Assessment of Risk Factors Associated with Type 2 Diabetes Mellitus in Central Zone of Tigray, North Ethiopia

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International Journal of Pharmaceutical and Biological Sciences Fundamentals, Vol. 07, Issue 01, October 2014 WWW..COM ISSN: 2278-3997 Assessment of Risk Factors Associated with Type 2 Diabetes Mellitus in Central Zone of Tigray, North Ethiopia T/Kiros Giday 1, Huruy Aseffa 2 and Abadi Kidanemariam 3 1 Urban health Extension program coordinator, Aksum town health office, Tigray, north Ethiopia tgiday2013@gmail.com 2 College Dean, Aksum Araya kahsu health Science College, Tigray, north Ethiopia abadik021@gmail.com 3 Huruy Assefa, Mekelle University college of health science, Tigray, north Ethiopia Abstract In the Introduction: Type 2 diabetes is a chronic metabolic disorder, in which the body is unable to utilize glucose from food due to insulin problems, and it accounts around 90 % of all diabetic cases. Globally, the prevalence of diabetes in 2010 among adults aged 20-79 years is estimated a 6.4%, affecting 285 million adults. In Ethiopia, the prevalence of adult diabetes is estimated 4.5 % with 1.9 million cases in 2013. Despite the fact that the prevalence and incidence of Type 2 Diabetes mellitus increases due to different factors, efforts has not been paid by health-care practitioners and policy makers on the prevention of type 2 diabetes. Therefore; this study aimed to assess the risk factors associated with type 2 diabetes. Objective: The objective of the study is to assess the risk factors associated with type 2 Diabetes mellitus in central zone of Tigray, North Ethiopia. Methods: Facility based Case control study was conducted using systematic random sampling technique. A sample of 73 cases and 290 controls were selected from all the three hospitals in central zone of Tigray using population proportion to size allocation. Structured questionnaire was used to collect data using face to face interview. Data were entered using Epi-info software. Data cleaning and analysis was done using SPSS version 20 computer software. Keywords: Mellitus, Tigray Descriptive statistics like frequency, mean, and median have been computed and presented using tables and texts. Bivariate logistic regression was used and variables statistically significant at p< 0.05 were taking to the multivariable logistic regression. Multivariable logistic regression was done to identify the risk factors associated with Type 2 DM. A P < 0.05 was considered significant for the analysis of this study. Results: The results of the study showed that; Smoking tobacco (AOR = 4.254, 95% CI = [1.159, 15.621]), Poor diet(aor = 7.044, 95% CI = [2.475,20.049]), Physical inactivity (AOR = 8.942, 95% CI = [2.866, 0.27.905]), Overweight/obesity (AOR= 9.608, 95% CI = [3.561, 25.924]) and hypertension (AOR = 5.938, 95% CI = 1 [2.134, 16.522]) were significantly associated with type 2 diabetes mellitus. Conclusion and Recommendation: Risk factors associated with type 2 diabetes mellitus was seen in behavioral and medical related factors. Policy makers, health professionals as well as the community in large should emphasis in primary and secondary prevention activities Key words: type two diabetic mellitus, risk factor, central zone, Tigray 1. Introduction 1.1. Back ground of the study Diabetes is a chronic disease that occurs when the body cannot produce enough insulin or cannot use insulin effectively. Insulin is a hormone produced in the pancreas that allows glucose from food to enter the body s cells where it is converted into energy needed by muscles and tissues to function (1). Type 2 diabetes is the most common type of diabetes (1). It can be linked to be accounting for around 90 % of all diabetic cases, in which the body is unable to utilize glucose from food (2). In type 2 diabetes, the body is able to produce insulin but either this is not sufficient or the body is unable to respond to its effects (also known as insulin resistance), leading to a build-up of glucose in the blood (1). The muscle and tissue cells become resistant to insulin, which results in glucose accumulation in the blood stream (3). It usually occurs in adults, but is increasingly seen in children and adolescents as well (1). Diabetes can be diagnosed on any of the following WHO criteria: Fasting plasma glucose (FPG) 7.0 mmol/l (126 mg/dl) or, 2 hour plasma glucose 11.1 mmol/l (200 mg/dl) or, Glycated haemoglobin (HbA1c) 6.5% / 48 mmol/mol, or Random plasma glucose 11.1

