[CROATIAN GUIDELINES FOR THE PHARMACOTHERAPY OF TYPE 2 DIABETES]. / HRVATSKE SMJERNICE ZA FARMAKOLOSKO LIJECENJE SECERNE BOLESTI TIPA 2.

INTRODUCTION: The Croatian Association for Diabetes and Metabolic Disorders of the Croatian Medical Association has issued in 2011 the first national guidelines for the nutrition, education, self-control, and pharmacotherapy of diabetes type 2. According to the increased number of available medicines and new evidence related to the effectiveness and safety of medicines already involved in the therapy there was a need for update of the existing guidelines for the pharmacotherapy of type 2 diabetes in the Republic of Croatia. PARTICIPANTS: as co-authors of the Guidelines there are listed all members of the Croatian Association for Diabetes and Metabolic Diseases, as well as other representatives of professional societies within the Croatian Medical Association, who have contributed with comments and suggestions to the development of the Guidelines. EVIDENCE: These guidelines are evidence-based, according to the GRADE system (eng. Grading of Recommendations, Assessment, Development and Evaluation), which describes the level of evidence and strength of recommendations. CONCLUSIONS: An individual patient approach based on physiological principles in blood glucose control is essential for diabetes' patients management. Glycemic targets and selection of the pharmacological agents should be tailored to the patient, taking into account the age, duration of disease, life expectancy, risk of hypoglyce- mia, comorbidities, developed vascular and other complications as well as other factors. Because of all this, is of national interest to have a practical, rational and applicable guidelines for the pharmacotherapy of type 2 diabetes.

Does treatment of subsyndromal depression improve depression-related and diabetes-related outcomes? A randomised controlled comparison of psychoeducation, physical exercise and enhanced treatment as usual.

BACKGROUND: Elevated depressive symptoms that do not reach criteria for a clinical diagnosis of depression are highly prevalent in persons with diabetes. This study was aimed at determining the efficacy of psychoeducation and physical exercise compared with enhanced treatment as usual on 1-year changes in depressive symptoms, diabetes distress and self-management, and quality of life and metabolic control in type 2 diabetes patients with subsyndromal depression. METHODS: Adult type 2 diabetes patients who screened positively for depression and expressed a need for professional help with mood-related issues were eligible. Exclusion criteria were clinical depression, current psychiatric treatment and advanced diabetes complications. Out of 365 eligible patients 209 consented to either 6 weekly sessions of psychoeducation (A) and physical exercise (B), or to enhanced treatment as usual (C). Computer-generated sequences for block randomisation stratified by gender were used. Depressive symptoms (primary outcome) and diabetes distress, diabetes self-care, metabolic control and health-related quality of life (secondary outcomes) were analysed at 6-month and 12-month follow-up using repeated-measures ANOVAs. RESULTS: Out of the 74 patients randomised into group A, 66 into B and 69 into group C, 203 completed the interventions, and 179 patients with all 3 assessments were analysed. Depressive symptoms in participants from the psychoeducational, physical exercise and the enhanced treatment as usual groups improved equally from baseline to 12-month follow-up (time versus time x group effect; F = 12.51, p < 0.001, η(2) = 0.07 and F = 0.609, p = 0.656, η(2) = 0.007 respectively), as did diabetes distress and quality of life (all p < 0.001), diabetes self-care (p < 0.001 to < 0.05), triglycerides, and total cholesterol and LDL-cholesterol (p < 0.001). CONCLUSIONS: The employed interventions had comparable positive effects on 12-month psychological and diabetes-related outcomes suggesting that even minimal intervention addressing patients' diabetes-related problems and concerns had favourable clinical implications and might be sufficient to treat subsyndromal depression. Further investigation is warranted to clarify possible mechanisms of improvement. TRIAL REGISTRATION: Current Controlled Trials ISRCTN05673017. The message on assigning the above mentioned ISRCTN was received on 11 August 2010.

Improvement in Depressive Symptoms Is Associated with Reduced Oxidative Damage and Inflammatory Response in Type 2 Diabetic Patients with Subsyndromal Depression: The Results of a Randomized Controlled Trial Comparing Psychoeducation, Physical Exercise, and Enhanced Treatment as Usual.

