, fast insulin pharmacokinetics, relatively better safety and availability for outpatient usage.The purpose of this review is to describe the intraperitoneal insulin infusion features for diabetes patients at a point of AP creation perspectives.

Clinical and epidemiological monitoring of diabetes in Russian Federation (RF) is carried out by the National diabetes register, which methodological and organizational reference center is Federal Endocrinology Research Centre. Since 2014 initiated the translation the National diabetes register on online software system in order to increase the effectiveness of the register as a scientific and analytical platform. The article include the analysis of DM prevalence, incidence,DM-related mortality,the prevalence of diabetic complications and analysis of effectiveness of diabetes care (included HbA1c) and according to the data of online register.

Aims. To evaluate long-term efficacy of CSII for treating type 2 diabetes patients. To make an attempt to predict which patient would be more likely to reduce HbA1c levels (success) on CSII. Methods. 18 Type 2 diabetes patients who began insulin pump therapy in our institute were included. All patients were previously treated by insulin with a mean duration of 54.9?51.4 months. Results. Mean duration of follow-up with CSII was 42.2?27.0 months. No significant changes were seen in HbA1c in total cohort (p=0.064), but fasting plasma glucose was reduced from 10,5?2,9 to 7,6?1,9 mmol/l, p=0.007. No weight gain and no severe hypoglycemia were noted. All patients were divided to three groups according to their HbA1c levels: those whose treatment was successful (A), failed (B) or neutral (C), (5, 8, 5 patients respectively). A difference was found in insulin/weight (IWR) ratio within the group A: 0.81?0.29 U/kg before vs. 0.41 ?0.12 U/kg on CSII, p=0.043. There was a difference in IWR on CSII in group A compared to group B (0.41 ?0.12 U/kg vs. 0.93?0.6 U/kg respectively, p=0.011). We also noted a trend of weight reduction in the group A vs. weight gain in the group B. Conclusions. CSII is a viable tool in insulin ? requiring type 2 diabetes persons, since the insulin dosing and release it provides are much more physiological. CSII is safe and effective for improving glycemic control, but not in all diabetes patients. We suggest IWR reduction may serve as an early predictor of success on CSII. This work may serve as a "proof-of-concept" study, demonstrating once again the fundamental role of strict weight control in type 2 diabetes. More studies are needed to explore and confirm our experience.

The current update of the consensus algorithm of initiation and intensification of the antihyperglicemic therapy in treatment of the patients with type 2 diabetes mellitus (2015) is based on the preliminary document issued by the Russian Association of the Endocrinologists in 2011. The update was needed due to new data on the safety of the traditional therapeutic options, availability of the new class of the antidiabetic medications, and necessity to add chapter about initiation and intensification of the insulin therapy. The patient-centered approach remains the absolute priority at any stage of diabetes care as it ensures the efficacy and safety of antihyperglycaemic treatment.

We are glad to present the 7th Edition of Standards of Diabetes Care.These evidence-based guidelines were designed to standardize and facilitate diabetes care in all regions of the Russian Federation.The Standards are updated on the regular basis to incorporate new data and relevant recommendations from national and international clinical societies, including World Health Organization Guidelines (WHO, 2011, 2013), International Diabetes Federation (IDF, 2011, 2012, 2013), American Diabetes Association (ADA, 2012, 2015), American Association of Clinical Endocrinologists (AACE, 2013), International Society for Pediatric and Adolescent Diabetes (ISPAD, 2014) and Russian Association of Endocrinologists (RAE, 2011, 2012).Current edition of the ?Standards? also integrates results of completed randomized clinical trials (ADVANCE, ACCORD, VADT, UKPDS, etc.), as well as findings from the national studies of diabetes mellitus (DM), conducted in close partnership with a number of Russian hospitals.Latest data indicates that prevalence of DM increased during the last decade more than two-fold, reaching some 387 million patients by the end of 2014. According to the current estimation by the International Diabetes Federation, 592 million patients will be suffering from DM by 2035. These observations resulted in the UN Resolution 61/225 passed on 20.12.2006 that encouraged all Member States "to develop national policies for the prevention, treatment and care of diabetes".Like many other countries, Russian Federation experiences a sharp rise in the prevalence of DM. According to Russian State Diabetes Register, there are at least 4.1 million patients with DM in this country. However, the epidemiological survey conducted by the Federal Endocrinology Research Centre during 2002-2010 suggests that actual prevalence is 3 to 4 times greater than the officially recognized and, by this estimate, amounts to 9-10 million persons, comprising 7% of the national population.Severe consequences of the global pandemics of DM include its vascular complications: nephropathy, retinopathy, coronary, cerebral and peripheral vascular disease. These conditions are responsible for the majority of cases of diabetes-related disability and death.Current edition of the "Standards" emphasizes the patient-oriented approach in making decisions on therapeutic goals, such as levels of glycaemia and blood pressure. It also features updated guidelines on the management of vascular complications.This text represents a consensus by the absolute majority of national experts, achieved through a number of fruitful discussions held at national meetings and forums. These guidelines are intended for endocrinologists and diabetologists, primary care physicians, cardiologists and other medical professionals involved in prevention and treatment of diabetes mellitus.

Current document presents the expert consensus of Russian Association of Endocrinologists and Russian Society of Obstetrician- Gynecologists on diagnostic criteria of gestational diabetes and other glycemic disorders of pregnancy. The consensus is based on analysis of HAPO (Hyperglycemia and Adverse Pregnancy Outcomes Study) - a major multinational study, that included more than 23000 patients. Project of current consensus was repeatedly discussed during meetings of the research group and publicly addressed at 6th Pan-Russian Congress of Endocrinology with international participation ?Modern Endocrine Technologies?, as well as Pan-Russian Educational Interscience Conference ?Complicated Pregnancy and Preterm Birth?.

