Quality of ejaculate of male patients with type 2 diabetes mellitus (DM), vaccinated with GamCovidVac (Sputnik V)

Background: New coronavirus infection (Covid-19) in patients with diabetes type 2 mellitus (DM) often has severe clinical course and manifestation. This comorbidity is a reasonable indication for vaccination. Male patients are often concerned about the vaccination impact on their fertility, so the current research of this issue seems to be essential and relevant.Aims: To evaluate the quality of ejaculate in type 2 diabetes mellitus (DM) patients, vaccinated by GamCovidVac (Sputnik V).Materials and Methods: The pilot observational prospective study included 30 males with type 2 diabetes mellitus (DM). The study continued from February 2021 till June 2021. The research design involved medical history analysis, glycated hemoglobin (HbA1c) tests, total testosterone level in blood measurement, semen analysis (sperm count test). Group comparison was performed by Wilcoxon Signed Ranks Test. The differences were considered statistically significant at p<0.05.Results: After vaccination 19 patients (63%) demonstrated a temperature rise which lasted for 2 days; 26 patients (87%) complained of tenderness in the injections site which lasted up to 5 days. Though a few patients reported general somatic side effects after the vaccination, there have been no statistically significant deviations in sperm count, viability, function and morphology. The levels of glycated hemoglobin and total testosterone remained unchanged.Conclusion: The study revealed no negative impact of GamCovidVac on ejaculate quality, total testosterone level and compensation of carbohydrate metabolism

Semen quality indicators associated with reduced body weight in young infertile men with pathozoospermia, postpubertal visceral obesity and normal andrological history

Background: Considering the negative impact of visceral obesity on fertility, it is important to study semen quality indicators associated with reduced body weight.Aims: Evaluation of semen quality indicators associated with reduced body weight in patients with infertility, postpubertal visceral obesity and normal andrological history.Materials and methods: 33 infertile men under 30 years with post-pubertal and alimentary visceral obesity were included into retrospective case-control study. All patients have been followed through a six month weight loss program (hypocaloric diet, daily aerobic physical activity). The waist circumference, blood lipid levels, seminal antioxidant capacity and scanning electron microscopy analysis were determined before and after weight loss program. At the end of the study, patients were divided into two groups according to weight loss. The first group reduced their body weight by 5% or more (n=16), second group didn’t achieve the goal (n=17).Results: Statistically significant differences were identified in the ejaculate parameters between patients of two groups. Though at the time of initiation of medical intervention two groups were comparable except for body mass, after six months in the first group the number of sperm in 1 ml ejaculate, morphologically normal forms and the total antioxidant capacity of ejaculate increased while the number of sperm DNA integrity decreased.Conclusion: In young men with postpubertal visceral obesity and normal andrological history clinically significant body weight reduction is associated with improved semen quality indicators

Ejaculate quality indicators of men with asthenozoospermia and asthenoteratozoospermia by treatment of obesity with liraglutide

Background: Considering the influence of visceral obesity on male infertility, the investigation of ejaculate quality indicators under obesity treatment is relevant.Objective: Evaluation of ejaculate quality indicators by obesity treatment with liraglutide in andrologically healthy men with infertility and post-pubertal visceral obesity.Methods: Infertile men with post-pubertal alimentary visceral obesity were included in a pilot observational prospective study. All patients were given recommendations for body weight loss (hypocaloric diet, daily aerobic physical activity) as well as an average daily dose of liraglutide 2.4 [2.4; 3.0] mg. Evaluation of waist circumference, antioxidant activity of ejaculate, spermogram was carried out initially and after 6 months. The differences were considered statistically significant at p <0.005.Results: The body weight decrease was -11.7 [12.4; 11.0]%, the waist circumference decrease was 8 [12; 7] cm. In dynamics, increased content of living sperm in ejaculate from 92 [90; 95]% to 95 [92; 98]%, morphologically normal forms from 5 [3; 6]% to 6 [3; 8]%, mobility of A + B from 25 [15; 36] to 35 [19; 52]%, seminal antioxidant capacity, a decrease in reactive oxygen forms in the neat ejaculate were statistically significant. Increasing the sperm count in 1 ml and decreasing reactive oxygen forms in the washed ejaculate did not reach statistical significance.Conclusion: Ejaculate quality indicators improved by the complex obesity therapy with liraglutide in young andrologically healthy men with postpubertal visceral obesity

