Vol 22, No 5 (2019)

Original Studies
Сhronic kidney disease complications in patients with type 1 diabetes mellitus after simultaneous pancreas-kidney transplantation – potential role of oxidative stress and glycation end products
Larina I.I., Severina A.S., Shamkhalova M.S., Egorova D.N., Nikankina L.V., Sazonova N.I., Dmitriev I.V., Pinchuk A.V., Kaabak M.M., Shestakova M.V.

BACKGROUND: Normoglycaemia in patients with diabetes mellitus type 1 (T1DM) after simultaneous pancreas-kidney transplantation (SPKT) is very interesting in regards to chronic kidney disease (CKD) complications dynamics depending of posttransplantation period and possible targets of potential treatment from the point of view “metabolic memory”

AIM: To evaluate the relationship between oxidative stress indicators and advanced glycation end products and complications of end-stage renal disease (ESRD) in patients with T1DM аnd a long-term history of diabetes decompensation, who reached stable euglycemia after SPKT.

MATERIALS AND METHODS: The study included 20 patients with compensation of carbohydrate metabolism after SPKT performed from November 2011 to September 2018. Assessment included examination of complications of ESRD (arterial hypertension, dyslipidemia, anemia, mineral and bone disorder) and analysis of "metabolic memory" markers: 3-nitrothyrosine (3-NT), superoxide dismutase (SOD), advanced glycation end products (AGE) and AGE receptor (RAGE). We performed follow-up examination of patients included in the early postoperative period (1st day/week) in 6-12 months after SPKT.

RESULTS: All patients with DM1 duration for 22 [19; 28] years, diabetic nephropathy (DN) 8 [6; 14] years and duration of renal replacement therapy (dialysis) for 3 [1.5; 4] years reached euglycemia (HbA1c 5,5 [5,1; 5,8] %; С-peptide 3,2 [2,45; 3,63] ng/ml) after 6 month of surgical treatment. Despite of stable graft function (estimated glomerular filtration rate (eGFR) CKD-EPI 84 [69; 95] ml/min/1.73m2) 35% of patients still needed antihypertensive therapy, 40% needed treatment with recombinant human erythropoietin (RHuEPO) and 15% – ferrotherapy. With vitamin D deficiency, observed in 80% of cases (13.3 [9.3; 18.5] ng/ml), 55% of patients had secondary hyperparathyroidism, 45% – osteoporosis. The results of the correlation analysis revealed the association of the state of ESRD target organs with the studied "metabolic memory" markers: oxidative stress and AGE-RAGE system.

CONCLUSIONS: SPKT as the way to achieve compensation of carbohydrate metabolism and uremia does not provide regress of diabetes and complications of ESRD. Analysis of "metabolic memory" markers indicate their direct contribution to the persistence of metabolic consequences of diabetic nephropathy (DN). Found trends need more long-lasting observation and enlargement of study groups.

Diabetes mellitus. 2019;22(5):405-416
The effect of vitamin D therapy on inflammatory markers in patients with type 2 diabetes mellitus and diabetic peripheral polyneuropathy
Stepanova A.P., Karonova T.L.

BACKGROUND: The pathogenesis of diabetic peripheral neuropathy (DPN) in patients with type 2 diabetes mellitus (T2DM) is multifactorial, and includes increased inflammation. In recent years, the effect of vitamin D therapy on improving the profile of inflammatory parameters has been actively studied.

AIMS: The aim of this study was to assess inflammation markers before and after various doses of cholecalciferol therapy in T2DM with DPN.

MATERIALS AND METHODS: Single-center open randomized study included T2DM patients with PDN. Sixty-seven patients were randomized into 2 groups. For 24 weeks Group I have been taking a dosage of cholecalciferol 5,000 IU/week, and Group II a dosage of 40,000 IU/week. At the baseline and in the end of the research there have been studied body mass index (BMI), glycated hemoglobin (HbA1c), 25-hydroxyvitamin D (25(OH)D), PTH, interleukin-1β, -6, -10 (IL), C-reactive protein (CRP), tumor necrosis factor -α (TNFα).