Current document presents a coherent viewpoint of Russian Association of Endocrinologists and Russian Association of Obstetriciansand Gynaecologists on diagnostic criteria of gestational diabetes mellitus (GDM) and other glycemic disorders during gestation. Currentapproach is based on analysis of high-profile multinational study HAPO (Hyperglycemia and Adverse Pregnancy Outcomes Study),which included more than 23 000 pregnant women. This project was repeatedly reviewed on workgroup sessions and presented orallyon 6th Russian Congress of Endocrinology with international participation, as well as Russian interdisciplinary educational congressGestational Complications and Premature Delivery.

По данным Государственного регистра больных сахарным диабетом, на 1 января 2009 года в России сахарный диабет (СД) выявлен более чем у 3 миллионов человек, из них 2,7 миллиона приходится на 2 тип. Последние 15-20 лет интерес к выбору оптимальной терапии на всех этапах развития СД 2 типа возрастает. Это связано с одной стороны с появлением новых научных данных, а с другой стороны со всё увеличивающимися возможностями фармакологического воздействия у этой категории больных. В настоящее время специалисты выделяют 9 групп таблетированных и инъекционных препаратов. Эти данные представлены в одном из самых важных опубликованных за последнее время международных документов ? совместном консенсусе Американской Диабетической Ассоциации (ADA) и Европейской Ассоциации по исследованию диабета (EASD), а также в недавно опубликованном Консенсусе Американской Ассоциации Клинических Эндокринологов (AACE)/ Американской Коллегии Эндокринологов (ACE). В этом обзорном документе специально оговаривается сравнение различных препаратов в виде следующего заявления: в настоящее время недостаточно данных, чтобы поддержать рекомендацию по какому-то конкретному классу сахароснижающих препаратов или их комбинации в отношении влияния на предупреждение осложнений. Поэтому, справедливо судить и сравнивать сахароснижающие агенты, так же, как и их сочетание, в первую очередь по их способности снижать и поддерживать уровень HbA1c, а также по их безопасности, специфическим побочным эффектам, переносимости, удобстве в применении?. Далее в документе подчеркивается особая роль инсулина в лечении СД, обосновывая это следующим: ? инсулин является самым мощным сахароснижающим препаратом; ? своевременное начало инсулинотерапии обеспечивает оптимальный контроль гликемии и, соответственно, улучшает прогноз СД 2 типа, замедляя развитие в организме необратимых изменений; ? доказано влияние интенсивной инсулинотерапии на предупреждение развития сосудистых осложнений при диабете; ? по мере прогрессирования диабета заболеванием труднее управлять; в этом плане инсулин даёт дополнительные преимущества, поскольку его действие не зависит от остаточной секреторной активности бета-клеток. В настоящих рекомендациях будут затронуты все этапы инсулинотерапии СД 2 типа: начало, оптимизация и интенсификация.

Aim. To identify profibrogenic mediators, markers of endothelial dysfunction and hemostasis in patients with diabetes mellitus (DM) and chronickidney disease (CKD). Materials and methods. The study included 120 patients with DM and 20 age-matched normotensive subjects without DM showing the glomerularfiltration rate (GFR) > 60 ml/min/1.73 m3. Four groups of patients were distinguished: 1 - DM2 patients without renal pathology (n=33), 2 - DM2 patients with diabetic nephropathy (n=24), 3 - DM2 patients with ischemic nephropathy (IN) (n=33) verified by contrast visualization techniques(multispiral CM of abdominal aorta and renal arteries, abdominal angiography of renal arteries or MR angiography of renal arteries and abdominal aorta), 4 - DM1 patients with DN (n=30). Clinical examination included assessment of complaints, analysis of medical history of the main diseaseand concomitant disorders, determination of the main clinical and biochemical characteristics of blood and urine, measurement of НbА1с and 24-hralbuminuria (AU) by standard methods, estimation of GFR by the MDRD formula, ECG, echocardiography, 24-hr AP monitoring, counseling bycardiologist and ophthalmologist (fundal examination by ophthalmoscopy). Standard kits were used to detect profibrogenic mediators and markersof endothelial dysfunction including transforming growth factor-beta (TGF-b), angiotensin II (AT II), monocyte chemoattractant protein (MCP-1),regulated on activation normal T cell expressed and secreted (RANTES), adhesion factors (intracellular adhesion molecule (ICAM-1), vascular celladhesion molecule (VCAM-1) vascular endothelial growth factor (VEGF), interleukin-6 (IL-6), asymmetric dimethylargnine (ADMA), homocysteine(HCYST), metalloproteinases (MMP), von Willebrand factor (vWF), plasminogen activator inhibitor (PAI-I). Results. DM patients with CKD had elevated blood profibrogenic cytokine (MCP-1, TGF-1b, IL-6) and extracellular matrix degradation factor(MMP-9) levels compared with patients without CKD and healthy subjects. These changes were unrelated to the type of diabetes or the cause ofnephropathy, which suggests their contribution to renal pathology through the universal mechanism of tubulointerstitial fibrosis. Activation of profibrogeniccytokines in DM patients with CKD was closely associated with endothelial dysfunction manifest as enhanced production of blood adhesive angiogenic, thrombogenic factors (FW, PAI, VICAM, sICAM, VEGF), and endothelium-affecting factors (ADMA, homocysteine). Mediators of inflammationand fibrogenesis in these patients negatively correlated with GFR and positively with AU, the main markers of renal dysfunction. Hyperuricemia,TGF-1b, ADMA, and MCP-1 are considered to be the risk factors of impaired renal filtration function. Conclusion. The level of profibrogenic cytokines and ndothelial dysfunction factors in DM patients with different renal lesions reflects severity of tubulointerstitialfibrosis. It may be used for the purpose of prognostication and substantiation of intensification of secondary prophylaxis of renal insufficiency.

