DECLARE-TIMI 58 trial in the context of EMPA-REG OUTCOME and CANVAS

The article discussed results of the DECLARE-TIMI 58 study in the aspects of the previously finished trials (EMPA-REG OUTCOME and CANVAS). All three SGLT2i demonstrated the reduction of the risk of hospitalization for heart failure, as well as the risk of progression chronic kidney disease. At the same time, the patient populations are different. In EMPA-REG OUTCOME almost all the patients had previously diagnosed cardiovascular disease; in CANVAS 44.4% of patients did not have a confirmed cardiovascular disease, but had cardiovascular risk factors, and in DECLARE TIMI 58 there were 59% of such patients. Assessment of the published data suggests that the risk of a combined cardiovascular endpoint, including death from cardiovascular causes, myocardial infarction, and stroke, seems to be most pronounced in patients who already have established cardiovascular disease, and this effect is achieved mainly by reducing cardiovascular mortality. In the population of patients with type 2 diabetes who do not have cardiovascular disease, but who have cardiovascular risk factors, this effect is not detected. Contrary, risk-reduction of hospitalization for CHF and slowing the progression of CKD is manifested both in a population of patients with established cardiovascular disease and in the population of patients with multiple cardiovascular risk factors. In this regard, DECLARE-TIMI 58, as well as previously published data, open up new option for an earlier start of SGLT-2i for primary prevention and/or slowing the progression of nephropathy, reducing the risk of heart failure, and its prevention, as well as reduction of cardiovascular morbidity and mortality in patients with type 2 diabetes, regardless of the presence or absence of cardiovascular pathology in the anamnesis

Vascular complications of diabetes mellitus worldwide and in Russia: The path of 100 years. A review

With the discovery and introduction of insulin, the "palette" of life-threatening conditions for patients with diabetes mellitus has changed dramatically: from diabetic coma of the "pre-insulin era" to severe vascular complications in the modern period. The key risk factors for diabetic angiopathies in diabetes mellitus are poor glycemic control in combination with a long course of the disease. Over the past 30 years, there has been a downward trend in the incidence of late vascular complications of diabetes both worldwide and in Russia. In particular, the frequency of cardiovascular events (myocardial infarctions, strokes, amputations) decreased, and the incidence of several other complications, such as diabetic retinopathy and neuropathy, stabilized. However, the incidence of chronic kidney disease and chronic heart failure is still increasing. The Joslin Medal, awarded to patients over 50, 75 and even 80 years of life with diabetes, reflects success in the fight against this disease

Review of the results of the EASYDia international observational study. The effect of dose titration of diabeton MR on the effectiveness of treatment of type 2 diabetes

Although the number of antihyperglycemic agents has expanded significantly, sulfonylureas (in particular gliclazide MR) remain an important option in the treatment algorithms of type 2 diabetes mellitus (DM2). A large observational international study EASYDia in real clinical practice, assessing effectiveness of gliclazide MR 60 mg in patients with long-term DM2 on standard glucose-lowering therapy, showed that step-by-step intensification of therapy with gliclazide MR 60mg allows to achieve and maintain the target values of glycemia, with good tolerability even in maximum doses, low risk of hypoglycemia and no weight gain

The new views on the state of the gut microbiota in obesity and diabetes mellitus type 2

Obesity is a worldwide problem of the last century, the prevalence of which has reached pandemic proportions in developed countries. Over the past few years, a considerable amount of data has been gathered, reporting a direct link between changes in gut microbiota and the development of obesity, as well as related diseases, primarily, diabetes mellitus type 2. The elaboration of optimal methods of prevention and treatment regimens of these diseases needs to structure the existing knowledge about the mechanisms of development of metabolic disorders, the role of intestinal microbiota in the latter and possible therapeutic “targets”. This review examines the role of microorganisms in the human body, with the main focus on the developmental origins of metabolic disorders using animal models and accumulated experience of research on their effects on the human body, and also discusses possible treatment options, including bariatric surgery, fecal microbiota transplantation, the use of pre- and probiotics and certain particular groups of glucose-lowering drugs

The clinical and epidemiological characteristics of hypogonadism in men with type 2 diabetes mellitus