RESULTS: Sixty-two patients completed the study. Group I (n=31, F16), Group II (n=31, F15) were initially compared by age, sex, BMI and НbA1clevel. Vitamin D deficiency/insufficiency was detected in 78% of patients with T2DM. After 24 weeks of therapy with cholecalciferol in Group II there was a significant decrease in BMI, HbA1c, IL-6 levels and an increase in IL-10 levels while no changes were found in Group I. There has been established a correlation between the final level of 25(OH)D and IL-6 (r=-0.378, p=0.036), IL-10 (r=0.483, p=0.006), BMI (r=-0.388, p=0.031) and НbA1c(r=-0.388, p=0.031).

CONCLUSION: The intake of cholecalciferol at a dosage of 40,000 IU/week for 24 weeks is associated with a decrease in BMI, improvement of glycemic control and pro-inflammatory markers profile in patients with T2DM with DPN. Study results showed that the normalization of serum 25(OH)D level can be one of the modifying factors for the development and progression of DPN in patients with T2DM.

Diabetes mellitus. 2019;22(5):417-427
Informativeness of bone intraoperative culture for diagnose osteomyelitis in diabetic foot patients.
Tsvetkov V.O., Kolovanova O.V., Frolova O.E., Gusarova T.A., Ezhova L.G.

BACKGROUND: Diagnosis of osteomyelitis in diabetic foot patients is frequently not obvious due to similar clinical and X-ray signs of bone infection and Sharcot osteopathy, but it is very important because of opposite approach to treatment of these conditions. Today we do not have reliable parameters to determine the devastation of bone infection and, therefore, the rational volume of bone resection and debridement.

AIMS: To determine the diagnostic value of bone culture for osteomyelitis in diabetic foot patients.

MATERIALS AND METHODS: 177 patients underwent surgery due to different forms of diabetic foot. In 131 of them clinical signs of osteomyelitis were revealed and this diagnosis was confirmed by histology. 46 patients with diabetes who underwent high-level amputation without bone infection formed the control group. Intraoperative bone cultures and histological samples were taken in all cases.

RESULTS: We found similar microbial landscape in various forms of diabetic foot and in control group. The frequency of positive intraoperative cultures in patients without osteomyelitis was detected as 63%. The sensitivity of bone culture was counted as 86,3%, the specificity – as 37%, the accuracy – 73.5%.

CONCLUSIONS: Our findings suggest that bone culture is not reliable sign of bone infection in diabetic foot patients due to its low specificity. In our judgment, the only way to determine rational level of bone resection is visual intraoperative assessment and clinical signs such as development of granulation tissue and wound healing.

Diabetes mellitus. 2019;22(5):428-435
Condition of bone tissue in postmenopausal women with type 2 diabetes mellitus of Buryat population
Bardymova T.P., Mistiakov M.V., Yagelskaya G.P.

BACKGROUND: In most countries, there is a rapid increase in the population of patients with type 2 Diabetes Mellitus (DM). Bone changes in postmenopausal women with type 2 DM are associated with increased bone mineral density (BMD). The study of metabolic processes in bone tissue in comorbid pathology in different ethnic groups is continuing.

AIMS: To study the concentration of markers of bone remodeling and indicators of BMD in postmenopausal women with type 2 DM of the Buryat population.

MATERIALS AND METHODS: Thirty-nine postmenopausal women with type 2 DM (22 – Russian population and 17 – Buryat population) were examined. The comparison group consisted of 42 postmenopausal women (21 – Russian population and 21 - Buryat population). The study of BMD in the lumbar spine (L1-L4), the femoral neck (Neck), and the proximal femur (Total hip) was performed using dual-energy X-ray absorptiometry. Parameters of osteocalcin (OC), type 1 N-terminal procollagen propeptide (P1NP), C-terminal telopeptides of type I collagen (β-Cross laps), 25(OH) vitamin D and ionized calcium were evaluated.