Aim. To carry out cost-effectiveness analysis of treatment options for type 2 diabetes using different groups of medicines, to prognosticate late diabeticcomplications and the cost of their management. Materials and methods. A total of 3678 DM2 patients (with mean HbAc1 level 9.3%) were examined in 23 regionsin the framework of the Diabetesmellitus subprogram of the Federal target program "Prevention and control of socially significant diseases". Two hypothetical therapeutic modalitieswere considered: treatment with NovoMix 30 and oral hypoglycemic (OHG) agents. The CORE model was used to analyse anticipated expendituresand DM outcomes. Results. Simulation revealed a greater decrease of HbA1c levels (-1.7%), reduction of total cholesterol, LDL, systolic AP (-4.1%) and risk of cardiovasculardiseases coupled to increase of HDL in patients treated with NovoMix 30. Maximum life expectancy was 17.2 yr compared with 16.5 yrin the OHG group and overall cost of the treatment 1,650,725 and 1,586,234 rubles respectively. Savings for the treatment of diabetes using NovoMix30 amounted to 19,832 rubles per patients due to reduced indirect expenditures including management of renal, cardiac, ophthalmologic , and cerebrovascularcomplications. Conclusion. Simulation of late results of DM2 treatment demonstrated enhanced pharmacoeconomic efficiency of modern insulin analogs comparedwith OHG agents.

Aim. To elucidate the relationship between glycemic control (assessed by the level of HbA1c) and psychological status of the patients. Materials and methods. The study included 115 patients with type 1 diabetes aged 13-27 years. The following tests were used to assess the psychological statusof the patients status (emotional state, social relations, attitude toward disease): State-trait-anxiety Inventory (Spielberger C.D., Hanin Y.L), Center for EpidemiologicStudies Depression Scale (CES-D), Social ajustment scale by A.K. Osnizkiy based on Q-Sort Adjustment Scale developed by R. Dymond andC.R. Rogers (1954), Lusher colour test , Colour attitudes test, A.M. Etkind original technique, method for the assessment of attitude toward disease developedin V.M. Bekhterev Research Psychoneurologic Institute, Sankt-Peterburg. The patients were allocated to 3 groups differing in terms of 33.3% percentile ofHbA1c levels. Results. Patients with good glycemic control (mean HbA1c level 7.4%) show the lowest level of social adaptation and emotional well-being. The reason for thisphenomenon is the excessive focus of patient on the disease and narrow scope of interests, which suggest psychological dependence on diabetes. Patients withpoor glycemic control (mean HbA1c level 13.1%) also experience emotional discomfort due to increased anxiety. Despite the fact they exhibit a higher degreeof social adaptation than the patients of the above group, the main concern is the low level of communicative autonomy and the feeling of being unable to copewith the disease. Such personal characteristics also create a psychological dependence on diabetes, although of a different type than in the first group of patients.Patients with average glycemic control (mean HbA1c level 9.5%) in the sample have the most favorable psychological state in comparison with the other twogroups. Their emotional state and social adaptation are significantly better than in the other two groups. These patients tend to psychological autonomy and independenceand maintain multifaceted life motivation in terms of diabetes. They perceive the disease as a given, some life condition that allows to maintaina positive psychological state, high daily activity, not to feel overwhelmed with diabetes and at the same time pay attention to diabetes self-management evennot quite sufficient.Conclusions. Glycemic control and psychological status in young adults does not coincide with each other, although there is a close relationship among them.Attitude toward the disease is the most important mediator of this relationship. Professional psychological help and educational interventions designed to developskills of the practical management of diabetes may contribute to improvement of metabolic control, psychological well-being and social adjustment of patients.

Aim. To identify factors responsible for the early development of microvascular complications in patients with type 1 diabetes mellitus (DM1)and to evaluate dependence of their prevalence on the type of insulin. Materials and methods. The study carried out from May 2002 to November 2007 included a random sample of patients with DM1 over 10 years in duration(n=5895, 100%, >=20 years) from the Central, Volga, Ural, Siberian, North-West and Southern federal districts. All patients underwentexamination of eye fundus and feet, measurement of microalbuminuria, creatinine, urea, serum lipid spectrum and HbА1с. Results. Mean HbА1с level in patients of group 1 (using insulin analogs) was significantly lower than in group 2 (using homan insulin) (Me 8,5?0,2%;9,7?0,4% SD* respectively) p>0,01. Mean daily insulin dose in group 1 and 2 was >1,0 and

According to the International Diabetes Federation, 10.9 million people have diabetes mellitus (DM) in Russia; however, only up to 4 million are registered. In addition, 11.9 million people have impaired glucose tolerance and impaired fasting glucose levels [1]. One of the significant risk factors for type 2 DM (T2DM) is obesity, which increases insulin resistance (IR). IR is the major pathogenetic link to T2DM. According to current concepts, there are three types of adipose tissue: white adipose tissue (WAT), brown adipose tissue (BAT) and ?beige?, of which the last two types have a thermogenic function. Some research results have revealed the main stages in the development of adipocytes; however, there is no general consensus regarding the development of ?beige? adipocytes. Furthermore, the biology of BAT and ?beige? adipose tissue is currently being intensively investigated, and some key transcription factors, signalling pathways and hormones that promote the development and activation of these tissues have been identified. The most discussed hormones are irisin and fibroblast growth factor 21, which have established positive effects on BAT and ?beige? adipose tissue with regard to carbohydrate, lipid and energy metabolism. The primary imaging techniques used to investigate BAT are PET-CT with 18F-fluorodeoxyglucose and magnetic resonance spectroscopy. With respect to the current obesity epidemic and associated diseases, including T2DM, there is a growing interest in investigating adipogenesis and the possibility of altering this process. BAT and ?beige? adipose tissue may be targets for developing drugs directed against obesity and T2DM.