Aims. To examine one-year changes in oxidative damage and inflammation level in type 2 diabetic patients undergoing behavioral treatment for subsyndromal depression. Materials and Methods. A randomized controlled comparison of psychoeducation (A), physical exercise (B), and enhanced treatment as usual (C) was performed in 209 eligible subjects in a tertiary diabetes care setting. Depressive symptoms (primary outcome) and selected biomarkers of oxidative damage and inflammation (secondary outcomes) were assessed at baseline and six- and twelve-month follow-up. Results. Out of the 74, 67, and 68 patients randomised into groups A, B, and C, respectively, 201 completed the interventions, and 179 were analysed. Participants in all three groups equally improved in depressive symptoms from baseline to one-year follow-up (repeated measures ANOVA; F = 12.51, p < 0.0001, η (2) = 0.07). Urinary 8-oxo-deoxyguanosine (u-8-oxodG) decreased (F = 10.66, p < 0.0001, η (2) = 0.06), as did sialic acid and leukocytes (F = 84.57, η (2) = 0.32 and F = 12.61, η (2) = 0.07, resp.; p < 0.0001), while uric acid increased (F = 12.53, p < 0.0001, η (2) = 0.07) in all subjects during one year. Improvement of depressive symptoms at 6 months significantly predicted one-year reduction in u-8-oxodG (ß = 0.15, p = 0.044). Conclusion. Simple behavioral interventions are capable not only of alleviating depressive symptoms, but also of reducing the intensity of damaging oxidative/inflammatory processes in type 2 diabetic patients with subsyndromal depression. This trial is registered with ISRCTN05673017.

Effects of an empowerment-based psychosocial intervention on quality of life and metabolic control in type 2 diabetic patients.

This study was aimed at determining impact of an empowerment-based psychosocial intervention on the patients' quality of life and glycemic control as compared to patients in standard care. Consecutively recruited type 2 diabetic patients, scheduled for their regular medical check-ups, were individually acquainted with empowerment-based principles and invited to participate in an empowering psychosocial course. The response rate was 35% giving a number of 73 patients who were treated in eight separate groups. The treated patients reported their quality of life to be improved after the course regarding its psychological and social aspects. Their glycemic control also improved and remained so after 3- and 6-month follow-up periods, still being in a category of poor control. Empowerment-based psychosocial intervention in type 2 diabetic patients was shown to favourably affect their quality of life and to improve their metabolic control, the latter in a modest degree. Better educated patients believing in internal health control and efficacy of diabetes treatment seemed to benefit the most. Further research is needed in order to highlight individual preferences for different educational approaches, as well as social and cultural factors affecting them.

Redefinition of gestational diabetes mellitus: implications for laboratory practice in Croatia.

An increasing prevalence of gestational diabetes has become a very challenging task in prenatal care worldwide. International Association of Diabetes and Pregnancy Study Groups (IADPSG) has recently issued recommendations on the diagnosis and classification of hyperglycaemia in pregnancy. These recommendations, the first to provide harmonised, evidence-based criteria for the diagnosis and classification of diabetes in pregnancy, are currently being discussed and accepted worldwide by the relevant authorities. As the acceptance of the proposed criteria has major implications for both clinical and laboratory settings, a concerted action towards necessary changes in practice has to be carefully planned and adjusted to national health-care specificities. IADPSG criteria have been strongly advocated by the Croatian Perinatology Society, resulting in a new strategy for the detection and diagnosis of hyperglycaemic disorders in pregnancy. To address the respective laboratory requirements, in April 2012, the Croatian Chamber of Medical Biochemists appointed a Working Group to provide a standardised procedure for the diagnosis of gestational diabetes, applicable to all laboratories involved in prenatal care, in both primary and specialised health-care facilities. In this paper we discuss key laboratory-related issues regarding succesful implementation of the IADPSG criteria in Croatia.

Gender differences in the control of cardiovascular risk factors in patients with type 2 diabetes -a cross-sectional study.