International Journal of Pharmaceutical and Biological Sciences Fundamentals, Vol. 07, Issue 01, October 2014 WWW..COM ISSN: 2278-3997 mmol/l(200 mg/dl) (4). Diabetes is now one of the most common non-communicable diseases globally. It is the fourth or fifth leading cause of death in most high-income countries (5). Approximately 5.1 million people aged between 20 and 79 years died from diabetes in 2013, accounting for 8.4% of global allcause mortality among people in this age group (1). There is substantial evidence that it is epidemic in many low- and middle-income countries (5) with an increasing proportion of affected people in younger age groups (4). Diabetes caused 522,600 deaths among people aged 20-79 years in the African Region in 2013 (6). Rapid uncontrolled urbanization and major changes in lifestyle could be driving this epidemic (7). In Ethiopia, 34,262 adults aged 20-79 years died from diabetes in 2013 (6). World Health Organization recommends, simple lifestyle measures are effective in preventing or delaying the onset of type 2 diabetes. People should: achieve and maintain healthy body weight; be physically active at least 30 minutes of regular, moderate-intensive activity on most days. More activity is required for weight control; eat a healthy diet of between three and five servings of fruit and vegetables a day and reduce sugar and saturated fats intake; avoid tobacco use (8). Early identification of potential complications can provide opportunities for intervention, education, and referral to a specialist when necessary (9). 1.2. Statement of the Problem The world prevalence of diabetes in 2010 among adults aged 20-79 years is estimated to 6.4%, affecting 285 million adults. Between 2010 and 2030, there is an expected 70% increase in numbers of adults with diabetes in developing countries and a 20% increase in developed countries (10). It has been described as a killer disease in so many situations. It is now ranked among one of the most common noncommunicable diseases in the world. It falls within 4th 5th leading cause of death in most developed countries and there are facts and figures that it is epidemic in many developing and newly industrialized countries (11). The number of people with Type 2 diabetes is growing rapidly worldwide. This rise is associated with economic development, ageing populations, increasing urbanization, dietary changes, reduced physical activity, and changes in other lifestyle patterns (1).The global epidemic of type 2 diabetes mellitus grossly affects indigenous and developing populations (12). Many patients with diabetes mellitus are unaware that they have diabetes mellitus and type 2 diabetes mellitus may be present for up to a decade before diagnosis. Many patients with type 2 diabetes mellitus have one or more of 2 diabetes mellitus related complications at diagnosis. It is recommended to screen those at risk of developing diabetes mellitus using fasting blood glucose (FBS). The morbidity and mortality of diabetes mellitus related complications can be greatly reduced if detected and treated at an early stage (13). The prevalence of Type 2 diabetes varies widely between population, reflecting differences in both environment influences and genetic susceptibility. A number of risk factors are attributed to the incidence of type 2 diabetes, including family history, age, and social group characteristics, behavioral and lifestyle, physiological and clinical factors (14). According to WHO, the prevalence of diabetes mellitus is increasing in developing countries due to sedentary lifestyles, aging, unhealthy diets (15). In Africa, Currently an estimated 19.8 million adults have diabetes with a regional prevalence of 4.9%. The ranges of prevalence between countries reflect the rapid socioeconomic and demographic transitions faced by communities throughout the Region. The highest prevalence of diabetes in the Africa Region is on the island of Reunion (15.4%), followed by Seychelles (12.1%), Gabon (10.7%) and Zimbabwe (9.7%). Some of Africa s most populous countries have the highest numbers of people with diabetes, including: Nigeria (3.9 million), South Africa (2.6 million), Ethiopia (1.9 million), and the United Republic of Tanzania (1.7 million). More than half of all people with diabetes in the Region live in just four of these high-population countries (1). In sub- Saharan Africa, growth rates of diabetes mellitus (DM) is among the highest worldwide. While today an overall DM prevalence of 4% is assumed, the number of affected patients is projected to double from 12 to 24 million within the next 20 years (7, 16). DM and other chronic diseases hit Africa in particular due to different reasons. The health system does not reach a considerable portion of the population, has a focus on emergencies and infectious diseases, and is frequently limited in staff and infrastructure. Health workers lack often sufficient training in chronic disease management (16). In Ethiopia, International diabetes federation estimates the number of adult diabetic cases to be 1.9 million with national prevalence of 4.5 percent in 2013 (1). National data on prevalence and incidence of diabetes are lacking. However, patient attendance rates and medical admissions in major hospitals are rising (17). Despite the fact that the prevalence and incidence of Type 2 Diabetes mellitus increases due to population growth, aging, urbanization, and increasing prevalence of obesity and physical inactivity, efforts has not been paid by health-care practitioners and policy makers on the prevention of

International Journal of Pharmaceutical and Biological Sciences Fundamentals, Vol. 07, Issue 01, October 2014 WWW..COM ISSN: 2278-3997 the risk factors of type 2 diabetes and no published studies have been conducted on the risk factors in Tigray region and as well as in the study area. Understanding the risk factors of Diabetes Type 2 and the people affected, now and in the future, is important to allow rational planning and allocation of resources. Therefore; this study aims to assess the risk factors associated with Type 2 Diabetes mellitus in central zone. 1.3. Significance of the Study Type 2 diabetes mellitus is currently increasing due to different factors in Ethiopia. This can be prevented by improving healthy life styles. Assessing the risk factors associated with type 2 diabetes mellitus maximize the efforts on the prevention mechanisms to solve the problems. This study was aimed to provide information for health professionals, policy makers and other governmental and Nongovernmental organizations to maximize efforts on the prevention of type 2 Diabetes mellitus in the country as well as in the study area. 2. Literature Review 2.1. Socio demographic related Factors According to International Diabetes federation (IDF) Atlas 2013, Type 2 diabetes accounts for 85% to 95% of all diabetes in high-income countries and may account for an even higher percentage in low- and middle income countries. Type 2 diabetes is a common condition and a serious global health problem. In most countries diabetes has increased alongside rapid cultural and social changes: ageing populations, increasing urbanization, (1). Rapid increase in both the prevalence and incidence of type 2 diabetes has occurred globally with significant increase, in societies in economic transition (18). Almost half of all adults with diabetes are between the ages of 40 and 59 years. More than 80% of the people with diabetes in this age group live in lowand middle-income countries (1). Low education associated with Type 2 diabetes (19, 20). A 3 year follow up study in Denmark on the risk factors of type 2 diabetes shows that, the most important known non-modifiable risk factors are ageing, heredity (21). Studies in Northern Nigeria and Sub-Saharan Africa, The increase in type 2 diabetes mellitus in Africa has been attributable in part to urbanization and urban residence (22, 23). In Nigeria, the prevalence and risk factors of adult Diabetes study shows Age (OR = 1.053, 95% CI: 1.007-1.102), social class, and 3 Ethnicity was significantly associated with type 2 Diabetes. This study shows the association of each risk factor with adult diabetes in Nigeria. Diabetes was more frequent in people aged 50 years and social class, Subjects in the highest socioeconomic class showed significantly higher prevalence of type 2 diabetes when compared with the others, Diabetes was more prevalent in the Ibibio and Hausa_/Fulani subjects than the other ethnic groups (24). In Ethiopia, A community based study in Jima town shows that the prevalence of type 2 diabetes was 5.3% and significantly associated with age (8.2%), those who have middle income(11.2%), male in sex (9.2%) and over weight (12.6%), (P< 0.05) (25). 2.2. Behavioral related Factors Studies from England and Asia have elaborated the associations between several risk factors and the risk of type 2 diabetes. Smoking, physical inactivity, and dietary patterns, are the most frequently documented risk factors for type 2 diabetes (19, 20). A study in Denmark on the risk factors of type 2 diabetes also shows that, the most important modifiable risk factors are obesity, dietary factors, physical inactivity, smoking, and alcohol consumption (21). The increase in type 2 diabetes mellitus in Africa has been attributable in part to sedentary lifestyle, behavioral habits, physical inactivity, low intake of fruits and vegetables, high intake of animal fat and protein, and lifestyle changes (22, 23). The prevalence and risk factors of type 2 Diabetes in Nigeria study shows, Physical inactivity, family history of diabetes, Alcohol intake was significantly associated with type 2 Diabetes. Subjects who drank more than 21 units of alcohol per week were more likely to have diabetes than those who drank moderately (24). Physical activity has been identified as an integral part in primary prevention of type 2 DM in high risk people and in secondary prevention of associated complications in people already diagnosed with diabetes. Physical activity contribute to improve insulin sensitivity, decrease blood glucose and blood pressure level, weight loss, reduce triglycerides and cholesterol, increase muscle tone, improve circulation, stress relief and well being feelings (26). Heavy drinking has been implicated as a risk factor for type 2 diabetes (27). In the majority of prospective studies, heavy drinkers have higher risk than light/moderate drinkers and in many studies heavy drinkers have the highest risk. In the Paris Prospective Study, persons with diabetes had a higher risk of death by cirrhosis, which was strongly associated with alcohol consumption (28). An increased risk of diabetes was found in men who