Achievement of glycemic control is the major therapeutic aim to prevent or delay the onset and progression of diabetes related complications. Insulin therapy represents a cornerstone in the treatment of diabetes and has been used widely for achieving glycemic goals. The aim for insulin therapy is to mimic the physiological profile of insulin secretion seen in nondiabetic patients. Development of the insulin analogs has offered new opportunities in the diabetes management to achieve greater safety and tolerability of diabetes treatment. Insulin degludec/insulin aspart(IDegAsp) (Ryzodeg?, Novo Nordisk, Denmark) is the first soluble co-formulation of 70% ultra-long acting insulin degludec and 30% rapid-acting prandial insulin aspart, providing both basal insulin coverage and a prandial insulin bolus in a single injection. This review discusses data regarding the efficacy, safety, tolerability and clinical benefits of IDegAsp. According to the clinical development program IDegAspprovides an achievement of similar glycemic control with superiority in lowering FPG with using less number of injections and lower daily insulin dose, and also associated with numerically lower rates of confirmed and nocturnal confirmed hypoglycaemia in comparison with premixed or basal insulin analogues, as well as a basal component for basal?bolus therapy with supplementary mealtime insulin aspart.Trial results suggest that IDegAspQD or BID maybe an appropriate and reasonable option for initiating insulin therapy in type 1 and type 2 diabetic patients inadequately controlled on maximal doses of oral antidiabetic drugs,and also a simple alternative to basal?bolus treatment in patients who require intensification of insulin therapy, especially when adherence to more complex regimens is challenging.

Diabetes mellitus is a disease that presents a global medical problem. It is necessary to implement an in-depth analysis of the epidemiological situation of type 2 diabetes mellitus for planning and organizing specialized medical help to patients with type 2 diabetes mellitus. Aim. To rate the basic epidemiological indices of type 2 diabetes mellitus in actual clinical practice using the informational database of national registry of diabetic patients. Materials and methods. Epidemiological analyses were performed in two administrative districts of Moscow. From 1999 to 2011 48978 adult patients with type 2 diabetes mellitus who were aged 18 years and older were registered. We used methods of clinical, analytical and statistical epidemiology with elements of descriptive research. Results. The prevalence rate of type 2 diabetes mellitus was 1590 per hundred thousand, most patients were in the 60?64 and 70?74 age groups, and approximately 80% of patients were older than 55 years. The morbidity rate of type 2 diabetes mellitus was 138,72 per hundred thousand and was found to be higher in women at 1,89. The mortality rate of adult patients with diabetes mellitus was 0,83, mostly in men of all ages. Cardiovascular diseases accounted for most of the registered cases of deaths (34,4%). The average life expectancy appeared to be 75,24?0,45 years, although women lived 6 years longer than men. The average duration of the disease was 10,04?0,34 years. A total of 0,4% of patients underwent hospital treatment and the average length of treatment was 17?18 days. The total number of days of disablement was an average of 307,33?30,13 days (80% of patients were older than 55 years). In the study group, a mean grade of НbА1c

For 40 years, research continues to improve the forecasting methods and the development of effective and safe methods of preventing type 1 diabetes mellitus (T1DM). Аim. Prediction of the early preclinical stage of T1DM. Materials and methods. We studied the predisposing and protective haplotypes (HLA-DRB1, gene DQ) together with immunological markers (ICA, GADA, IAA) in 224 discordant/concordant families. Results. At the Endocrinology Research Centre, population and family risks of the development of T1DM in Russia were calculated on the basis of population genetic approaches. The analysis of the prevalence of HLA genotypes among T1DM patients revealed that the high-risk haplotypes in the structure of genotype(s) DQ2 and/or DQ8 in combination with the others were 78%: of these genotypes DQ2/DQ8, DQ2/DQ2, and DQ8/DQ8 accounted for 35%; DQ2/X* and DQ8/X* accounted for 43%; and the low-risk genotype Х*/Х* accounted for 22%. The genotype Х/Х consisted of weaker predisposing haplotypes that were specific to the Russian population in combination with neutral haplotypes or those consisting of neutral haplotypes only. The analysis of patients with T1DM genotypes revealed that high-risk genotypes (DQ2/DQ8) were more common in ill children up to the age of 5 (33% of cases) than in T1DM children over 10 years (23%) (p=0.05). Conversely, the low-risk genotypes were significantly less likely to be found in children with manifestations of diabetes up to 5 years than in sick people over 10 years [5% and 13%, respectively (p

Diabetes mellitus (DM) is characterised by relative or absolute insulin deficiency. The currently available treatment methods for DM cannot provide normal blood glucose level without hypo- or hyperglycaemia episodes, thus failing to completely prevent the development of diabetic complications. Replacement of ?-cells (transplantation of the pancreas or ?-cells) is accompanied by complications and requires life-long immunosuppressive therapy that is not always followed by restoration of insulin independence; there is also a substantial deficit of donors. Stem cells do not cause such negative effects and can be used in therapy to avoid such problems. Allogeneic stem cell transplantation is complicated by immune rejection of a transplant, whereas the use of embryonic stem cells is associated with ethical concerns, complicated cell line selection, and risk of teratoma formation. The present review focuses on therapeutic pathways of autologous transplantation of tissue stem cells in order to restore the ?-cell pool, for immune reconstitution and modulation of the immune response in DM patients.

