Vol 22, No 2 (2019)

Original Studies
Epidemiology of cardiovascular diseases among patients with diabetes mellitus according to the federal diabetes register of the Russian Federation (2013–2016)
Kalashnikov V.Y., Vikulova O.K., Zheleznyakova A.V., Isakov M.А., Bondarenko I.Z., Shestakova M.V., Dedov I.I.

BACKGROUND: Cardiovascular diseases (CVD) are the main cause of death for patients with diabetes mellitus (DM).

AIMS: To evaluate the CVD epidemiology: coronary heart disease (CHD), myocardial infarction (MI) and cerebrovascular diseases in adult patients with type 1 (T1DM) and type 2 (T2DM) diabetes, compare dynamics with data of implementation of the Federal Program «Diabetes mellitus» in 2007–2012 and over the online period 2013–2016.

MATERIALS AND METHODS: The database of the Federal Diabetes register (81 regions at 12.2017). We estimated prevalence and incidence rates/10 thousand (th) adult DM patients over 18 years.

RESULTS: The prevalence of CVD for the period 2007 – 2016 significant decreased in CHD for T1DM from 14,9% to 3,5%, for T2DM from 20,1% to 11,7%; MI for T1DM from 5,7% to 1,3%, for T2DM from 7,6% to 3,5%; cerebrovascular diseases for T1DM from 4,9% to 1,7%, for T2DM from 7,6% to 4,3%, respectively. In 2013→2016 positive trends continued: MI for T1DM 8,2→5,9/10th patients, for T2DM 19,2→14,7/10th patients, respectively; CVD for T1DM 11,3→10,5, for T2DM 29,4→25,4/10th patients, respectively. There was a large heterogeneity of the prevalence of CVD in the regions. MI varied in patients for T1DM from 319/10 th patients to absence, for T2DM from 800 to 7/10 th patients; the development of cerebrovascular diseases for T2DM from 900 to less than 100/10 th patients, which is largely due to differences in their registration. A small number of cases may be due to insufficient filling of the database, the facts of a huge number require further analysis. The average age of development of MI had increased: for T1DM 51,2→53 years, for T2DM 63,5→65 years, cerebrovascular diseases for T1DM 52,3→52.5 years, for T2DM 65,2→66,5, respectively.

CONCLUSIONS: The prevalence of CVD significantly decreased in the Russian Federation compared to 2007–2012, as well as for the period 2013–2016: the prevalence of CHD and cerebrovascular diseases declined, the number of new cases of MI decreased, the average age and duration of DM before the development of CVD significantly increased. These data reflect the results of the program for improvement medical care and prevention measures for patients with diabetes.

Diabetes mellitus. 2019;22(2):105-114
Multidisciplinary lifestyle management approach in patients with type 2 diabetes mellitus in real clinical practice. Results of application “Life is easy” programme in Russia
Motkova S.I., Savelyeva L.V., Rudina L.M., Gurkina M.V., Surkova E.V., Valeeva F.V., Galstyan G.R., Shestakova M.V.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a disease with high medical and social impact due to its wide and ever-increasing prevalence, high hospitalization and mortality rates. Despite the whole range of therapeutic options, lifestyle intervention remains as important as ever since it underlies guidelines of T2DM management.

AIMS: To evaluate the effect of intensive lifestyle management approach on body weight reduction and on long-term maintenance of the achieved results in patients with T2DM.

MATERIALS AND METHODS: We performed multicenter, interventional, prospective, non-randomized 12 month study. One hundred thirty overweight (obese) patients with T2DM included in the study were divided into two groups: group of lifestyle intervention (n=100) and control group (n=30). Patients in the group of lifestyle intervention participated in the intensive lifestyle modification and body weight reduction programme, which consisted of components: change in diet plan, physical exercise programme, cognitive behavioral techniques, educational and medical support. Clinical assessment and completing of patient questionnaires were performed at baseline, after 3 and 12 months. Patients in the control group did not attend programme, their clinical data were recorded during clinical visits every 3 months.

