Factors associated with Glycemic control among Syrian patients with Type 2 Diabetes Mellitus

 

Khadija Khalil¹, Afraa Zrieki²

¹Master Student in Pharmacology Department, Faculty of Pharmacy, Tishreen University, Latakia, Syria.

²Doctor in Pharmaceutics and Pharmaceutical Technology Department,

Faculty of Pharmacy, Tishreen University, Latakia, Syria.

 

ABSTRACT:

Glycemic control is the main therapeutic objective in diabetes management. The aim of this study was to determine factors associated with poor glycemic control among Syrian patients with Type 2 diabetes mellitus (T2DM) in Latakia city. A random sample of 214 patients was selected from T2DM patients seen in the national center for diabetes in latakia over a period of 10 months in 2018/2019. Each patient was interviewed according to a validated questionnaire. Glycosylated hemoglobin (HbA1c) was measured for all patients using fast ion-exchange resin separation method. The SPSS 26.0 program was used for the statistical analysis. Probability (P) value less than 0.05 was considered statistically significant. Uncontrolled HbA1c (>7%) was seen in 70.6% of T2DM patients. There was no relationship of glycemic control, neither as HbA1c value, nor as percentage of patients with uncontrolled HbA1c, with age, gender, family history, education, duration of diabetes, diet or physical activity. Smokers and divorced patients, were more likely to have poor glycemic control. Elevated total cholesterol was significantly correlated with poorer glycemic control. Moreover, high levels of HbA1c were associated with the presence of diabetes complications and insulin therapy. Our findings suggests that poor glycemic control is common in T2DM Syrian patients in Latakia. Diabetic patients should routinely perform HbA1c and lipid profile analysis. There is a great need to educate patients about strategies to help them manage their diabetes and live a healthier life.

 

 

 

1. INTRODUCTION:

Diabetes mellitus (DM) is a group of metabolic disorders characterized by high levels of blood glucose due to defects of insulin secretion, insulin action, or both^1-3. DM is considered a global health problem, as it spreads rapidly around the world. According to the International Diabetes Federation, approximately 415 million person had diabetes in 2015, and this number would reach 642 million by 2040⁴. The number of deaths due to diabetes in 2016 was estimated at 1.6 million, according to the World Health Organization (WHO)⁵.

 

 

Hyperglycemia can cause damage to a large number of organs and tissues in the body, and that is related significantly to complications of diabetes, including neuropathy, retinopathy, nephropathy, foot ulcers and cardiovascular disease⁶. These complications may be delayed or slowed down and the quality of life improved by controlling blood glucose^7,8. HbA1c test is the gold standard test for monitoring glycemic control, it reflects mean blood glucose levels over a 2-3 month period⁹. Several studies have shown that increased HbA1c values ​​are associated with chronic complications of diabetes, and suggested the possibility of preventing complications, by moving from bad glycemic control to good glycemic control ¹⁰.

 

The American Diabetes Association (ADA) recommends to perform HbA1c test routinely for all diabetes patients at the beginning of the treatment evaluation, and then as part of the ongoing monitoring of the patient's condition. The ADA recommends to obtain HbA1c levels less than 7% as a goal of good glycemic control¹¹.

 

There are many factors that could be associated with glycemic control. These factors differ between countries, cultures and races, thus many studies have addressed this issue worldwide.

 

Therefore, in this study we aimed to evaluate the percentage of patients with Type2 diabetes who have HbA1c >7% in a population of T2DM patients attended the NCDL, and to investigate factors that could be related to HbA1c level.

 

2. MATERIALS AND METHODS:

A cross-sectional study was carried out at the NCDL between July 2018 and April 2019. Two hundred and fourteen patients, aged 18 years or more, had been previously diagnosed with T2DM by a qualified healthcare professional, were included in this study. The exclusion criterion included patients with type 1 diabetes mellitus; patients with gestational diabetes; and patients newly diagnosed with T2DM on the day of survey.