Achieving optimal glycemic control is an important aspect of preventing and slowing the progression of diabetes-associated complications, and reducing the cost of their treatment. Long-acting insulin analogues, glargine and detemir, provide better metabolic control with reduced risk of hypoglycaemia as compared to NPH insulin. However, fear of hypoglycaemia and weight gain, as well as the complexity of regimen, are still the most important barriers to well-timed initiation and intensification of insulin therapy. Insulin degludec (Tresiba?) is a new ultra-long-acting insulin analogue. After subcutaneous injection degludec forms repository of soluble multi-hexamers, which are gradually absorbed to the bloodstream, providing a flat, stable antihyperglycemic effect lasting more than 42 h, and low intra-individual variability as opposed to currently used basal insulin analogues, insulin glargine and insulin detemir. In the seven randomized, open label, controlled phase 3 trials lasting 26 or 52 weeks, using treat-to-target (no more) non-inferiority design, insulin degludec provided glycemic control similar to that of insulin glargine with lower risk of nocturnal hypoglycaemia and good safety profile in patients with type 1 or 2 diabetes. Furthermore, trials examining a flexible dosing regimen of insulin degludec in patients with type 1 or 2 diabetes have shown that it is possible to vary the injection time without compromising glycemic control or safety of the therapy.

The method of Genome-Wide Association Studies (GWAS) steadily becomes the basis for searching for candidate genes of monogenic and multifactorial diseases, including type 1 and 2 diabetes mellitus, coronary heart disease, obesity, vascular diseases, and others. To date, approximately 40 loci associated with type 2 diabetes mellitus (T2DM) have been identified and genetic predisposition factors for cardiovascular diseases have been determined. In some cases, the GWAS results not only enable understanding of the pathophysiologic basis for diseases, but also may give rise to new drugs. However, the question naturally arises about the possibility of implementing the accumulated knowledge to predict the development of diseases, including T2DM and its vascular complications. This review summarises the literature data on the possibilities to use the GWAS results to calculate the risk of developing diabetes and cardiovascular diseases. Determination of the individual genetic risk will allow for the primary prevention of diseases and will apparently be the basis of personalised predictive medicine in the near future.

Aims. To determine the incidence and risk factors for hypoglycemia in elderly insulin-treated type 2 diabetes mellitus (T2DM) patients by means of continuous glucose monitoring (CGM). Materials and Methods. We observed seventy-six hospitalized patients with T2DM, aged 65 to 79 years. Treatment with basal insulin (n=36), premixed insulin (n=12) or basal-bolus insulin regimen (n=28) was followed by metformin (n=44), glimepiride (n=14) and dipeptidyl peptidase-4 inhibitors (n=14). 2-days CGM with retrospective data analysis was performed in all patients. During CGM, three fasting and three 2-h postprandial finger-prick glucose values were obtained daily with portable glucose meter. Results. Hypoglycemia (identified as blood glucose

Цель. Изучение фактической распространенности осложнений СД и оценка качества помощи больным в Российской Федерации. Материалы и методы. бъектом исследования была случайная выборка больных СД в 16 регионах Северо-Западного, Приволжского, Южного и Сибирского федеральных округов. Общее число обследованных составило 8502 больных СД 1 и 2 типа. Программа исследования включала изучение состояния органов зрения, периферической нервной системы, почек, нижних конечностей и сердечно-сосудистой системы. Проводилось определение гликемии, НЬА1с, альбуминурии, креатинина (их соотношения), общего холестерина и триглицеридов. Результаты. Установлено, что реальная распространенность таких осложнений СД, как диабетическая катаракта, ретинопатия, нефропатия, сенсорная полинейропатия, ИБС и артериальная гипертония значительно превышают регистрируемую. По данным скрининга средние значения распространенности МАУ у детей с СД 1 типа составили 12,06+0,14%, у подростков ? 37,68+0,16%, у взрослых ? 27,98+0,09%, у взрослых с СД 2 типа ? 34,46+0,15%. Средние значения распространенности ДН среди взрослых больных СД 2 типа по данным скрининга в 3,4 раза превышают аналогичный показатель по данным регистра регионов. у взрослых больных СД 1 типа средний уровень распространенности ДНП по данным скрининга был выше данных регистра на 30,5%. Доля больных с уровнем НЬА1с 8,0% и более у детей с СД1 типа составит 70,18%, у подростков ? 81,1%, у взрослых ? 72,0%, у взрослых больных с СД2 типа ? 57,14%. Выводы. Результаты проведенного скрининга в 16 регионах РФ позволили установить, что фактическая распространенность основных осложнений СД у больных СД 1 и 2 типа на 20?50% выше регистрируемой, в связи с чем необходимо разработать меры по их более полному выявлению на ранних стадиях. Подавляющее число больных СД находится в состоянии хронической декомпенсации, которая достигает 85,5% у детей, 92,6% у подростков, 83,9% у взрослых больных СД 1 типа и 74,8% ? у больных СД 2 типа, что требует от врачей более настойчивых усилий при достижении целевых уровней компенсации углеводного обмена. Средний уровень НЬА1с у больных СД в сельской местности на 33,7?42,1% выше, чем у жителей региональных центров. Необходимо существенное увеличение экономической, материальнотехнической и кадровой базы специализированной помощи этой категории больных.