International Journal of Pharmaceutical and Biological Sciences Fundamentals, Vol. 07, Issue 01, October 2014 WWW..COM ISSN: 2278-3997 drank >21 drinks/week when compared with men who drank 1 drink/week (OR = 1.50, 95% CI: 1.02, 2.20) while no significant association was found in women. The relative odds of incident diabetes in a comparison of men who drank >14 drinks of spirits per week with men who were current drinkers but reported no regular use of spirits, beer, or wine were 1.82 (95% CI: 1.14, 2.92). Results of this study support the hypothesis that high alcohol intake increases diabetes risk among middle-aged men (29). The resent study from Bishoftu, Ethiopia indicates that frequent drinkers were 4.54 times affected by diabetes than moderate drinkers (OR = 4.54, 95% CI: 1.29-15.96) (30). Studies also reported that current smoking is a risk factor for developing type 2 diabetes mellitus (31). A meta- analysis including 25 prospective studies showed that current smoking was associated with a 44% increased risk of diabetes. The association between smoking and type 2 diabetes mellitus was stronger for heavy smokers > 20 cigarettes/day compared with light smokers or former smokers (32). Other case control study in India shows that tobacco use and physical activity was significant factors; and individuals who use tobacco were 2.49 times more likely to develop type 2 diabetes mellitus than who do not use tobacco (OR = 2.49, 95% CI: 1.22-5.15) ( 35). 2.3. Bio-medical related Factors Overweight/ obesity in BMI, hypertension, and family history, are the most frequently documented risk factors for type 2 diabetes (19, 20). The increase in type 2 diabetes mellitus in Africa has been attributable in part to obesity, systemic arterial hypertension (22, 23). A study in Ghana shows the factors independently associated with type 2 Diabetes included a diabetes family history (OR= 3.8; 95% confidence interval (95%CI), 2.6-5.5 (33). Similar study in Kenya, hospital based case control study on risk factors of type 2 diabetes among diabetic clients show that family history of Diabetes (RR=2.2, P= 0.0131) and obesity (RR = 2.0, p = 0.0010) identified as independent risk factors for type 2 diabetes in the study (34). A study in Nigeria shows that the prevalence and risk factors of adult Diabetes was significantly more prevalent in people with a family history of diabetes 9.45 times more likely to develop Type 2 DM compared with those without a family history (OR = 9.45, 95% CI: 3.499-35.539) (24). A case control study from India in 2013 shows that Systolic blood pressure was 4.69 higher the risk factor for the development of type 2 DM ( OR= 4.69, 95% CI of 2.13-10.40 (35). A Study from Ethiopia also shows that the risk factors of adult Diabetes mellitus associated with history of hypertension (13.51%) OR: 4.75, CI 95% (1.94-11.67) (30). Over 80 % of people with Type 2 diabetes are overweight or obese (36). The probable cause of obesity in developing countries has been attributed to the current lifestyle, where urbanization, better economic development and an increase in income have resulted in diet changes and less physical activity. Obesity increases the risk of developing type 2 diabetes mellitus (37), and results from an imbalance between excessive calorie consumption and low physical activity. The link between obesity and Diabetes development was through insulin resistance caused by fatty tissue followed by progressive beta cells failure because forced to increase amount of insulin blood glucose then accumulates and induced apoptosis of beta cells, insulin deficiency will occur and diabetes comes as a diagnosis (38). Overweighed subjects showed 4.32 more common undiagnosed diabetes mellitus than subjects with normal BMI [OR=4.32, 95% CI: 1.58-11.81] (30). 2.4. Conceptual Framework of the Study The study was assessed the risk factors of type 2 Diabetes mellitus. Variables were selected based on the reports of different literatures. Sociodemographic factors, Behavioral factors, Bio medical factors and the outcome variable type 2 Diabetes focused on this study. 4