RESULTS: Ninety patients (90%) in the group of lifestyle intervention and twenty nine patients (96.7%) in the control group completed the study and fulfilled protocol. After 12 months, patients in the group of lifestyle intervention lost 5.8% of their baseline weight and patients in the control group showed 1.2% decrease of their baseline weight. Body weight loss ≥5% was observed in 49.2% of patients in the group of lifestyle intervention and in 12.9% of patients in the control group (OR=6.54 [2.01; 21.33]; р=0.002). By the end of observation, delta reduction of glycated hemoglobin (HbA1c) in the intervention group was higher than in the control group (0.79% and 0.11%, respectively), the odds ratio for lowering HbA1c >0.5% from baseline between two groups was 14.10 [3.24; 61.30] (p<0.001) in favor of the group of lifestyle intervention. 58.3% patients in the group of lifestyle intervention with baseline level of HbA1c >7% (n=48) achieved a HbA1c target of ≤7%; in the control group two patients (13.3%) out of fifteen with baseline level of HbA1c >7% achieved the target after 3 months and returned to baseline by the end of observation.

CONCLUSIONS: Our results suggest that the programme of intensive lifestyle modification in patients with T2DM is highly efficient and safe.

Diabetes mellitus. 2019;22(2):115-126
The prevalence of hypogonadism in men with type 2 diabetes mellitus in clinical practice
Melnichenko G.A., Shestakova M.V., Rozhivanov R.V.

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.

Diabetes mellitus. 2019;22(2):127-130
Diagnostic value of ankle peak systolic velocity in diabetic patients with critical limb ischemia
Dzhemilova Z.N., Bondarenko O.N., Galstyan G.R.

AIM: To evaluate the diagnostic value of ankle peak systolic velocity (APSV) in diabetic patients diagnosed with critical limb ischaemia (CLI) and its resolution after percutaneous transluminal angioplasty (PTA).

MATERIALS AND METHODS: Forty-eight diabetic patients with CLI were included in this study. CLI was diagnosed according to the IWGDF 2015 criteria. Patients were examined before and 5–7 days after PTA with transcutaneous oxygen tension of the foot's soft tissues and APSV by duplex ultrasonography.

RESULTS: The median transcutaneous oxygen tensions before and after PTA were 14 [3; 20.5] and 30 [18.5, 39.0] mmHg, respectively (p <0.001). The median APSV in diabetic patients with CLI was 10 [7.4; 15.5] cm/s before PTA and −46 [33.5, 59] cm/s after PTA (p <0.001). The APSV cutoff point for diabetic patients with CLI is ≤25.5 cm/s with a sensitivity of 79.4% [95% CI 62.1–91.3] and a specificity of 96.4% [95% CI 81.7–99.9].

CONCLUSIONS: APSV may be considered as an additional method for CLI assessment. Lower limb artery calcification, soft tissue oedema or infection and foot ulcer and gangrene influence the results of routine ischaemia diagnostic methods such as the ankle–brachial index, toe–brachial index, transcutaneous oximetry but not APSV.

Diabetes mellitus. 2019;22(2):131-140
Electroneuromyography for early diagnosis of diabetic distal polyneuropathy
Mazurenko E.S., Ruyatkina L.A., Pakhomov I.A., Chesheva E.V., Gavrilova L.O.

BACKGROUND: Diabetic distal polyneuropathy (DDPN) is a predictor of diabetic foot syndrome development, ulcer formation and lower limb amputation. An early DDPN diagnosis is therefore relevant.

AIM: To investigate the effectiveness and suitability of electroneuromyography (ENMG) for early DDPN diagnosis.

MATERIALS AND METHODS: This study was performed in the Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya. L. Tsivyan. A total of 80 participants were examined, including 30 DM2 patients, 30 patents without carbohydrate metabolism disorders, and 20 healthy volunteers aged 20–30 years. None of the participants showed clinical signs of distal polyneuropathy (DPN). All participants underwent evaluation of neuropathy symptoms by the Neuropathy Symptom Score scale, neurological assessment using on the scale of Neuropathic Dysfunctional Score and stimulating ENMG.