В соответствии с современными тенденциями мировой диабетологии принято, что больные сахарным диабетом (СД) должны быть под наблюдением группы специалистов при координации всего лечебного процесса врачом-диабетологом. В состав такой команды? помимо врача включается медицинская сестра, врач по лечебному питанию или специально обученная медицинская сестра и психолог. В случае необходимости для консультации привлекаются соответствующие узкие? специалисты. Такой интегрированный подход имеет свои преимущества, больному при этом отводится активная роль в лечении.

Цель. Анализ риска развития СД 1 типа в популяции башкир, связанного с наличием предрасполагающих и протективных аллелей DQA1 и DQB1 генов HLA-системы. Материалы и методы. Работа проводилась в рамках Федеральной целевой программы ?Сахарный диабет? и является фрагментом проекта ?Скрининг осложнений сахарного диабета и оценка эффективности лечебной помощи больным?, проводимого совместно с фирмой ново Нордиск? (Дания). Обследована этническая группа башкир, больных СД 1 типа, которая включала 37 детей и 13 взрослых, из них мужчин ? 21, женщин ? 29. Контрольная группа башкир составила 57 человек. Средний возраст в группе обследования и контрольной группе не различался. Идентификация национальной принадлежности проводилась путем изучения родословной. HLA генотипирование проводили методом мультипраймерной полимеразной цепной реакции по трем генам DRB1, DQA1, DQB1. Результаты. При сравнительном анализе распространенности DRB1 аллелей среди башкир установлено, что ее значения достоверно выше у больных СД 1 типа, чем в группе контроля без диабета, для DRB1*17(03) и DRB1*04. По результатам сравнительного анализа DQA1 аллелей высокие показатели распространенности среди башкир, больных СД 1 типа, имели DQA1*0301 (64% у больных и 17,5% в группе контроля) и DQA1*0501 (60% у больных, в группе контроля 38,6%). При сравнительном анализе DQB1 аллелей в популяции башкир наблюдались значительные различия в показателях распространенности аллелей DQB1*0201, DQB1*0301, DQB1*0302, DQB1*0602-8. Сравнительный анализ показателей распространенности гаплотипов HLA DQA1 ? DQB1 в популяции башкир показал, что достоверно выше ее значения в группе больных СД 1 типа, чем в группе контроля для HLA DQA1*0301 ? DQB1*0302 и DQA1*0501 ? DQB1*0201. Выводы. Генотипирование аллелей HLA ? DRB1, HLA ? DQA1, HLA ? DQB1 в популяции башкир, больных СД 1 типа, и лиц без диабета позволило установить их значимость в отношении риска заболевания в этой этнической группе. Достоверно более высокий риск развития СД 1 типа у башкир, как и в других этнических группах, ассоциирован с аллелями DRB1*04, DQA1*0301, DQB1*0302. Выявлены некоторые особенности в отношении аллеля DQA1*0201, который в популяции бурят обладает предрасполагающим характером, повышая риск развития СД 1 типа; у башкир аналогичных данных не получено. Среди гаплотипов у башкир выявлены те же маркеры риска развития СД 1 типа, что и в других этнических группах. Наиболее высокий риск развития СД 1 типа в популяции башкир определяется гаплотипами DQA1*0301 ? DQB1*0302, DRB1*04 ? DQB1*0302 и DRB1*04 ? DQA1*0301 ? DQB1*0302. Башкиры в отличие от русских имеют достоверно более высокий риск развития СД 1 типа при наличии классических? гаплотипов: DRB1*17(03) ? DQA1*0501, DRB1*17(03) ? DQB1*0201, DQA1*0501 ? DQB1*0201.

Необходимо оказать дополнительное внимание региональным территориальным отделам здравоохранения по дальнейшей организации работы отделений Государственного регистра больных сахарным диабетом. Это стало особенно актуальным после введения системы льготного обеспечения лекарствами больных сахарным диабетом. Выделение дополнительного финансирования на эти цели не только быстро окупится, но и будет сопровождаться значительной экономией средств, затрачиваемых на лечение сосудистых осложнений диабета. Доказано, что своевременное лечение и контроль диабета способствуют снижению частоты сосудистых осложнений, сохранению трудоспособности больных, приводя к значительному уменьшению в последующие годы расходов на поддержание соответствующего качества жизни.