International Journal of Pharmaceutical and Biological Sciences Fundamentals, Vol. 07, Issue 01, October 2014 WWW..COM ISSN: 2278-3997 Socio demographic factors Age Sex Education Place of residence Marital status Ethnicity Income Behavioral factors Frequent alcohol Consumption Cigarette smoking Physical inactivity Poor diet Biomedical Factors Overweight /Obesity/ History of hypertension Family history of Diabetes Outcome variable Type 2 diabetes mellitus Figure 1.A Conceptual framework developed from different literature reviews. 3. Objectives 3.1. General objective The general objective of the study was to assess the risk factors associated with type 2 Diabetes mellitus in central zone of Tigray, North Ethiopia. 3.2. Specific objective To identify factors associated with type 2 Diabetes mellitus in central zone, North Ethiopia. 5

International Journal of Pharmaceutical and Biological Sciences Fundamentals, Vol. 07, Issue 01, October 2014 WWW..COM ISSN: 2278-3997 To assess anthropometry associated with Type 2 Diabetes Mellitus in central zone of tigray, North Ethiopia 4. Methods and Materials 4.1. Study Area and Period The study was conducted in central zone, Tigray region which is located in northern part of Ethiopia, which is 1,245 km from Addis Ababa and 235 km from Mekelle to the Administrative city of central zone. The zone includes 9 district woredas and 3 urban woredas, the total population is estimated to be 1,131,697 according to the 2007 population and house hold survey. The estimated population consisted of 576,367 females (51%), 556,330 males (49%), (39). Moreover, central zone has 2 District, one zonal governmental hospital, and 57 health centers. There are 3 governmental hospitals who give chronic care services including Diabetes mellitus. There is no health center that gives Diabetes mellitus care follow up in the study area. According to the hospital reports in the study area, there are currently 817 type 2 diabetic patients on follow up in the study area. The study was conducted from February to March, 2014 in central zone. 4.2. Study Design Facility based case control study was conducted 4.3. Population 4.3.1. Source population The source population of the study was adults with Type 2 diabetic mellitus and without diabetic mellitus clients in central zone. 4.3.2. Study Population The study population were sample of adults with type 2 diabetic mellitus who have follow-ups and without diabetic mellitus clients who were visitors and care givers at the data collection period in central zone. 4.3.3. Study unit Selected individuals with type 2 Diabetic mellitus who have follow-ups and without diabetes mellitus who were visitors and care givers at the data collection period in the study area. 6 4.4. Inclusion criteria and Exclusion criteria 4.4.1. Inclusion Criteria Cases (Type 2 Diabetic patients who have follow-ups) and controls (without diabetes who were patient visitors and care givers) aged 20 years in the study area were included and, Individuals who are permanent (>6 month) residence in the study area 4.4.2. Exclusion Criteria Type 2 Diabetic patients who were critically ill and unable to communicate in the study period were excluded from the study. Type 2 Diabetic patients who were not volunteering for the study were excluded from the study. Pregnant women were excluded from the study. Individuals with known communicable and non communicable disease were excluded from the control study subjects in the study period. 4.5. Sample size Determination and Sampling Strategy 4.5.1. Sample size Determination The sample size was determining by using Open EPI- INFO software to estimate the sample size required for the study. A 95% confidence level and 80% power was using to detect OR= 2.49 with prevalence exposure of controls 18.5%. Tobacco use was using as exposure variable (35). The population for this study consisted of sampled cases and controls of adults who have follow ups in the study area. The ratios of cases to Controls were 1:4 and the final estimated sample size was 66 for cases and 261 for controls which is 327. For the non response rate 10% was added to give a total sample size of 73 cases and 290 controls. 4.5.2. Sampling Procedure The study was conducted using systematic random sampling technique. All the three hospitals found in Central zone of Tigray were included in the study. Cases were selected from the outpatient department of the hospitals, and Controls who were non diabetic study subjects were selected from the visitors and care givers at the data collection time in the study

International Journal of Pharmaceutical and Biological Sciences Fundamentals, Vol. 07, Issue 01, October 2014 WWW..COM ISSN: 2278-3997 area. Screening has been carried for the non diabetic study subjects by determining either Fasting plasma glucose or Random plasma glucose. One record of fasting plasma glucose (FPG) <7.0 mmol/l (126 mg/dl) or, Random plasma glucose <11.1 mmol/l(200 mg/dl) (4) was considered to select the controls. The number of study units to be sampled from cases and controls were selected using population proportion to size allocation and, systematic random sampling was employed to select each study subjects. Every 6 th sampling fraction was used to determine the study subjects after taking the preliminary data. Based on the sampling fraction a starting client was determined by using simple random sampling techniques. When an individual does not satisfy the inclusion criteria, the next participant was included in the study. 4.6. Data collection Procedure Quantitative primary data have been collected using structured pre-tested questionnaires by using face to face interviews in areas where the privacy of the clients maintained. The questionnaire was including socio demographic and economic conditions, Behavioral factors, biomedical, and physical measurements were applied for weight and height to calculate BMI. The questionnaire was adapted from WHO step wise approach for non communicable disease surveillance (40) by considering the national situations of the study subjects. This was initially prepared in English and then translated in to Tigrigna version. The Tigrigna version again translated back to English to check for consistency of meaning. Five nurse data collectors and 2 nurse supervisors were employed in the data collection process. Training was given by the principal investigator for two consecutive days to have enough knowledge on the techniques, ethics of data collection, quality and completeness of the data collection process. Data collectors and supervisors were assigned to the three hospitals in Central zone, and the data collection process was taking one month. Participants who were not interested to provide information at the time of data collection were considered as non-response. 4.7. Study Variables 4.7.1. Outcome Variables Type 2 Diabetes Mellitus 4.7.2. Independent Variables Socio economic factors 7 Age, Sex, Place of residence, Religion, Ethnicity, marital status, Level of education, Occupational status, Monthly Income Behavioral factors Physical activity, Smoking, diet habits, Alcohol consumption Biomedical factors Family history of DM, History of hypertension, Obesity (overweight) 4.8. Operational Definitions Physical activity: Clients, who had practiced any regular physical activity per week, It is categorized as active those who practiced >300 minutes moderate physical activity, moderately active those who practiced 150-300 minutes moderate physical activity like fast walking and swimming per week, physically inactive less than 150 minutes per week including for those in sedentary life style or its equivalent vigorous physical activity. Smoking: smoking habit was assessed as Ever smoking (current + previous smoking) as well as current smokers, previous smokers and Non smokers regardless of the amount and frequency of use. Alcohol users: Ever drinking alcohol regardless of the amount and frequency of use. This was categorized as Heavy drinkers for those who drink > 21units/week, Moderate drinkers 14-21 units/week, and less drinkers for those who drinks < 14 units/week (29). Body mass index (Kg/m 2) : Body mass index (BMI) is used to measure whether or not clients have healthy weight or underweight, overweight or obese. Height was measured by using a stadiometer, standing upright on a flat surface. Body weight was measured while wearing light clothes by an adjusted scale. Body mass index (BMI) was calculated by the formula: weight in kilograms divided by height in meters squared. In this study it is categorized as underweight (<18.5 kg/m 2 ), Normal (18.5-24.9 kg/m 2 ), overweight (25-29.9 kg/m 2 ), and obese (>30 kg/m 2 ) (41). Family history of DM Clients regarded as positive if either of parents, Sister or brother (s) have diabetes mellitus. Poor diet Those who do not eat fruits and vegetables in their diet, and categorized those who eat less than 3 daily servings of fruits and vegetables,