Stimulation of spermatogenesis by combined therapy with follicle-stimulating hormone and chorionic gonadotropin for azoospermia and infertility in cases of previous ineffective monotherapy with chorionic gonadotropin and antiestrogen

Often there is a need of application of the methods of treatment, directed on increase in quantity of spermatozoa in an ejaculate. In the research efficiency of the combined therapy by preparation follicle-stimulating hormone was estimated and a chorionic gonadotrophin in cases of the previous inefficiency monotherapy a chorionic gonadotrophin and an anti-estrogen. The efficiency of treatment concerning an oligoteratozoospermiya made 65 %. Positive changes of morphology of spermatozoa included improvement of condensation of a chromatin and decrease of the degrading forms. At the same time this treatment was safe and didn»t lead to development of side effects

The incidence and aggravating factors of male hypogonadism in type 2 diabetes

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 diabetesMATERIALS 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

Clinical and epidemiological characteristics of male hypogonadism in type 2 diabetes in Russia: combined analysis of study data for the period 2005–2022

Background: Male hypogonadism is associated with type 2 diabetes mellitus (T2DM), therefore, it is of interest to study its clinical and epidemiological characteristics. These data are published, but their fragmentation and small sample sizes are a problem. A summary assessment of the combined primary data of the conducted studies will provide sufficient representativeness and will allow to extrapolate the results to the general Russian population with T2DM.Aim: Assessment of the clinical and epidemiological characteristics and aggravating factors of male hypogonadism in T2DM in Russia.Materials and methods: A Combining primary data (anamnesis, anthropometric indicators, laboratory tests) of full-design, cross-sectional, screening studies of hypogonadism in men with T2DM conducted on the territory of the Russian Federation in the period from 2005 to 2022. 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 p <0,05. The groups were compared using the Mann-Whitney U-test and χ² with Yates correction. Differences were considered statistically significant at p<0.05.Results: Hypogonadism was detected in 893 of 1576 men (56,7%) with T2DM. Patients with hypogonadism were statistically significantly older, had higher body mass index (BMI), worse glycemic control than eugonadal men. There was ­statistically significantly higher prevalence of macroangiopathies and polyneuropathy in hypogonadal patients.Conclusion: The prevalence of male hypogonadism in T2DM 56,7%. Its development is due to age, obesity, worse glycemic control. Hypogonadism syndrome is associated with the development of diabetic macroangiopathy and polyneuropathy. Severe violation of glycemic control (glycated hemoglobin (HbA1c) 10% or more) significantly reduces testosterone production and increases the prevalence of hypogonadism

Draft of Russian Clinical Practice Guidelines «Male hypogonadism»

Hypogonadism in males, defined as a decrease in serum testosterone levels in combination with characteristic symptoms and/or signs, can be observed with pathological changes in the testicles and/or pituitary gland, such as Klinefelter’s syndrome, Kallman’s syndrome, as well as in men with metabolic (obesity, diabetes mellitus) or iatrogenic disorders leading to a decrease in androgen production. The draft guidelines cover the extensive range of pathologies that cause hypogonadism development (testosterone deficiency) and focus on its clinical variants, which make up the majority of cases of hypogonadism observed in men. The authors and reviewers are an interdisciplinary group of experts, consisting of endocrinologists, andrologists, urologists - members of the «Russian Association of Endocrinologists» and «Men’s and Reproductive Health» public organizations.Clinical guidelines contain the most reliable evidence available to experts at the time of writing. Nevertheless, recommendations cannot replace clinical experience, and deciding on the start of treatment, choosing a method of therapy, or a drug should always consider the individual characteristics of a specific patient