Цель. Оценить только прямые расходы на лечение СД и его осложнений и на их основе, используя общепринятые модели прогноза, оценить экономический эффект от применения современных методов лечения. Материалы и методы. На первом этапе была обследована случайная выборка из 500 больных СД в 15 регионах Российской Федерации. Стоимость простых медицинских услуг определялись согласно ?Тарифам на медицинские услуги?, предоставляемыми взрослому населению в соответствии с тарифами региональных ОМС. На втором этапе на основе модели прогноза осложнений СД Diabetes Mellitus Model (DMM) и данных ГРСД, а также стоимости лечения осложнений сахарного диабета была определена прогнозирумая распространенность осложнений СД и ежегодные затраты на лечение 1 больного. На третьем этапе на основе данных Государственного регистра больных сахарным диабетом России была рассчитана общая стоимость лечения больных СД в России на момент исследования и на 10-летний период от начала исследования при условии, что средний уровень НЬА1с снизится всего лишь на 1,0%. Результаты. Расчеты расходов на лечение больных СД в 2003 г. включают все осложнения диабета, в том числе диабетическую и гипогликемическую кому, синдром диабетической стопы?, хроническую сердечно-сосудистую и почечную недостаточность и некоторые другие. На офтальмологическую помощь больному с начальной ретинопатией расходуется в среднем 68,6 $ в год, с тяжелой пролиферативной формой ? 1030,0 $, т.е. в 15 раз больше. На лечение больного с нефропатией в начальной стадии расходуется 245,0 $ в год, с хронической почечной недостаточностью (ХПН ) ? 2012,0 $ без учета расходов на гемодиализ, трансплантацию почки и т.п. Выводы. Сахарный диабет ? заболевание , требующее значительных затрат. Однако как прямые , так и косвенные расходы могут быть снижены за счет ранней диагностики СД и его осложнений, внедрения новых технологий их лечения , более эффективной профилактик и СД и его осложнений. Внедрение в повседневную практику обязательного определения гликемии, использование современных инсулинов и сахароснижающих таблетированных препаратов, постепенный переход от стационарного преимущественно к амбулаторному лечению, улучшение метаболического контроля , расширение сети школ по обучению больных и повышение эффективности их работы позволят существенно снизит ь расходы на диабетическую помощь. Следует иметь в виду, что начальное удорожание диабетической помощи обязательно компенсируется значительным снижением затрат в будущем.

На протяжении десятилетий проводятся исследования, направленные на возможность замещения у больных СД типа 1 утраченной функци и островков поджелудочной железы, восстановления функции инсулярного аппарата поджелудочной железы и нормальной регуляции углеводного обмена. Научные исследования проводятся по нескольким направлениям: аллогенная трансплантация поджелудочной железы или ее фрагментов; пересадка островко в поджелудочной железы, полученных от аллогенного или ксеногенного донора; разработка и создание искусственной поджелудочной железы.

Цель. Изучение уровня TGFbl и bFGF у пациентов с высоким коронарным риском (20-40%) по Coronary Risk Chart for Primary Prevention (European and other Societies on Coronary Prevention) с СД типа 2 и без СД типа 2 в сравнении с группой здоровых лиц и выявление возможной взаимосвязи между этими факторами роста и метаболическими показателями (ИМТ, уровень холестерина, HbAlc и др.). Материалы и методы. В исследование был включен 81 пациент. Все пациенты распределены на 3 группы, основным критерием отбора служил коронарный риск (20-40% и

Цель. Оценка эффективности и безопасности пиоглитазона гидрохлорида (ПИО) в качестве монотерапии и в комбинации с ПСП (сульфонилмочевина или метформин) у пациентов с СД типа 2 по изменению уровней гликированного гемоглобина HbAlc (первичный параметр эффективности) и глюкозы плазмы натощак (ГПН, вторичный параметр эффективности). Материалы и методы. В исследование было включено 85 пациентов: в группу монотерапии ? 30 (35,3%) пациентов, в группу комбинированной терапии ? 55 (64,7%) пациентов. Для анализа эффективности использовали данные пациентов, которые приняли хотя бы одну дозу исследуемого препарата и имели хотя бы одну оценку эффективности (HbAlc) после исходного уровня. Кроме того, был подсчитан процент больных, достигших различных уровней гликемического контроля: 1-й ? НЬА1с9%. Результаты. После 3-месячной терапии ПИО было зарегистрировано улучшение показателей гликемического контроля во всех группах терапии. После проведенной терапии ПИО в течение 3 месяцев достигли хорошего гликемического контроля (HbAlc

Цель. Изучение влияния формина (метформина) не только на состояние углеводного, но и липидного обмена, динамику содержания лептина, его растворимого рецептора и альфа-фактора некроза опухолей (альфа-ФНО) в сыворотке крови у больных СД 2. Материалы и методы. Обследовано 262 больных. Общий анализ крови и мочи проводили через каждый месяц наблюдения, а биохимический анализ крови, включая содержание общего ХС, ТГ, ХС ЛПНП и ЛПОНП и ХС ЛПВП, мочевины, креатинина, печеночных ферментов, проводили на 1-м и 4-м визитах. Лечение формином проводилось в течение не менее 12 нед. и изучалось при этом его влияние на состояние углеводного и липидного обмена у больных СД 2. Из общего числа обследованных у 26 больных на фоне терапии формином изучалось содержание лептина, растворимого рецептора к лептину и альфа-ФНО. Результаты. На фоне лечения формином у больных отмечалось улучшение углеводного обмена, которое сопровождалось статистически достоверным снижением гликемии натощак. Компенсация углеводного обмена у больных также сопровождалась статистически достоверным уменьшением индекса мас? сы тела с 34,02+0,33 кг/м2 до 32,73+0,33 кг/м2. У больных на фоне лечения формином наблюдается недостоверное снижение содержания лептина, растворимого рецептора к лептину и статистически достоверное снижение альфа-ФНО в сыворотке крови. Выводы. проведенные исследования показывают, что формин обладает выраженным антигипергликемическим эффектом, способствует улучшению компенсации углеводного обмена, что сопровождается статистически достоверным снижением гликемии и уровня гликозилированного гемоглобина в сыворотке крови. Наряду с этим на фоне терапии формином отмечается снижение уровня холестерина ЛПНП и повышение содержания холестерина ЛПВП, при практически неизмененных показателях содержания общего холестерина в сыворотке крови. Кроме того, лечение формином способствует статистически достоверному снижению содержания альфа-ФНО и умеренному понижению уровня лептина и его растворимого рецептора в сыворотке крови.