International Journal of Pharmaceutical and Biological Sciences Fundamentals, Vol. 07, Issue 01, October 2014 WWW..COM ISSN: 2278-3997 and good diet categorized according to the Dietary Approaches to Stop Hypertension (DASH) eating plan as individuals who eat fruits and vegetables > 3 servings per day (42). Hypertension defined as either systolic BP > 140 mmhg or diastolic BP >90 mmhg (42), two readings 5 minutes apart will be conducted and the mean BP was taken. Based on this finding, individuals who diagnosed positive for hypertension was considered positive for the history of hypertension. 4.9. Data Management and Analysis Data was entered using EPI- INFO version 3.5.1 computer software, and cleaning & analyzing were done by SPSS version 20.The raw data was handled carefully from loosing of available data using computer password. Data cleaning was performed by running frequency of each variable to check accuracy, inconsistency and missed value of the data. Before analysis of the data, recoding of variables was conducted to make easy for analysis. Descriptive statistics like frequency, Mean with standard deviation for normally distributed data and median with inter quartile range for non-normally distributed data to all variables which were related to the objective of the study was computed and have been presented using tables and texts. The association between single explanatory variable and dependent variable was examined through bivariate analysis, by computing odds ratio at 95% confidence level. Multivariable logistic regression was doing to identify the risk factors associated with type two diabetes mellitus, and to control confounding variables. Crude and Adjusted odds ratio with 95% Confidence Interval was calculating. For all statistical significance tests between each independent and dependent variables, significant at P < 0.05 was considered reliable for the analysis of this study. 4.10. Quality Assurance Intensive two days training was provided for data collectors and supervisors by the principal investigator to have better awareness about the data collection techniques, ethical considerations and quality of the data. Before the actual data collection, pre-test was conducting on 5% of the same source population in Shire Sehul hospital. Based on the findings of the pre test modifications and developments of the tool had made. Data collectors were informed to check the completeness of each questionnaire whether each and every question 8 have been completely answered, and also supervisors were rechecked the completeness of the questionnaire immediately after submission. 4.11. Ethical Consideration Ethical approval was secured from institutional review board of Mekele University College of health science. Permission was received from Tigray regional health bureau and central zone administrative office using formal letter. Informed verbal consent was obtained from each hospital managers and informed written consent was also obtained from study participants to confirm their willingness for participation after having explained the objectives of the study, control groups were asked their willingness for screening of Diabetes Mellitus and blood was taken by trained health professionals. Only those who were interested to participate were involved in the study and those who were not willing to participate had given the right to do so. Respondents were notified that they have the right to refuse or terminate at any point of the interview. The information provided by each respondent has been kept confidential. The questionnaire was prepared in such a way that the respondents name was not being included in questionnaire to keep confidentiality. In addition, Privacy of the respondents was maintained, and cultural norms were respected properly. Participants were assured that they will not face anything for their participation in the study. Other responsible authorities were also informed to contribute their support and commitment to the study. 5. Results 5.1. Socio- demographic Characteristics of Study participants In this study, out of the total 363 study participants, 358 respondents participated in the study with a response rate of 98.6%. Among the respondents 71 (97.3%) cases were and 287 (98.9%) were controls. Of the respondents, more than half 38(53.5%) of cases and 166(57.8%) of controls were males. The mean (+SD) age of respondents was 41.18 (+ 13.155) years for cases and 36.76(+12.726) years for controls in the study; and 19(26.8%) cases and 61(21.3%) of controls were in the age group of 40-49 years. Most of the study subjects, 45(63.4%) cases and 173(60. 3%) controls were married. Majority of the respondents, 70(98.6%) cases and 278(96.9%) controls were Tigray in Ethnicity; and 58(81.8%) cases and 224 (78%) controls of the participants were