RESULTS: The presented study revealed a simultaneous increase in osteosynthesis: ОС (p=0.048) and P1NP (p=0.016) and in the bone resorption marker β-Cross laps (p=0.020) accompanied by the absence of changes in BMD in women with type 2 DM in the postmenopausal period of the Buryat population relative to women with type 2 DM in the postmenopausal state of the Russian population. A decrease in osteosynthesis parameters (ОC, p=0.021; P1NP, p=0.029) with an increase in BMD L1-L4 (p=0.024) and BMD Total hip (p=0.039) in postmenopausal women with type 2 DM of the Buryat population was found relative to the women of the Buryat population in comparison group.

CONCLUSIONS: The state of bone tissue in postmenopausal women with type 2 DM of the Buryat population is characterized by the activation of bone remodeling processes.

Diabetes mellitus. 2019;22(5):436-443
Association between hypogonadism and reproductive tissue steroid-producing cells antibody in men with positive MAR test IgG and diabetes mellitus type 1
Rozhivanov R.V., Vitiazeva I.I.

BACKGROUND: Autoimmune hypogonadism is frequently taped in men with positive direct mixed agglutination reaction antisperm antibodies IgG test (MAR test IgG).

AIMS: Тo assess pathogenetic factor of autoimmune hypogonadism in men with positive MAR test IgG and diabetes mellitus type 1 (DM1).

MATERIALS AND METHODS: A retrospective study included 97 patients with positive direct MAR test IgG: 30 men with DM1 and 67 – without DM. Assessment included testosterone level and titer of summary reproductive tissue steroid-producing cells antibody (LCA). Statistically significant differences were p<0,05.

RESULTS: 43% of men with DM1 have abnormal LCA titer and it was significantly higher than in patients without DM – 21%. In both groups testosterone level was significantly lower in men with abnormal LCA titer than in patients with normal antibodies titer. Frequency of hypogonadism in men with abnormal LCA titer was significantly higher than in patients with normal antibodies titer also in both groups. There were no significantly differences of MAR test IgG in patients with normal and abnormal LCA titer.

CONCLUSIONS: Autoimmune hypogonadism is a common complication in men with DM1 and positive MAR test IgG and its strongly associated with high titer of summary reproductive tissue steroid-producing cells antibody.

Diabetes mellitus. 2019;22(5):444-447
Economic benefit of using testosterone gel (used externally) in men with diabetes mellitus and testosterone deficiency
Astapovskiy A.A., Bagdasaryan A.A., Aref’ev K.I., Serebrova S.Y., Shikh E.V., Drozdov V.N.

BACKGROUND: High prevalence of type 2 diabetes mellitus (T2DM) and its input to the increase of mortality indicate that social and economic value of this disease and financial burden are great. Testosterone replacement therapy (TRT) enhances the effectiveness of T2DM treatment. A research was conducted to assess if Androgel® therapy in diabetic men is cost-effective.

OBJECTIVES: Defining of economic benefit of adding “Androgel” to the T2DM treatment in men with testosterone deficiency.

MATERIALS AND METHODS: Economic modeling and results of other clinical studies were used in the analysis. A guildeline of The Scottish Intercollegiate Guidelines Network (SIGN) was used for clinical study selection, development of economic modelling and study design, assessment of study quality. The study analyzed clinical effects (fasting morning glycemia, glycosylated hemoglobin, HOMA index) and mortality reduce.

RESULTS: It was shown that TRT can help to reduce costs of glycemic control, to increase efficiency in terms of cost-effectiveness analysis. Target HbA1c value can be reached by additional cost of 569.39 roubles for every patient. There is a possible additional income from 454.100 to 8.896.186 rubles though reduced mortality.