BACKGROUND: Male hypogonadism is a frequent complication of diabetes mellitus (DM) type 2; therefore, a study of its clinical and epidemiological characteristics is of interest. AIMS: Assessment of clinical and epidemiological characteristics of hypogonadism in men with diabetes mellitus type 2. METHODS: A full-design, cross-sectional, screening, multicenter, non-interventional study included men with diabetes mellitus type 2. The study was conducted from November 2017 to January 2019.Medical history assessment, sexological testing, estimation of luteinizing hormone (LH), sex hormone-binding globulin; total testosterone and glycated hemoglobin were performed. Free testosterone was calculated by the Vermeullen method. Comparison of groups was carried out using Yates’s corrected version of chi-squared test, Mann-Whitney U-test, and Spearman’s rank correlation method was also used. Differences were considered statistically significant with p <0,05. RESULTS: The age of 554 men included in the study was 55 [50; 58] years, total testosterone level was 12,5 [9,1; 16,4] nmol/L; free testosterone was 0,266 [0,205; 0,333] nmol/L; HbA1c 7,2 [6,2; 8,9] %. Hypogonadism syndrome was detected in 181 men (32,7%). Total testosterone level in these patients was 7,8 [6,5; 9,4] nmol/L, and free testosterone level was 0,182 [0,152; 0,217] nmol/L. In patients without hypogonadism, these parameters were 14,7 [12,4; 18,0] nmol/L and 0,308 [0,265; 0,362] nmol/L, respectively. In most cases, patients with hypogonadism had normal, but lower LH levels of 3,3 [2,2; 4,9] U/L compared with patients without hypogonadism 3,8 [2,7; 4,9], p = 0,022. Most often, normogonadotropic hypogonadism was detected (89,5%). Statistically significant negative correlations were found between total testosterone levels and body mass index (r = -0,24; p <0,001), and waist circumference (r = -0,21; p<0,001). The prevalence of decreased libido in patients with hypogonadism (66,8%) is statistically significantly higher than that in men without hypogonadism (56,3%, p = 0,022). CONCLUSIONS: The prevalence of hypogonadism syndrome in men with diabetes mellitus type 2 is 32,7%. This type of hypogonadism is characterized by normal LH values

The prevalence of hypogonadism in men with type 2 diabetes mellitus in clinical practice

BACKGROUND: Hypogonadism is a common complication in men with type 2 diabetes mellitus (DM), but its prevalence remains unknown. AIMS: To estimate the prevalence of hypogonadism in men with type 2 DM. MATERIALS AND METHODS: Male patients with type 2 DM were enrolled into a single-cohort contemporaneous multicenter non-interventional screening study. The study period was from November 2017 through August 2018. Assessments included total testosterone, luteinizing hormone (LH), sex hormone-binding globulin, HbA1c levels. Levels of free testosterone were calculated by Vermeullen method. RESULTS: TheThe median of age of 400 included men was 56 years [51; 58], total testosterone was 12.3 [9.2; 16.5] nmol/l, free testosterone – 270 [217; 334] pmol/l, HbA1c – 7,1% [6.1; 8.6]. Hypogonadism was found in 135 men (33.7%). The total testosterone level in that group was 7.9 [6.8; 9.8] nmol/l, and free testosterone – 192 [164; 227] pmol/l. In hypogonadism-free men their levels were 15,1 [12,4; 18,6] nmol/l and 311 [270; 364] pmol/l, respectively. In most patients with hypogonadism LH level was low, but within normal ranges, and significantly lower than in men without hypogonadism – 3.2 [2.1; 4.7] IU/L vs 3.8 [2.7; 4.9] IU/L, respectively (p=0.007). Most commonly hypogonadism was with normal LH levels (92,6%, median LH level 3.2 [2.2; 4.3] IU/L, p<0,001). The frequency of hypogonadism with high LH level (10.2 [9.2; 14.7] IU/L) and low LH level (1.0 [0.6; 1.1] IU/L) was 4.4% and 3.0%, respectively. CONCLUSIONS: The prevalence of hypogonadism in men with type 2 DM was found to be 33.7%. Normal levels of LH are typical for this type of patients with hypogonadism

Corrigendum: The new views on the state of the gut microbiota in obesity and diabetes mellitus type 2 (Diabetes mellitus. 2019;22(3). doi: 10.14341/DM10194)

A corrigendum on «The new views on the state of the gut microbiota in obesity and diabetes mellitus type 2» by Elena V. Pokrovskaya, Minara S. Shamkhalova, Marina V. Shestakova (2019). Diabetes Mellitus. 22(3). doi: 10.14341/DM10194There is an error on the page 255: "Moreover, in obese patients, the concentration of circulating LPS increases by 20%, and in patients with diabetes mellitus, it increases by 125%. LPS is transported from cells of the large intestine into the bloodstream through chylomicrons or through intercellular gaps in the intestinal wall; by forming a complex of CD14 with Toll-like receptor 4 of macrophages and endothelial cells, it causes the release of anti-inflammatory cytokines: namely, interleukin-1, interleukin-6 and tumour necrosis factor alpha ". Instead of " pro-inflammatory cytokines" was published " anti-inflammatory cytokines ".Literary source «Dahiya DK, Renuka, Puniya M, et al. Gut Microbiota Modulation and Its Relationship with Obesity Using Prebiotic Fibers and Probiotics: A Review. Front Microbiol. 2017;8:563. doi: https://doi.org/10.3389/fmicb.2017.00563» is listed twice (№№ 7 and 13) in the list of references.The authors apologize for this error and state that this does not change the scientific conclusions of the article in any way.The original article has been updated