 

Each patient was interviewed and data were collected according to a previously validated questionnaire^12,13. The questionnaire included socio-demographic health risk variables (age, sex, marital status, educational level, smoking history, family history, duration of diabetes, presence of other comorbidities), anthropometric variables (body mass index (BMI), lipid profile), adherence to self-care behaviors (following meal plan, exercising regularly, testing blood glucose at home, adherence to medication ) and treatment modality.

 

BMI was calculated using the equation: BMI= weight (kg)/height (m²), and divided into 4 categories according to WHO criteria¹⁴: underweight (BMI is <18.5kg/m2), normal weight (BMI is between 18.5-24.9kg/m²), overweight (BMI is between 25-29.9kg/m²) and obese (BMI is ≥30kg/m²). Triglyceride (TG) and total cholesterol (TC) were divided into two categories: TG value ≤ or >150mg/dl and TC value ≤ or >200mg/dl. Blood pressure (BP) was measured in the right upper arm in the sitting posture, after a 10 min of rest. High adherence to medication (percentage of time patient took his medication over the past month) was defined as 99% to 100%¹².

 

Glycemic control was determined by HbA1c levels, which was measured for all patients in one laboratory using the same measurement tool depending on fast ion-exchange resin separation method¹⁵. Patients were subdivided, according to the HbA1c cutoff values suggested by ADA, into good glycemic control (HbA1c ≤7%) and poor glycemic control (HbA1c >7%)¹⁶. ^`

 

Statistical analysis was carried out using Statistical Package for Social Sciences (SPSS, version 26). Data were described using mean (±SD) for continuous variables and percentages for categorical variables. HbA1c is the main dependent and outcome variable, and it was tested for the association with other independent variables. Chi-square and ANOVA test were used to test the relationship between variables. Pearson’s correlation coefficient (r) was used to analyze the association between two variables. Probability (P) value was considered statistically significant when it was less than 0.05.

 

3. RESULTS:

3.1. Glycemic control:

Figure 1 shows the percentage of patients with poor glycemic control. Of the total 214 patients, 70.6% had a poor glycemic control (HbA1c ≥7%) (figure1, A). For more determination of glycemic control degree, patients were distributed into four groups: excellent control (HbA1c = 4.5-6.5%), well-control (HbA1c = 6.6-7%), acceptable control (HbA1c = 7.1-8%), and bad control (HbA1c > 8%) according to the recommendations of the ADA [73]. We noticed that about half of patients (48.60%) were in bad control category (Figure 1, B).

 

Figure 1: Patients distribution according to glycemic control level

 

3.2. Factors associated with poor glycemic control:

3.2.1. Sociodemographic and health risks factors:

Table 1 shows the percentage of patients with poor glycemic control (HbA1c ≥ 7%), and mean HbA1c values (mean±SD) stratified according to sociodemographic and health risks factors. For 214 patients included in this study, the mean age was 58.36 (SD = 9.96) years and ranged from 30 to 88 years. Ninety-nine patients (46.3%) were male, and 115 (53.7%) were female, 168 (78.5%) were married. About (29.4%) of patients had attained university level, 26.2% had attained primary school education, and (20.1%) were illiterate.

 

There was no statistical difference in HbA1c values or percentages of patients with poor glycemic control according to age categories, sex, or educational level. Concerning marital status, we did not find a statistically significant difference in percentage of patients with poor glycemic control between the four categories (single, married, divorced, and widowed). However, when comparing the means of HbA1c values among these groups, the divorced patients had the highest HbA1c value (13.35%), while the lowest value was among married couples (8.29%) with a statically significant difference (p = 0.003).

 

Regarding the health risk variables, the percentage of smokers was (47.7%) and non-smokers was (52.3%) in our population. We found that smokers were more likely to have poor glycemic control (78.4%) compared to nonsmokers (63.4%) (p=0.001), but without significant difference between the mean HbA1c values.

The mean duration of diabetes was 10 years, and it ranged between >1 and 34 years. About 66.3% of patients reported to have a positive family history of diabetes from either first-degree or second-degree relatives or from both. No difference was found in percentage of patients with poor glycemic control or mean HbA1c values according to duration of diabetes or presence of family history.