CONCLUSION: Thus, testosterone replacement therapy was shown as cost effective due to reduced costs. The analysis demonstrated HbA1c target achievement and, as a result, reduction of the T2DM outcomes and reduced mortality. There is a possible additional income from 454.100 to 8.896.186 rubles per year.

Diabetes mellitus. 2019;22(5):448-454
Diabetic retinopathy: a tool for cardiovascular risk stratification
Avogaro A., Fadini G.

Randomized, cross-sectional, and prospective studies have demonstrated that microvascular complications in patients with diabetes are not only the cause of blindness, renal failure and non-traumatic amputations, but also powerful predictors of cardiovascular complications. The pathophysiology of diabetic microvascular complications is determined by several factors including epigenetic modifications, and reduced release of circulating progenitor cells by the bone marrow. Identifying microvascular complications, in particular retinopathy, increases the ability to stratify patients in terms of cardiovascular risk. There may no longer be a rational to consider microangiopathy and macroangiopathy as entirely separate entities, but they should most likely be viewed as a continuum of the widespread vascular damage determined by diabetes mellitus.

Diabetes mellitus. 2019;22(5):455-460
The role of incretin-based therapies in the management of type 2 diabetes mellitus: perspectives on the past, present and future
Meier J.

The ever-increasing burden of type 2 diabetes mellitus (T2DM) worldwide, has led to the emergence of several antidiabetes drugs with different modes of action. Incretin hormones and their effect on glucose metabolism and pathogenesis of T2DM has been a landmark discovery in the management of this increasingly prevalent metabolic disorder. Glucagon like peptide-1 (GLP-1) receptor agonists and dipeptidyl peptidase-4 (DPP-4) inhibitors are the two major classes of incretin-based therapies that regulate glucose mechanism through multiple pathways, demonstrate weight loss (GLP-1 receptor agonists) or a weight-neutral effect (DPP-4 inhibitors), and are associated with a low risk of hypoglycaemia and other adverse events. In addition, evidence reflects their possible therapeutic potential in the treatment of other clinical conditions such as obesity, cardiovascular disease and liver disorders. This review explores the availability and the impact of GLP-1 receptor agonists and DPP-4 inhibitors as potential therapeutic strategies for T2DM along with their future in the landscape of diabetes management and other clinical conditions.

Diabetes mellitus. 2019;22(5):461-466
Heart failure outcomes in patients with type 2 diabetes mellitus: findings from the cardiovascular outcome trials of antidiabetes agents
Anker S.

Type 2 diabetes mellitus (T2DM) is a recognised risk factor for several cardiovascular (CV) conditions including heart failure (HF). Findings that reflect CV risk associated with T2DM medications have led to regulatory requirement of conducting CV outcome trials (CVOTs) for new antidiabetes drugs. Over the years, several CVOTs using different glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase-4 inhibitors and sodium-glucose co-transporter-2 inhibitors have reported neutral or improved CV risks or hospitalisation for HF. However, these studies included only a small proportion of the patients with baseline HF thus limiting the available evidence. Ongoing trials such as EMPEROR programme and DAPA-HF in large patient populations with chronic HF could potentially broaden the use of these drugs beyond their conventional therapeutic indication.

Diabetes mellitus. 2019;22(5):467-472
Approaches to vaccine prophilaxis of respiratory infections in patients with diabetes mellitus in the modern epidemiological situation
Tarasova A.A., Kostinov M.P., Paramonova J.A.