Identifying the unmet needs of individuals with Type 2 diabetes: an international web-based survey

Aim: To identify and understand the main unmet needs of individuals with Type 2 diabetes (T2D). Materials & methods: An online survey was conducted in Brazil, China and Russia of individuals with recently diagnosed T2D. Results: The survey, involving 300 individuals with T2D, identified a need for more information regarding food/diet and for increased awareness of T2D symptoms. While most participants (94%) had experienced symptoms prior to their diagnosis, only 55% of symptomatic individuals sought medical attention. Conclusion: Novel strategies to increase awareness of diabetes should be developed and tested, and may enable earlier diagnosis and improve patients' quality of life.publishersversionpublishe

The effect of bariatric surgery on purine metabolism and gout

Gout is an auto-inflammatory tophaceous disease characterized by the deposition of crystals of monosodium urate and developing in connection with this inflammation in people with hyperuricemia (HU). Except to genetic factors, risk factors for the development of HU and gout are many modifiable factors, including metabolic syndrome and obesity, and their correction is the most important component of successful disease control. Obesity can change the clinical picture of gout, characterized by an earlier onset, a large number of affected joints. Weight loss helps reduce uric acid (UA) serum levels. Bariatric / metabolic surgery significantly reduces the incidence of comorbid obesity and mortality, and is by far the most effective way to combat obesity. In addition to improving health, an important goal of bariatric surgery is to improve the quality of life. Bariatric surgery can prevent the development of HU in subjects with an initially normal level of serum UA before surgery. The dynamics of the concentration of UA in serum can be a predictor of successful bariatric surgery and help in predicting the severity of postoperative weight loss. The decrease in body weight after bariatric surgery leads to a decrease in UA in the long-term postoperative period, however, there is a high frequency of acute gout attacks in the early postoperative period. Thus, bariatric surgery has a significant effect on HU and gout and can be an effective treatment for this disease

Rational approach to patients treatment with type 2 diabetes and obesity: results of the All-Russian observational program «AURORA»

Background: As in many other developed nations, the problem of obesity and type 2 diabetes is acute in Russia. In Russia, the only combination of sibutramine and metformine (Reduxin®Met) is authorized to reduce body mass and prevention development of type 2 diabetes mellitus or its complication. The article presents the results of the observational program “AVRORA”. Aim: Evaluation of the effectiveness and safety of Reduxin®Met (sibutramine + microcrystalline cellulose + Metformin) in patients with type 2 diabetes and alimentary obesity in routine clinical practice. Materials & methods: The observational program “AVRORA” was conducted from September 2016 to October 2017 under the auspices of the Endocrinological Scientific Center and the Russian Association of Endocrinologists. The “AVRORA” program was a multicenter, non-interventional study of patients to whom the attending physicians prescribed Reduxin®Met, a set (tablets + capsules), in accordance with the instruction for medical use as part of routine clinical practice. The treated group included patients of both sexes, aged 18–65 years, with an established diagnosis of obesity in combination with type 2 diabetes. The duration of the drug usage was determined by the attending physician and was up to 6 months. Reduxine®Met was prescribed in addition to the existing glucose-lowering therapy, the dose of metformin was adjusted to the patient's needs. Results: The “AVRORA” study was attended by 259 doctors and 5,812 patients in 240 medical institutions from 12 cities of the Russian Federation. The average age of patients was 46.6 ± 10.5 years, the ratio of male / female -24% / 76%. The decreasing of BMI during 6 months of the therapy amounted to 5.4 ± 2.3 kg / m2 (on average, 15.1 ± 6.4 kg). After 3 months of the therapy 81.6% of patients achieved clinically significant weight loss of 10.6% or more. The average decrease in waist circumference during 6 months of therapy was 13.8 ± 7.4 cm. A decrease of indicators of glycemic control and lipid metabolism right up to the target values was observed. Conclusions: In “AVRORA” study it was shown that addition of Reduxine®Met (sibutramine+ microcrystalline cellulose+metformine) to the complex therapy of the diabetes in combination with obesity according to approved indications is safe and effective for long-term treatment in regards to weight loss, regulation of lipemic index, glucose profile and quality of life