AND PSYCHOLOGICAL FACTORS ON METABOLIC CONTROL OF PATIENTS WITH TYPE 2 DIABETES MELLITUS

Background/Aim. Achieving good metabolic control, which play a key role in reducing or preventing macrovascular and microvascular complication of diabetes, requires continuous patient involvement in self-management of diabetes. This continued engagement, which makes type 2 diabetes (T2DM) one of most demanding diseases, physically and emotionally, can become, at certain periods of life, too severe and lead to emotional distress (symptoms of depression and diabetes-related distress) and deterioration of metabolic control. The aim of this study was to examine association and influence of behavioral and psychological factors on the metabolic control of patients with T2DM. Methods . The research was conducted as a descriptive-analytic cross-sectional study. The method of random sampling included 324 subjects with T2DM in research. The values of biochemical parameters of metabolic control were measured by standard laboratory methods. Blood pressure was measured in two times and the arithmetic mean was calculated. Anthropometric measurement were performed and Body Mass Index (BMI) was calculated. Attitudes toward medication adherence, adherence to dietary recommendations, level of physical activity, presence of depressive symptoms and level of diabetes-related distress were examined using standardized questionnaires. Results. The target values of metabolic control parameters were reached by 21.6% of respondents. Multivariate analysis as predictors of poor metabolic control identified: obesity, non-adherence toward dietary recommendations, insulin therapy, low level of physical activity and clinically significant diabetes-related distress. Conclusions. Routine application of the questionnaire used in this study in initial stages or critical moments of disease can assess patient’s attitudes and knowledge about behavioral determinants of diabetes self-management and timely detect psychological conditions that affect them. It would be realistic to expect that such a comprehensive holistic approach would contribute to lower incidence of complication and better metabolic control of T2DM.

Despite the importance of problem and attitudes about the need for holistic and multidisciplinary approach to patients with T2DM, studies that comprehensively consider metabolic control are limited. Therefore, the purpose of this study was to examine the association and influence of behavioral and psychological factors on metabolic control of patients with T2DM.

Selection method, size and construction of sample
The research was conducted as a descriptive-analytical cross-sectional study.

Level of physical activity
It was assessed by the Physical Activity subscale of Personal Diabetes Questionnaire

Symptoms of depression
The symptoms of depression were assessed using Patient Health Questionnaire-9 (PHQ-), which validated as a screening instrument for use in Primary Health Care in Serbia. The questionnaire consist 9 questions about symptoms and signs of depression. According to achieved scores, the subjects are classified into 4 groups: absence of symptoms of depression (score =0-4); mild symptoms of depression (score: 5-9); moderate symptoms of depression (score [10][11][12][13][14]; moderate to severe symptoms .

Diabetes-related distress
The diabetes-related distress was assessed by Diabetes Distress Scale. The questionnaire differentiates 3 groups of subjects: with little or no distress (score > 2); with moderate distress (score = 2-2.9); with high, clinically significant distress . The questionnaire showed good internal consistency (Cronbach α=0.93).

Statistical Analyzes
Statistical data processing was performed using the statistical program IBM SPSS 21.0.
Data processing included methods of descriptive and inferential statistics. Numerical

Demographic and clinical characteristics
The Clinical characteristics of respondents stratified by gender are shown in Table 2.

Research variables
Medication adherence

Physical activity
The results obtained using the subscale of Physical activity PDQ indicate that more

Symptoms of depression
In our study population, every second respondent had mild to moderate depression (n=154; 50,6%), every tenth (n=33; 10,2) had moderate to severe depression, while two-fifths had no symptoms of depression. The results of univariate analysis showed that female sex (p<0.001), level of education elementary of lower (p=0.003), insulin therapy with load (p=0.001) and the presence of complications (p=0.002) were statistically significantly related to symptoms of depression.

Diabetes related distress
By dichotomizing the value of total scores and scored associated subscales into categories of clinically significant distress (score ≥ 3) and no distress or moderate distress without clinical significance (score < 3) we obtained that clinically significant distress was present in 114 (35.2%) of respondents. The results of univariate analysis showed that female sex (p=0.006), higher levels of education (p=0.029), insulin therapy with load (p<0.001), three and more therapeutic doses daily (p=0.031) and the presence of complication (p=0.005) were statistically significantly related to clinically significant distress.