International Journal of Pharmaceutical and Biological Sciences Fundamentals, Vol. 07, Issue 01, October 2014 WWW..COM ISSN: 2278-3997 orthodox in religion. Among the respondents, 48(67.6%) cases and 147(51.2%) controls were urban residents and 30(42.3%) of cases and 118(41.1%) controls were illiterate. Depending occupational status of respondents, 9(12.7 %) cases and 11(3.8%) controls were unemployed; 18(25.4%) cases and 48(15.3%) controls were Civil servants. The median monthly family income was 2,000.00 birr for cases and 1,200.00 birr for controls, and 21(29.6%) of cases and 136(47. 6%) of controls were in the family income category of <1000.00 birr per month. (Table 1) Table 1: Socio demographic characteristics of the respondents in central zone of Tigray, North Ethiopia, 2014 Variables Cases controls Sex: Age group: Male Marital status: Ethnicity: Religion: Residence Area: N (%) N (%) 38(53.5) 166(57.8) Female 33(46.5) 121(42.2) 20-29 16(22.5) 105(36.6) 30-39 15(21.1) 65(22.6) 40-49 19(26.8) 61(21.3) 50-59 13(18.3) 36(12.5) 60+ 8(11.3) 20(7) Single 13(18.5) 84(29.3) Married 45(63.4) 173(60.3) Divorced 7(9.9) 12(4.2) Widowed 6(8.5) 18(6.3) Tigray 70(98.6) 278(96.9) others 1(1.4) 9(3.1) Orthodox 58(81.7) 224(78) Muslim 10(14.1) 50(17.4) Others 3(4.2) 13(4.5) Rural 23(32.4) 140(48.8) Urban 48(67.6) 147(51.2) Educational status: Illiterate 30(42.3) 118(41.1) 1-8 grade (Elementary) 16(22.5) 45(15.7) 9-12 grade (Secondary) 10(14.1) 67(23.3) College and above 15(21.1) 57(19.9) 9

International Journal of Pharmaceutical and Biological Sciences Fundamentals, Vol. 07, Issue 01, October 2014 WWW..COM ISSN: 2278-3997 Continue Table 1: Socio demographic characteristics of the respondents in central zone of Tigray, North Ethiopia, 2014 Variables Cases controls N (%) N (%) Occupation: Student 3(4.2) 34(11.8) Merchant 8(11.3) 44(15.3) Civil servant 18(25.4) 48(15.3) Nongovernment employee 7(9.9) 15(5.2) House wife 7(9.9) 33(11.5) Daily laborer 7(9.9) 30(10.5) Farmer 12(16.9) 72(25.1) Unemployed 9(12.7) 11(3.8) Family income: <1000 21(29.6) 136(47.4) 1001-2000 17(23.9) 119(41.5) 2001-3000 13(18.3) 21(7.3) >3000 20(28.2) 11(3.8) 5.2. Behavioral related Characteristics of Study participants Of the total respondents, 10(14.1%) cases and 18(6.3%) controls were ever smoking any tobacco products in their life time. Of them, 5(7.05%) of the cases and 10(3.5%) of controls were currently smoking any tobacco products. Among the study participants, 21(29.6%) of cases and 78(27.2%) controls reported as ever consuming alcohol. Of them 19(26.8 %) of cases and 67(23.3%) controls were drinking any alcohol currently. From all the respondents, 30(42.3%) cases and 225(78.4%) controls were reporting as they eat fruits and vegetables regardless of the number of days eating and number of servings they eat per day. Similarly, 6(8.5%) respondents of cases and 11(3.8%) controls were reported as they eat based on the recommended daily servings of fruits and vegetables. More than half of the respondents were also using mostly margarine oil for their meal preparations. Regarding physical activity, Assessment of self-reported physical activity showed that 47.9 % of cases and 8.4% of controls were regarded as inactive in physical activity (Table 2). 10

International Journal of Pharmaceutical and Biological Sciences Fundamentals, Vol. 07, Issue 01, October 2014 WWW..COM ISSN: 2278-3997 Table 2: Distribution of various behavioral factors of the respondents in central zone of Tigray, North Ethiopia, 2014 Variables Cases Controls N (%) N (%) Ever smoke any tobacco products: Yes 10(14.1) 18(6.3) No 61(85.9) 269(93.7) Smoking habit: Current smokers 5(7.05) 10(3.5) Previous smokers 5(7.05) 8(2.8) Non smokers 61(85.9) 269(93.7) Daily smoking habit <5 cigarettes 3(4.2) 7(2.4) > 5cigarettes 2(2.8) 3(1) Ever consumed alcohol Yes 21(29.6) 78(27.2) No 50(70.4) 209(72.8) Currently drinking alcohol: Yes 19(26.8) 67(23.3) No 2(2.8) 11(3.8) Frequency of alcohol drinking Frequent drinkers 7(9.9) 23(8) Social drinkers 12(16.9) 44(15.3) Non drinkers 52(73.2) 220(76.7) Alcohol drinking status heavy drinkers 2(2.8) 6(2.1) Moderate drinkers 3(4.2) 9(3.1) Less drinkers 14(19.7) 52(18.1) 11

International Journal of Pharmaceutical and Biological Sciences Fundamentals, Vol. 07, Issue 01, October 2014 WWW..COM ISSN: 2278-3997 Variables Cases Control N (%) N (%) Eating fruits and vegetables: Yes 30(42.3) 225(78.4) No 41(57.7) 62(21.6) No of days eating fruits/ Vegetables per week: >3 days per week 16(22.5) 121(42.2) <3 days per week 55(77.5) 166 (57.8) No of servings of fruits/ vegetables per day: >3 servings per day 6(8.5) 11(3.8) <3 servings per day 65(91.5) 276(96.2) Type of oil or fat uses for meal preparation: Vegetable oil 23(32.4) 184(64.1) Butter 5 (7) 3(1) Margarine 35(49.3) 72(25.1) Others 8(11.3) 28(9.8) Physical activity: Active 29(40.8) 240(83.6) moderately active 8(11.3) 23(8) Inactive 34(47.9) 24(8.4) 5.3. Medical related Characteristics of Study participants Of the total respondents, 26(36.6%) of the cases and 71(24.7%) of controls were ever measured their blood pressure by health professionals. regarding family history of diabetes, 19(26.8%) of cases and 39(13.6%) of controls reported as having family history of diabetes mellitus. Among the respondents, 34(47.9 %) of cases and 13(4.5%) of controls were Overweight/ Obese in their body mass index (BMI). From the study participants 28(39.4%) of cases and 20(7%) controls were hypertensive in this study. The mean (+ SD) systolic blood pressure was 124.9(+ 16.045) mmhg for cases and 110.19 (+ 13.88) mmhg for controls; and 22(31%) cases and 10(3.5%) cases was found with systolic hypertension (Table 3). 12