INTERDISCIPLINARY CLINICAL PRACTICE GUIDELINES "MANAGEMENT OF OBESITY AND ITS COMORBIDITIES"

Clinical guidelines have long been one of the working tools of the modern doctor, helping him quickly navigate the most effective proven methods of treatment and prevention of various diseases, and also to adapt these methods to the specific tasks of their patients and to achieve maximum personalization of treatment. Clinical  practice guidelines are drawn up by professional non-profit associations and are approved by the Scientific Council of the Ministry of Health of the Russian Federation, while often one recommendation is prepared by two or even three associations. The peculiarity of the recommendations offered to your attention is that not only endocrinologists, but also therapists, cardiologists, gynecologists, gastroenterologists, and experts of many other specialties are involved in the prevention and treatment of obesity. The Multidisciplinary Working Group presents this a project in a multidisciplinary journal to bring together the efforts of several professional associations that associated with the need to pay attention not only to obesity itself but also to comorbid conditions. We are looking forward to constructive criticism and a comprehensive discussion of the problem on the pages of our journal

Standards of specialized diabetes care. Edited by Dedov I.I., Shestakova M.V., Mayorov A.Yu. 9th edition

Dear Colleagues! We are glad to present the 9th Edition (revised) 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, 2018, 2019), American Association of Clinical Endocrinologists (AACE, 2019), International Society for Pediatric and Adolescent Diabetes (ISPAD, 2014, 2018) and Russian Association of Endocrinologists (RAE, 2011, 2012, 2015). Current edition of the “Standards” also integrates results of completed randomized clinical trials (ADVANCE, ACCORD, VADT, UKPDS, SAVOR, TECOS, LEADER, EXAMINE, ELIXA, SUSTAIN, DEVOTE, EMPA-REG OUTCOME, CANVAS, DECLARE, CARMELINA, REWIND, 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 in the world increased during the last decade more than two-fold, reaching some 463 million patients by the end of 2019. According to the current estimation by the International Diabetes Federation, 578 million patients will be suffering from diabetes mellitus by by 2030 and 700 million by 2045. Like many other countries, Russian Federation experiences a sharp rise in the prevalence of DM. According to Russian Federal Diabetes Register, there are at least 4 584 575 patients with DM in this country by the end of 2018 (3,1% of population) with 92% (4 238 503) – Type 2 DM, 6% (256 202) – Type 1 DM and 2% (89 870) – other types of DM, including 8 006 women with gestational DM. However, these results underestimates real quantity of patients, because they consider only registered cases. Results of Russian epidemiological study (NATION) con- firmed that only 54% of Type 2 DM are diagnosed. So real number of patients with DM in Russia is 9 million patients (about 6% of population). This is a great long-term problem, because a lot of patients are not diagnosed, so they don’t receive any treatment ant have high risk of vascular complications. Severe consequences of the global pandemics of DM include its vascular complications: nephropathy, retinopathy, coronary, cerebral, coronary and peripheral vascular disease. These conditions are responsible for the majority of cases of diabetes-related disability and death. In сurrent edition of the “Standards”: New goals of glycemic control for the elderly, based on the presence of functional dependence, as well as for pregnant women, children and adolescents, are given. Added a snippet that describes the continuous glucose monitoring. Only low-density lipoprotein cholesterol level is used as a target for lipid metabolism. Proposes more stringent target levels of blood pressure. It also features updated guidelines on stratification of treatment in newly diagnosed Type 2 diabetes: the excess of the initial level of HbA1c over the target level was used as a criterion. In the recommendations for the personalization of the choice of antidiabetic agents, it is taken into account that in certain clinical situations (the presence of atherosclerotic cardiovascular diseases and their risk factors, chronic heart failure, chronic kidney disease, obesity, the risk of hypoglycemia) certain classes of hypoglycemic agents (or individual drugs) have proven advantages. Recommendations for psychosocial support are added. The position of metabolic surgery as a method of treatment of DM with morbid obesity is updated. Recommendations for diagnostic and treatment of hypogonadism syndrome in men with DM are added. For the first time, evidence levels of confidence and credibility levels of recommendations for diagnostic, therapeutic, rehabilitative and preventive interventions based on a systematic review of the literature are given in accordance with the recommendations of the Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation. This text represents a consensus by the absolute majority of national experts, achieved through a number of fruitful discus- sions held at national meetings and forums. These guidelines are intended for endocrinologists, primary care physicians and other medical professionals involved in the treatment of DM. On behalf of the Working Grou