 

Out of 214 patients, 74(34.6%) had one diabetic complication and 20(9.3%) had ≥2 complications. The majority of patients, 43(20.1%), were suffering from cardiovascular disorders. Patients with retinopathy accounted for 30 (14.01%), while 27(12.6%) patients were suffering from peripheral neuropathy. Patients with nephropathy accounted for 8(3.7%), and 8(3.7%) patients had foot ulcers. Patients without complication accounted for 120(56.1%) patients. Poorly controlled diabetes was more frequent among patients with two complications (90%) in comparison to those with one complication (74%) or no complication (65%), the difference was at the limit of statistical significance (p=0.052). However, the mean value of HbA1c was significantly higher (9.68%) in patients with two complications compared to other categories (p=0.014). Furthermore, the percentage of patients with poorly controlled diabetes did not differ significantly according to the type of diabetes complication. However, the mean value of HbA1c was significantly higher in patients with neuropathy, nephropathy, or foot ulcer compared to patients without these complications.

 

Table 1: Percentage of patients with poor glycemic control and mean HbA1c levels according to Sociodemographic and health risks factors

 

Table 2: Percentage of patients with poor glycemic control and mean HbA1c levels according to Anthropometric variables

 

Table 3: Percentage of patients with poor glycemic control and mean HbA1c levels according to Self-Care Behavior’s Performance

 

3.2.2. Anthropometric variables:

The BMI of our study population ranged from 17.19 to 44.82kg/m² with a mean ±SD of 29.91±5.13kg/m². As shown in table 2, there was no statistically significant difference neither in the mean HbA1c values nor in the percentage of patients with poor glycemic control according to BMI categories, noting that the percentage of patients with poor glycemic control exceeded 65% for all categories of BMI.

 

Concerning the lipid profile, TC analysis was performed for 119 patients and TG analysis for 81 patients. The mean blood TC value was 180.55±47.62, with a range of 77 to 339mg/dL. The mean TG value was 175.05± 103.64 with a range of 46 to 752mg/dL. Once more, we did not observe any significant difference in diabetes control according to TC or TG categories neither as percentage of patients with poorly controlled diabetes, nor as the mean value of HbA1c. To more clarify our results, we also studied the correlation between HbA1c values and each of TC and TG levels as continuous values. Pearson correlation coefficient did not reveal any statistically significant correlation between HbA1c and TG levels, (r = 0.09, P = 0.423). However, we observed a poor but significant positive correlation between of HbA1c and TC levels, as HbA1c level increased with the increase of TC level (r = 0.194, P = 0.034), (data not shown).

 

3.2.3. Self-Care Behavior’s Performance:

About 50.9% of patients did not follow diabetic meal plan as recommended by the doctor, and 59.3% did not participate in physical exercise. Only 20.1% of patients used to test their blood sugar at home. More than half of patients (58.9%) were not adherent to their medications. Self-Care Behavior did not significantly affect the degree of glycemic control. Neither HbA1c value nor percentage of patients with poor glycemic control were associated with higher adherence to following recommended meal plane, doing exercise, or testing blood glucose at home. However, when we investigated the relationship between glycemic control and adherence to hypoglycemic treatment, we found that patients with higher adherence to medication had lower HbA1c value (7.49%) compared to not adherent patients (9.09%), (P=0.039), and the percentage of poor glycemic control was lower as well (48.9% vs 85.9% respectively, P<0.0001) (Table 3).

 

3.2.4. Medications:

There were 178 (83.2%) patients used oral hypoglycemic agents (OHA) to manage diabetes and 17 (7.9%) had a history of using combination therapy (insulin and oral hypoglycemic drug), 19(8.9%) had used only insulin.