Relationship and predictive influence of examined variables on the metabolic control of subjects with T2DM
Slightly less than quarter of respondents in research sample met all three goals of good metabolic control (n=70; 21.6%). Data on the values of metabolic control parameters of the subjects in our study sample are shown in Table 3.
In order to determine correlation and prediction of good metabolic control defined by achieving the target values of all three metabolic parameters, binary logistic model was analyzed. The first step was the application of univariate analysis with a dichotomized dependent variable metabolic control (good-met all three goals and bed-not met all three goals). Some socio-demographic and clinical characteristics of respondents, behavioral determinants of diabetes self-management and psychological characteristics of the respondents (symptoms of depression and diabetes-related distress) were applied as dependent variables in the model. Detailed data are shown i Table 4.
As a results of univariate analysis showed that the metabolic control of subjects can be associated with a number of variables between which there may be an independent relationship, using multivariate analysis evaluated variables which can be independent predictors, unlike others that affect metabolic control only as cofactors. The results are shown in Table 5 Discussion In the conducted research, all three goals of metabolic control are met by 21.6% of respondents, which is significantly better than the results of studies conducted in Japan and Poland . Females in this study have poorer metabolic control than males, which us consistent with results others published The higher prevalence of psychological distress (symptoms of depression, and diabetes-related distress), negative attitudes toward medication adherence, as well as lower level of physical activity caused by traditional social roles of this gender group may be explanation for this finding.
An interesting finding is that older people ( > 65 years) have better metabolic control than people < 65 years of age. The same age distribution of metabolic control is indicated by This interesting finding can be explained by understanding of people with T2DM that the introduction of insulin into therapy means that the disease is in a phase that is difficult to control, which leads to clinically significant distress with negative impact on metabolic control. Furthermore, fear of hypoglycemia is present in 29.4% of our subjects on insulin therapy, which leads them to take larger amounts of food and reduce physical activity in order to avoid hypoglycemia. One explanation for this finding that should be considered in future research, is that diabetes-related distress is a major barrier to initiating insulin therapy, and that clinical inertia in the introduction of insulin into T2DM therapy is one of the reasons for poorer metabolic control in this group of . In this study, clinically significant diabetes-related distress stands out as a significant predictor of poor metabolic control (OR=2.26; CI=1. 29-5.35). Diabetes-related distress can affect metabolic control directly through pathophysiological processes (hypothalamicpituitary axis activation, increased sympathetic activity and insulin resistance), and indirectly through diabetes self-management, which may explain this .

Conclusion
The study was conducted as a cross-sectional study on a representative sample.
The advantage of studies of this type is that they enable good control of measurements and assessment of the prevalence of research determinants. However, the key disadvantage of these studies is impossibility of gaining insight of time sequence of the examined phenomena, i.e. it is not possible to determine the direction of causality for which longitudinal studies are necessary.
As self-completing questionnaires used as research instruments, recall bias and giving socially desirable answers could not be completely avoided. The construction of individual questionnaires enabled bias of the central tendency, i.e. giving answers that were in middle of the scale of offered answers.
Despite existence of these limitations, the representativeness of the sample, random sampling methods, and the use of internationally recognized standardized research instruments give significant strength to conducted study.
This study provides insight and understanding of a wide range of issues in the context of self-management of diabetes, which is key to achieving a much more effective approach to patients with T2DM. The available therapeutic modalities are less likely to be effective in individuals who have difficulty adhering to behavioral determinants of diabetes self-management, because these problems are often beyond the reach and influence of physicians, dealing with medical treatment of persons with T2DM.
The application of questionnaires used in this study in the care of patients with T2DM, at all levels of health care, in initial stages or critical moments of disease, provides insight into their knowledge and attitudes about behavioral determinants of diabetes selfmanagement and timely detection of psychological conditions that affect them. This is the basis of the necessary multidisciplinary approach to patients with T2DM, which, by including other specialties (psychologists, nutritionists, physiotherapists), provide support to patients through education, motivation, behavior modification and psychological support. The results of conducted research indicate that is reasonable to expect that such a comprehensive approach contribute to better metabolic control of patients with T2DM.
The study results indicate that longitudinal research is needed in order better understand the impact of research determinants and evaluate the effectiveness of a multidisciplinary approach in achieving better metabolic control of patients with T2DM. This is basic recommendation for future research.