International Journal of Pharmaceutical and Biological Sciences Fundamentals, Vol. 07, Issue 01, October 2014 WWW..COM ISSN: 2278-3997 Table 3: Distribution of respondents related to medical factors in central zone of Tigray, North Ethiopia, 2014 Variables Cases Control N (%) N (%) Ever measured Blood pressure: Yes 26(36.6) 71(24.7) No 45(63.4) 216(75.3) Family history of Diabetes: Yes 19(26.8) 39(13.6) No 52(73.2) 248(86.4) History of DM in family: Parents 10(52.6) 16(5.6) Sister (s) 4(21.1) 10(3.5) Brother(s) 5(26.3) 13(4.5) Body mass index (BMI): Overweight/ Obesity 34(47.9) 13(4.5) Under weight 3 (4.2) 38 (13.2) Normal 34 (47.9) 236 (82.3) Hypertension: Yes 28(39.4) 20(7.0) No 43(60.6) 267(93.0) Systolic hypertension: Yes 22(31) 10(3.5) No 49(69) 277(96.5) Diastolic hypertension: Yes 24(33.8) 13(4.5) No 47(66.2) 274(95.5) 5.4. Risk factors associated with type 2 Diabetes mellitus In this study the results of bivariate logistic regression analysis showed that Residence, Occupational status, Family Income, Smoking any tobacco products, Dietary habit, Physical activity, family history of Diabetes, BMI, and Hypertension were found to be significantly associated with type 2 diabetes mellitus. From the variables associated with type 2 diabetes mellitus in the results of Bivariate 13 logistic regression; Smoking any tobacco products, Dietary habit, Physical activity, Body mass Index, and Hypertension were statistically significant with type 2 Diabetes mellitus in the multivariable logistic regression analysis. The other variables: Residence, occupation, Family Income, Number of days eating fruits and vegetables; and Family history of diabetes which were statistically significant in the bivariate logistic regression were failed to be statistically significant in the multivariable logistic regression. Smoking any tobacco products was significant risk

International Journal of Pharmaceutical and Biological Sciences Fundamentals, Vol. 07, Issue 01, October 2014 WWW..COM ISSN: 2278-3997 factor for developing type 2 diabetes mellitus in this study. Ever smoking individuals were 4.254 times more likely to develop type 2 Diabetes mellitus than those who never smoke any tobacco products (AOR = 4.254, 95% CI = [1.159, 15.621]). Individuals who do not eat fruits and vegetables as a dietary habit were 7.044 times more likely to develop type 2 diabetes mellitus than individuals who eat fruits and vegetables (AOR = 7.044, 95% CI = [2.475,20.049]). Physical inactivity also appeared to be an important risk factor associated with type 2 diabetes mellitus. Physically inactive individuals were 8.942 times more likely to develop type 2 Diabetes mellitus than physically active individuals (AOR = 8.942, 95% CI = [2.866, 0.27.905]).Physically moderately active individuals were also 4.844 times more likely to develop type 2 Diabetes mellitus than physically active individuals (AOR = 4.844, 95% CI = [1.336, 17.559]). Body mass index was also other risk factor in developing type 2 diabetes mellitus. Individuals who have Overweight/ Obesity in their body mass index were 9.608 times more likely to develop type 2 diabetes Mellitus than individuals with normal body mass index(aor = 9.608, 95% CI = [3.561, 25.924]). Individuals who have hypertension were about 5.938 times more likely to develop type 2 diabetes mellitus than those who had normal blood pressure (AOR = 5.938, 95% CI = [2.134, 16.522]) (Table 4). 14

International Journal of Pharmaceutical and Biological Sciences Fundamentals, Vol. 07, Issue 01, October 2014 WWW..COM ISSN: 2278-3997 Table 4:Risk factors associated with type 2 Diabetes mellitus in central zone of Tigray, 2014: Multivariable analysis Variables Type 2 DM COR( 95% CI) AOR( 95% CI) Cases N Controls N (%) (%) Residence area: Urban 48 (67.6) 147 (51.2) 1.98(1.149,3.439) Rural 23 (32.4) 140 (48.8) 1 Occupation: Student 3 (4.2) 34 (11.8) 0.529 (0.140,2.00) Merchant 8 (11.3) 44 (15.3) 1.091 (0.414,2.878) Civil servant 18 (25.4) 48 (16.7) 2.250 (0.994,5.092) NG employee 7 (9.9) 15 (5.2) 2.80 (0.946,8.291) House wife 7 (9.9) 33 (11.5) 1.273(0.459,3.527) Unemployed 9 (12.7) 11 (3.8) 4.909 (1.680,14.343) Daily laborer 7 (9.9) 30 (10.5) 1.400 (0.506,3.901) Farmer 12 (16.9) 72 (25.1) 1.000 Family Income >3000 20 (28.2) 11 (3.8) 11.775(4.946,28.034) 2001-3000 13 (18.3) 21 (7.3) 4.009 (1.747,9.198) 1001-2000 17 (23.9) 119 (41.5) 0.925(0.466,1.836) <1000 21 (29.6) 136 (47.4) 1 Ever smoking any tobacco products: Yes 10 (14.1) 18 (6.3) 2.450(1.077,5.571) 4.254(1.159,15.621) No 61 (85.9) 269 (93.7) 1 1 15