OBJECTIVE: Trends in diabetes and cardiovascular mortality rates are considerably different between women and men; this can be partially explained by differences in diabetes control. The aim of this cross-sectional study was to assess whether sex differences exist in effective control of cardiovascular risk factors among persons with type 2 diabetes treated at the Vuk Vrhovac University Clinic in 2008. MATERIALS AND METHODS: We performed a cross-sectional analysis including 8,775 patients who attended the clinic in 2008. Levels of HbA1c, systolic and diastolic blood pressure (SBP, DBP), LDL-cholesterol (LDL) and triglycerides (TG) were analyzed. Multiple adjusted odds-ratios were calculated for categories of cardiovascular risk factors considered not being in control (HbA1c ≥ 7%, SBP ≥ 130 mmHg, DBP ≥ 80 mmHg, LDL ≥ 2.5 mmol/L, TG ≥ 1.7 mmol/L). RESULTS: Women had higher levels of HbA1c (7.05 vs. 6.86%; p<0.001), despite the fact that a larger proportion of women were receiving insulin therapy than men (51.3% vs. 44%). Women also had higher mean values of SBP (144.7 vs. 141.9 mmHg; p<0.001) and LDL (2.92 vs. 2.84 mmol/L). There were no differences in DBP (86.1 vs. 86.0 mmHg; p=0.748) and only triglyceride levels were higher in men (2.04 vs. 1.94 mmol/L; p=0.003). In multi-adjusted logistic regression model female sex was associated with a higher odds ratio of having uncontrolled values of HbA1c (OR=1.21; 95%CI 1.11-1.32), SBP (OR=1.21; 95%CI 1.07-1.37) and LDL (OR=1.13; 95%CI 1.04-1.23). CONCLUSION: Women with diabetes have poorer control of main potentially modifiable cardiovascular risk factors than men. This could contribute to disparities in trends in cardiovascular mortality and it demands clinicians' and public health awareness.

Estimating glomerular filtration rate (GFR) in diabetes: the performance of MDRD and CKD-EPI equations in patients with various degrees of albuminuria.

OBJECTIVES: The aim of this study was to compare the performance of Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Modification of Diet in Renal Disease Study (MDRD) equations in estimating GFR in a large cohort of diabetic patients with various degrees of albuminuria. DESIGN AND METHODS: In a group of 842 diabetic patients GFR was estimated from standardized creatinine, with MDRD-Study and CKD-EPI equations, and their performance evaluated regarding clinical stages of albuminuria and chronic kidney disease (CKD). RESULTS: Patients with normoalbuminuria had higher eGFR when calculated by CKD-EPI, than MDRD-Study equation [median (IQR): 103 (91-115) vs 97 (85-113)mL/min/1.73 m(2), P=0.006, n=364], which significantly influenced the prevalence of stage 1 CKD [eGFR>90 mL/min/1.73 m(2): 76.7% (CKD-EPI) vs. 65.1% (MDRD-Study), P=0.005]. There were no differences between the eGFR values derived by two equations in patients with micro- and macroalbuminuria, and more advanced staging of CKD. CONCLUSION: CKD-EPI equation might be a superior surrogate marker of GFR in patients with normoalbuminuria and hyperfiltration and could be used as a screening tool for early renal impairment in diabetes. It's validity as a marker of progression of diabetic nephropathy merits further investigation.

Impact of a guide dog on glycemia regulation in blind/visually impaired persons due to diabetes mellitus.

The aim was to assess glycemia regulation in a blind diabetic patient after getting a guide dog. Glycosylated hemoglobin (HbA1c) results of a blind patient before and after getting the guide dog were retrospectively collected. The paired t-test results yielded a two-tailed P value of 0.0925, a difference considered not statistically significant; the 95% confidence interval of this difference varied from -0.2494 to 1.889. An improvement of glycemia regulation was observed with the guide dog compared to previous glycemia regulation, however, the difference was not statistically significant. The moderate improvement could probably be attributed to the mobility of the blind person having a guide dog. Standard quality of life tests should be included in the evaluation of diabetic blind persons, especially the impact of a guide dog on glycemic control or other chronic complications of diabetes.