RESULTS: ENMG revealed the presence of neuropathy in 86.7% of DM2 patients. Moreover, among DM2 patients, 12 (40%) presented sensory DDPN, 13 (43.3%) presented sensorimotor neuropathy and 1 (3.3%) presented motor DDPN. The medial and lateral plantar nerves were the most commonly affected (p = 0.018 and p = 0.002, respectively). Among the 30 control individuals, 9 (30%) showed signs of DPN in combination with radiculopathy. ENMG - indicators of DDPN: latency and amplitude and speed for 3 sensory (n. Plantaris lateralis, n. Plantaris medialis, n. Suralis) and 2 motor nerves (n. Peroneus, n. Tibialis) were significantly worse in individuals with DM2 than in the control group, both for those with and without radiculopathy. Among participants with DM2, those sensorimotor DDPN tended to have a longer diabetes duration (p = 0.503), higher levels of HbA1c (p = 0.077) and higher BMI (p = 0.050) than those with sensory neuropathy, although the differences were not significant.

CONCLUSION: This study confirms the effectiveness and suitability of ENMG for the early diagnosis of DDPN. Moreover, the optimal ENMG indices necessary for this diagnosis were identified.

Diabetes mellitus. 2019;22(2):141-150
Percutaneous coronary intervention for patients with type 2 diabetes mellitus: risks and novel way to manage
Kochergina A.M., Khorlampenko A.A.

The article is a literature review devoted to issues of planned percutaneous coronary intervention for patients with type 2 diabetes mellitus. Pathogenetic base of poor prognosis and new ways to pharmacological risk correction are described.

The article highlights the trends in the incidence of carbohydrate metabolism disorders, their role in the development of complications of myocardial revascularization. The results of studies comparing different tactics of revascularization and their results in patients with different status of carbohydrate metabolism are presented.

The article discusses the methods of risk management within percutaneous coronary revascularization, the role of glycemic metabolism in the risk of an poor prognosis of myocardial revascularization, describes the results of clinical trials of new drugs that can have a positive effect on the prognosis of revascularization in patients with carbohydrate metabolism disorders.

Diabetes mellitus. 2019;22(2):151-158
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
Trubitsyna N.Р., Shestakova M.V.

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.

Diabetes mellitus. 2019;22(2):159-164
Case report
A synonymous variant in GCK gene as a cause of gestational diabetes mellitus
Zubkova N.A., Rubtsov P.M., Burumkulova F.F., Ibragimova L.I., Makretskaya N.A., Vasilyev E.V., Petrov V.M., Tiulpakov A.N.

The diagnosis of MODY as a subtype of gestational diabetes mellitus (GDM) is important for an adequate management during pregnancy and the postnatal period. The present report describes a case of GDM caused by a synonymous с.666C>G р.V222V substitution in the GCK gene. The variant, which was initially ranked as ‘likely benign’, was later proven to be pathogenic by in vitro studies. The с.666C>G substitution led to the use of a new donor splice site and synthesis of the aberrant mRNA with deletion of 16 base pairs. The case illustrates that additional clinical and experimental data may be required for the correct interpretation of sequence variants pathogenicity.

Diabetes mellitus. 2019;22(2):165-169
A clinical case of neonatal diabetes caused by INS gene mutation
Atanesyan R.A., Uglova T.A., Vdovina T.M., Klimov L.Y., Kostanova M.U., Kuryaninova V.A., Stoyan M.V., Alaverdyan L.S., Dolbnya S.V.

Neonatal diabetes mellitus (NDM) is a severe endocrine pathology diagnosed in children during the first months of life. It comprises rare (1:300 000–1:400 000 newborns) metabolic disorders with postnatal pancreatic β-cell dysfunction, manifested by hyperglycaemia and hypoinsulinaemia. It is currently established that molecular genetic diagnosis of neonatal diabetes forms can influence treatment and prognosis. Interestingly, most identified mutations in the insulin gene are not inherited, but are sporadic. There is evidence that, in addition to heterozygous INS mutations, NDM can be caused by homozygous or compound-heterozygous mutations.

The present article presents the clinical case of a girl with NDM associated with an INS gene mutation. INS gene mutations cause permanent diabetes and require children to undergo genetic examination, especially patients with type 1 diabetes in the absence of antibodies.

Currently, there are no data that allow to determine a phenotypic and genotypic ‘portrait’ of NDM forms or to explain the factors determining their occurrence. Further studies of clinical cases of neonatal diabetes are therefore required to determine the characteristics of NDM subtypes with subsequent disease prognosis.

Diabetes mellitus. 2019;22(2):170-176

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