 

 

We compared mean HbA1c values and percentage of patients with poor glycemic control between patients taking one modality of treatment with patients not taking this modality. There was statistically significant difference in mean HbA1c values between patients treated with metformin (7.73±2.18) and other patients not receiving this antidiabetic drug (8.61±2.09) (p< 0.001). In addition, poor glycemic control was more frequent in patients not receiving metformin (76%) compared to metformin group (48.4%) (p=0.015). We also found statistically significant difference in mean HbA1c values between patients treated (9.65±2.51) or no (8.31±2.06) with insulin (p=0.009). However, with other treatment modality seen in our population: gliclazide, metformin+gliclazide, metformin+gliclazide +sitagliptin, insulin+metformin, or insulin+metformin +sitagliptin,  we did not observe any statistically significant difference between patients receiving or no one of these modalities of treatment. When comparing all types of treatment, patients treated with insulin showed the highest percentage of poor glycemic control (89.5%) and mean HbA1c value (9.65), while patients treated with metformin or gliclazide had mean HbA1c values near to recommended level (7.73) and (7.76) respectively.

 

Table 5: Percentage of patients with poor glycemic control and HbA1c levels according to treatment modality

 

4. DISCUSSION:

Diabetes mellitus is a worldwide health issue. Achieving HbA1c target of <7% has been shown to reduce complications of type 1 and type 2 diabetes when instituted early in the course of disease^10,17.

 

Despite the importance of glycemic control in diabetes management, the majority of patients did not achieve the recommended HbA1c levels in our study population, we found a high prevalence (70.44%) of poor glycemic control defined as (HbA1c >7%) with mean±SD HbA1c of 8.44±2.13. This finding was comparable to the percentage of patients with poor glycemic control seen in previous studies conducted in Saudi Arabia, (74%)¹³, Venezuela¹⁸, (75%), and India (78.6%)¹⁹.

 

This high prevalence of poor glycemic control in our country may be a result of poor conditions of life during the years of the war that has been lasting more than 10 years, preventing patients from following health instructions, and limiting the ability of health care staff to provide necessary guidance to diabetic patients.

 

Most studies identified the socio-demographic characteristics associated with glycemic control to include age, gender, educational level, family history, employment status, and socio-economic status²⁰. In our study, we did not find any association between age and glycemic control. El-Kebbi et al. found an association between younger patients and poor glycemic control. They explained that the older patient may have better access to medical care, or may be more motivated in taking care of their diabetes and more compliant with their diet and medications²¹.

 

Gender may have an effect on glycemic control, but in our study the data showed that no difference in glycemic control between males and females. This finding comes in agreement with other studies^13,22. However, the study of Haghighatpanah et al. showed that male patients had better glycemic control while females are more at risk of poor glycemic control, especially among women who are responsible for taking care of the family, which leads to neglecting their health²³.

 

In our study, no association was found between education and glycemic control. Similar findings have been reported by Kamuhabwa et al.²⁴. In contrast, the study of Mamo et al. showed that uneducated patient had poor glycemic control²⁵. Concerning marital status, we found that divorced subjects had a higher HbA1c; the pressures faced by the divorced person and the poor psychological state caused by separation, especially if there are children, could explain this result. However, It should be noticed that the number of divorced subjects in our study is small (only two patients).

 

Smoking is a risk factor for type 2 diabetes²⁶. In our study, smokers showed higher percentage of poor glycemic control. The study of Badedi et al. showed that smokers were significantly more likely to have higher HbA1c compared to nonsmokers¹³. Some studies have shown increased insulin resistance in association with cigarette^27,28, the mechanism is still unclear²⁹.

 

In the present study, we found no association between family history and glycemic control. The study of Awwad et al. showed a similar result³⁰. However, a study in Urban African Americans revealed a positive parental history to be associated with worse glycemic control³¹.

 

Contrary to the most of present literature, duration of the disease did not show statistical significance for association with glycemic control. This result could be explained by the dominate effect of other factors related to disease process, which has probably masked the effect of time, noting that our population had already a long duration of diabetes with a mean of 10 years.

 

Previous studies have shown strong and statistically significant association between glycemic control and the risk of cardiovascular disease morbidity and mortality, and microvascular complication of diabetes¹⁰ We found that patients who had cardiovascular disease, neuropathy, nephropathy, or foot ulcer, or had more than one complication, were more likely to have poor glycemic control. These findings, which are comparable to previous studies^25,32, ensure the necessity of good glycemic control to minimize or delay diabetes complications.