На протяжении десятилетий проводятся исследования, направленные на возможность замещения утраченной функции островков поджелудочной железы, восстановления функции инсулярного аппарата поджелудочной железы и нормальной регуляции углеводного обмена. Научные исследования проводятся по нескольким направлениям: аллогенная трансплантация поджелудочной железы или ее фрагментов; пересадка островков поджелудочной железы, полученных от аллогенного или ксеногенного донора; разработка и создание искусственной поджелудочной железы.

Цель. Изучение фактической распространенности осложнений СД и оценка качества помощи больным в ряде регионов России. Материалы и методы. Обследована выборка 730 больных, которая включала детей, подростков и взрослых. Программа обследования включала физикальное обследование больного, изучение состояния органов зрения, сердечно-сосудистой системы, почек, нижних конечностей. Состояние углеводного обмена оценивалось по уровню НвА1с, функция почек ? по уровню креатинина, мочевины в крови, наличию микроальбуминурии и протеинурии; липидного обмена - по уровню общего холестерина и триглицеридов. Результаты. Показатели фактической распространенности диабетической нефропатии среди больных СД 2 типа значительно превышали регистрируемую у мужчин в 5 раз, у женщин в 3 раза. При 1 типе СД фактиче? ская распространенность диабетической катаракты, полинейропатии превышает регистрируемую в 2 раза, диабетической стопы на ? 30%, артериальной гипертонии в 2,5 раза. Значительную долю (11,34%) составляют больные с тяжелыми исходами сосудистых осложнений: слепота у больных с 1 типом СД достигает 2,47%, нарушение мозгового кровообращения у больных с СД 2 типа ? 8,9%. У детей с длительностью СД типа 1 не более 2 лет дислипопротеидемия наблюдается у 2,2%, среди подростков ? 9,2%, а у взрослых со СД типа 2 ? 39,2%. Выводы. Состояние лечебно-профилактической помощи в республике Татарстан требует принятия дополнительных мер по организации и развитию диабетологической помощи. Число больных, находящихся в состоянии хронической декомпенсации диабета, составляет от 18,1% у детей и взрослых до 41,5% у подростков. В целом по республике больные не получают в достаточном объеме помощи таких специалистов, как офтальмолог, кардиолог, невропатолог, нефролог и специалист по диабетической стопе?. В лечении больных СД типа 2 необходимо шире использовать инсулинотерапию.

Aim. To assess the extent of the lower limb arterial calcification and to evaluate the long-term outcomes of percutaneous transluminal balloon angioplasty (PTBA) in patients with diabetes mellitus (DM), critical limb ischemia (CLI) and chronic kidney disease (CKD). Materials and Methods. 94 patients with CLI formed two groups (CKD-positive and CDK-negative). Quantitative assessment of tibial arterial calcification was performed with non-contrast CT. Outcomes of angioplasty were monitored during the 18?6 months of the follow-up period by means of duplex ultrasonography. Results. Long-term outcomes of PTBA were significantly worse in patients with CKD. Nevertheless, limb preservation and survival rates were relatively satisfactory in both groups (74% and 72%, respectively). Conclusion. PTBA in patients with DM, CLI and CKD presents a technical challenge. Despite that, in many cases the endovascular intervention allows avoiding high-level amputations and improves survival rates.

Aim. To estimate the prevalence of type 2 diabetes mellitus (T2DM) among the population of Moscow Region, as well as the actual prevalence of diabetes complications in individuals already diagnosed with DM. Materials and Methods. 2403 inhabitants of Stupinksy and Domodedovsky areas aged 30 to 70 years were selected by means of random sampling for the estimation of T2DM prevalence. Another 600 individuals inhabiting Pushkinsky and Serpukhovsky areas were randomly selected for the estimation of the prevalence of DM complications (including patients with T2DM). Clinical screening was performed by the mobile diagnostic team. Results. HbA1c level was tested in all participants. The cut-off point for the diagnosis of DM was set for . HbA1c>6.5% according to the WHO guidelines (2011). 204 individuals (8.49%) met this criterion and were selected for further evaluation by OGTT with the following Results. 28.04% were positive for glycemic disorders, including T2DM (8.53%), IGT (17.07%), IFG (2.44%). The highest prevalence of T2DM was found in the elder group (60?70 years old). The prevalence of diabetic retinopathy was estimated at 26.06%, being 2 times higher among T2DM patients than previously calculated for Moscow Region by the Russian State Diabetes Register (13.2%). The microalbuminuria stage of diabetic nephropathy was diagnosed in 46.1% of diabetes patients, being 5 times more prevalent than previously estimated for Moscow Region by the Russian State Diabetes Register (5.84%). Conclusion. The actual prevalence of T2DM in Moscow Region is markedly higher than the registered. The prevalence of diabetes complications is also significantly underestimated. Most patients do not achieve . HbA1c targets (

Diabetic foot syndrome (DFS) is one of the most prevalent and financially demanding complications of diabetes mellitus (DM). According to a number of expert analyses, DFS counts for 15% to 25% of total diabetes spendings by the developed economies. The Advanced Medical Care Program in Russian Federation covers expanses for patients with DFS. However, DFS patient profile has no dedicated budgeting quotation as yet, and that of ?general endocrinology? does not meet specific clinical requirements. An expenditure analysis was performed to facilitate the development of budgetary recommendations. The survey included two major steps: a systematic analysis of the data available from periodic literature, followed by an assessment of routine clinical practice in a federal healthcare institution (using the example of Moscow Endocrinology Research Centre).