This review highlights the problems of vaccine prophylaxis of pneumococcal infection and influenza in patients with type 1 and type 2 diabetes mellitus (CD1 and CD2). The features of pneumococcal infection and influenza in conditions of unsatisfactory compensation of the disease are described. The necessity of protection against pneumococcal infection and influenza in the modern epidemiological situation is justified. Results of efficacy and safety of vaccination, including those in children with type 1 diabetes mellitus, are established. The existing foreign and domestic regulatory documents on vaccine prevention of actual infections are shown.Despite the available documents on vaccination of patients with diabetes, there are problems with inadequate immunization coverage of patients with CD1 and CD2 due to the lack of precise clinical recommendations for the management of these categories both inpatient and outpatient as these recommendations do not cover the questions of vaccine prophylaxis. In Russian studies only the treatment regimens are evaluated without taking into account the fact that vaccines are related to medicines and that the prevention of respiratory infections is a curative measure and can inhibit the development of complications of diabetes.It is necessary to coordinate the work of general practitioners, pediatricians, therapists and the efforts of endocrinologists to increase the coverage of immunization of patients with various forms of diabetes mellitus.

Diabetes mellitus. 2019;22(5):473-480
Special aspects of concentrated insulins: basic characteristics and research findings
Demidova T.Y., Balutina O.V.

The appearance of concentrated insulins in clinical practice determines the need to analyze product priorities in appropriate groups of patients with diabetes. The aim of this article is to summarize the literature on concentrated insulins (i.e. insulin lispro 200 units/mL, insulin degludec 200 units/mL, insulin glargine 300 units/mL) from randomized controlled trials, derive guidance on appropriate and safe use of these agents and demonstrate experience in real clinical practice. Severe hypoglycemia in all studies was generally low (though higher with prandial plus concentrated basal analogue therapy), and statistical improvements in other hypoglycemia categories were observed for concentrated basal insulins versus insulin glargine 100 units/mL. In all analyzed data hypoglycemic effect of insulin glargine 300 units/mL was equitable to insulin glargine 100 units/mL. Other important findings demonstrate more constant and prolonged insulin action with low within-subject/ between-day variability for insulin glargine 300 units/mL versus insulin glargine 100 units/mL, therefore, more physiological treatment might prevent from diabetic microvascular complications. The results of randomized trials are comparable with our clinical practice experience and indicate efficacious and safe glucose-lowering properties without risk of severe hypoglycemia.

Diabetes mellitus. 2019;22(5):481-490
Case report
Combination of active stage of diabetic Charcot neuroosteoarthropathy and diabetic lower limb macroangiopathy
Demina A.G., Bregovskiy V.B., Karpova I.A.

Combination of active stage of diabetic Charcot neuroosteoarthropathy and diabetic lower limb macroangiopathy is the rare condition. In the present paper we describe two cases of development of acute Charcot foot in the non-critically ischemic foot. The first case is the patient with previously diagnosed intermitted claudication and the second case is patient who developed the Charcot foot 5 months later after successful endovascular treatment of arterial occlusions of his left lower limb. In both cases the absence of redness in the early stage, the mild-to-moderate pain and mild temperature gradient between affected and non-affected feet were noticed. The clinical course of the Charcot disease in the first patient was favourable. He used walker for 9 months and his foot shape was preserved and deformity was considered as mild. The second patient had more active and profound destructions due to delay of the treatment. He was casted, however his deformity progressed and the treatment continues up to date. In both patients the MRI revealed more affected bones compared with X-ray. These cases emphasize the importance of keeping in mind the Charcot disease even in patients with diabetic peripheral vascular disease.

Diabetes mellitus. 2019;22(5):491-498
CORRIGENDUM: Predicting diabetic self-care management based on the theory of planned behavior among elderly with type 2 diabetes in Thailand (Diabetes Mellitus.2019;22(3). DOI: 10.14341/dm10290)
Wongrith P.

A corrigendum on « Predicting diabetic self-care management based on the theory of planned behavior among elderly with type 2 diabetes in Thailand» by Paleeratana Wongrith (2019). Diabetes Mellitus. 22(4). doi: 10.14341/DM10290
There are some errors on the page 368: source [11] should be replaced by [9], [12] – [11], [13] – [12], [14] – [13], [15] – [14].
The author apologizes 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.

Diabetes mellitus. 2019;22(5):499-499

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