 

Obesity was shown to increase the odds of developing many common diabetic complications, including heart disease, retinopathy, dyslipidemia, and hypertension^1,33. However, our study did not show any association between BMI and glycemic control. It is important to notice that in our T2DM population, the BMI was ≥25kg/m² in more than 80% of patients. The greater number of patients gathered in the overweight and obesity groups may be the reason of masking the significant difference in mean HbA1c value between the four BMI groups.

Dyslipidemia is common in individuals with T2DM. The absence of relationship between poor glycemic control and triglycerides values in our study may be due to the small number of patients for whom TG analysis was done (81 patients). Inconsistently with our result, the study of Goudswaard et al. demonstrated that higher values of TG were associated with poor glycemic control³⁴. Regarding TC level, there was a positive correlation between overall continuous plasma TC and HbA1c values. A study by VinodMahato et al. revealed the presence of significant correlations between HbA1c and each of TC, LDL-C and LDL-C/HDL-C ratio³⁵. It is possible that many factors are responsible for diabetic dyslipidemia including the effect of insulin on liver apoprotein production, the role of insulin on the regulation of lipoprotein lipase (LpL), in addition to peripheral actions of insulin on adipose tissue and muscle,³⁶. The net of these factors could differ according to study population.

 

Prior to the discovery of insulin, diet and exercise were the principal therapies used in the treatment of diabetes mellitus^37-38. Despite the beneficial effects of exercise and diet, and contradictory to several past studies that have linked physical activity to low glucose level, we found no association of diet and physical activity with glycemic control in our population. The study of Badedi et al. also showed that physical activity did not play a significant role in glycemic control. In our study, the absence of the effect of diet and physical activity on glycemic control could be explained by the fact that the majority of patients had a value of HbA1c >8%, with this value the diet and physical activity are no longer sufficient to control glucose level. In addition, our study depends only on observation, we did not put the patient on a diet plan or exercises. All these factors may affect the outcome.

 

Moreover, our study did not show a statistically significant difference in glycemic control with or without testingblood glucose at home. Mamo et al. found that the fact of not self-monitoring blood glucose was significantly associated with poorer glycemic control²⁵. In our study, most of patients did not have a glucose meter or strips due to the high price of these tools.

 

Poor adherence to medication was associated with higher HbA1c level; patients who were less adherent to medication also had a greater percentage of poor glycemic control. This finding was comparable to previous studies³⁹.

 

Drug intake is one of the most important factors in glycemic control⁴⁰. We found that patients treated with metformin had significantly lower levels of HbA1c followed by patients treated with gliclazide. Patients treated with insulin or multiple antidiabetic drugs had higher levels of poor glycemic control. This can be explained by the fact that diabetes in its early stages is easy to be controlled using a single treatment, usually metformin or gliclazide. As the disease progresses, insulin and more than one OHA are usually needed. Failure to improve glycemic control by prescribing insulin and more than one OHA in our study may be explained by the difficulty of adherence to treatment with the increase in the number of drugs, besides the feeling of fear of insulin injections or the wrong injection method. This result is consistent with other studies. Chiu et al. showed that participants who used insulin alone or in combination with oral medications had higher HbA1c levels than participants treated only with diet or oral medications⁴¹. Therefore, patients must be educated about the necessity of combining drug therapy, diet and exercise to encourage them to achieve optimal glycemic control and avoid diabetes complications that limit their quality of life⁴².

 

5. CONCLUSION:

Our study has revealed that poor glycemic control is prevalent in T2DM subjects in Latakia, Syria (70.6%), which emphasize the need for routine screening for HbA1c levels. Factors associated with poor glycemic control included smoking, divorce, presence of diabetes complications, and treatment type (insulin or combination of insulin+OHA). A small number of patients follow the instructions for self-care of diabetes, so it is necessary to create an educational program that focuses on the importance of adherence to medications, exercise and appropriate diet for diabetics. This could be useful in improving glycemic control, and thereby patient life quality.

 

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Accepted on 12.09.2021           © RJPT All right reserved

Research J. Pharm.and Tech 2022; 15(4):1701-1708.