Standards of specialized diabetes care. Edited by Dedov I.I., Shestakova M.V., Mayorov A.Yu. 10th edition

Dear Colleagues!We are glad to present the 10th Edition (revised) of the Standards of Specialized 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), European Association for the Study of Diabetes (EASD 2018, 2019), American Diabetes Association (ADA, 2018, 2019, 2021), American Association of Clinical Endocrinologists (AACE, 2020, 2021), International Society for Pediatric and Adolescent Diabetes (ISPAD, 2018) and Russian Association of Endocrinologists (RAE, 2019). Current edition of the “Standards” also integrates results of completed randomized clinical trials (ADVANCE, ACCORD, VADT, UKPDS, SAVOR, TECOS, LEADER, EXAMINE, ELIXA, SUSTAIN, DEVOTE, EMPA-REG OUTCOME, CANVAS, DECLARE, CARMELINA, REWIND, CREDENCE, CAROLINA, DAPA-CKD, DAPA-HF, EMPEROR-Reduced trial, VERIFY, VERTIS CV, PIONEER, 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 in the world increased during the last decade more than two-fold, reaching some 537 million patients by the end of 2021. According to the current estimation by the International Diabetes Federation, 643 million patients will be suffering from DM by 2030 and 784 million by 2045.Like many other countries, Russian Federation experiences a sharp rise in the prevalence of DM. According to Russian Federal Diabetes Register, there are at least 4 871 863 patients with DM in this country on 01.01.2021 (3,34% of population) with 92,3% (4 498 826)–Type 2 DM, 5,6% (271 468)–Type 1 DM and 2,1% (101 569)–other types of DM, including 9 729 women with gestational DM. However, these results underestimates real quantity of patients, because they consider only registered cases. Results of Russian epidemiological study (NATION) confirmed that only 54% of Type 2 DM are diagnosed. So real number of patients with DM in Russia is 10 million patients (about 7% of population). This is a great long-term problem, because a lot of patients are not diagnosed, so they don’t receive any treatment and have high risk of vascular complications.Severe consequences of the global pandemic 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.In сurrent edition of the “Standards”:New goals of glycemic control for continuous glucose monitoring (time in range, below range and above range, glucose variability) are given.It also features updated guidelines on stratification of treatment in newly diagnosed Type 2 diabetes.In the recommendations for the personalization of the choice of antidiabetic agents, it is taken into account that in certain clinical situations (the presence of atherosclerotic cardiovascular diseases and their risk factors, chronic heart failure, chronic kidney disease, obesity, the risk of hypoglycemia) certain classes of hypoglycemic agents (or individual drugs) have proven advantages.Indications for the use of antidiabetic agents in chronic kidney disease are expanded.Information about insulin pump therapy is added.Recommendations on vaccination are added.An algorithm for replacing some insulin preparations with others is given.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, primary care physicians, pediatricians and other medical professionals involved in the treatment of DM.Compared with previous edition of the Standards of Specialized Diabetes Care edited by Dedov I.I., Shestakova M.V., ­Mayorov A.Yu., 10th edition, Moscow, 2021 (signed for printing on 10.09.2021) a number of changes have been made.On behalf of the Working Grou