International Journal of Pharmaceutical and Biological Sciences Fundamentals, Vol. 07, Issue 01, October 2014 WWW..COM ISSN: 2278-3997 Continue Table 4:Risk factors associated with type 2 Diabetes mellitus in central zone of Tigray, 2014: Multivariable analysis Variables Eating fruit / vegetables: Type 2 DM COR( 95% CI) AOR( 95% CI) Cases N Controls N (%) (%) Yes 30 (42.3) 225 (78.4) 1 1 No 41 (57.7) 62 (21.6) 4.960(2.866,8.583) 7.044(2.475,20.049) No of days eating fruits/ vegetables per week: <3 days per week 55 (22.5) 166 (42.2) 0.399(0.218,730) > 3 days per week 16 (77.5) 121 (57.8) 1 Physical activity: Inactive 34 (47.9) 24 (8.4) 11.724(6.125,22.441) 8.942(2.866,27.905) Moderately active 8 (11.8) 23 (8.0) 2.879(1.180,7.024) 4.844(1.336,17.559) Active 29 (40.8) 240 (83.6) 1 1 Family history of Diabetes mellitus: Yes 19 (26.8) 39 (13.6) 2.323(1.244,4.339) No 52 (73.2) 248 (86.4) 1 Body Mass Index (BMI): Obesity/overweight 34(47.9) 13(4.5) 18.154(8.72,37.796) 9.608(3.561,25.924) Underweight 3 (4.2) 38 (13.2) 0.548(0.160,1.873) 1.237(0.301,5.093) Normal 34 (47.9) 236 (82.3) 1 1 Hypertension: Yes 28 (39.4) 20 (7) 8.693(4.502,16.786) 5.938(2.134,16.522) No 43 (60.6) 267 (93) 1 1 6. Discussion The study subjects included in to cases and controls were assessed their risk factors associated with type 2 Diabetes mellitus in central zone of tigray, North Ethiopia. Here a group of subjects with a disease of interest and control group of individuals without the 16 diseases were investigated by comparing the proportion of individuals with the exposure of interest in the two groups. In this study the cases were with type 2 diabetes mellitus that have follow ups among Governmental hospitals in the study area. Whereas controls were visitors and patient care takers who were free of diabetes mellitus in the study period

International Journal of Pharmaceutical and Biological Sciences Fundamentals, Vol. 07, Issue 01, October 2014 WWW..COM ISSN: 2278-3997 and area. Type 2 diabetes mellitus is one of the most important emerging public health problems in developing countries like Ethiopia. This study assessed the risk factors associated with type 2 diabetes mellitus in socio-demographic, behavioral and medical characteristics of cases and controls, and revealed that Smoking any tobacco, Dietary habit, physical activity, BMI, and hypertension were significantly associated with type 2 diabetes mellitus. Smoking any tobacco products was observed in 14.1% of cases and 6.3% controls in this study, and it was a significant risk factor with 4.254 times more likely to develop type 2 diabetes mellitus in comparing with those who never smoke any tobacco products. This study is consistent with the study conducted in different countries like England (19), Asia (20), Denmark (21), and India (35), which showed that smoking any tobacco products, appeared as a significant risk factor in developing type 2 diabetes mellitus. Smoking increases sugar in blood cells by distorting beta-cells and contributes to insulin resistance. Since smoking is a modifiable risk factor, this study helps to strengthen activities aimed to limit or stop smoking in preventing type 2 diabetes mellitus. Dietary habit was statistically significant risk factor with type 2 diabetes mellitus in this study; 57.7% of cases and 21.6% of controls were reporting not eating fruits and vegetables in their diet. Individuals who do not consume fruits and vegetables were about 7.044 times more likely to develop type 2 diabetes mellitus than who were eating fruits and vegetables in their diet consumption. This study was supported by other studies in Asia (20), Northern Nigeria (22), and Sub-Saharan Africa (23), which showed that the increase in type 2 diabetes mellitus was due to low intake or not consuming fruits and vegetables, and significantly associated with developing Type 2 diabetes mellitus. This is due to the fact most fruits and vegetables are high in fiber and nutrient dense but low in calories and this is an important dietary habit to prevent Type 2 diabetes mellitus. Regarding physical activity, 47.9% cases and 8.4% controls were physically inactive in this study. Physical inactivity was associated with type 2 diabetes mellitus; this finding showed that physically inactive individuals were about 9 times higher than physically active individuals to develop type 2 diabetes mellitus. The difference between cases and controls in physical activity could be due to the difference in occupational status as well as their physical fitness but occupational status was not statistically significant in this study. The finding was consistent with previous studies of Nigeria (22, 24), Denmark (19), Asia (20) and Sub-Saharan Africa (23). Physical activity contribute to improve insulin 17 sensitivity, decrease blood glucose and blood pressure level, weight loss, reduce cholesterol, increase muscle tone, improve circulation, stress relief and well being feelings (26). In addition, physical activity or exercise helps to prevent overweight/ obesity in body mass index. The result of this study shows that physical activity has the protective effect in developing type 2 diabetes mellitus. Body mass index was also significantly associated with type 2 diabetes mellitus in this study. Overweight/obese in body mass index individuals were about nine times more likely to develop the disease of interest than normal body mass index individuals. The difference could be due to the difference in dietary habits, physical inactivity and also age. Obesity/ Overweight increases the risk of developing type 2 diabetes mellitus (37), and these results from an imbalance between excessive calorie consumption and low physical activity. The link between obesity and type 2 Diabetes development was through insulin resistance caused by fatty tissue followed by progressive beta cells failure because forced to increase amount of insulin blood glucose then accumulates and induced apoptosis of beta cells, insulin deficiency will occur and type 2 diabetes comes as a diagnosis (38). This study is consistent with other studies in Ethiopia (Bishoftu), overweight was a risk factor with type 2 diabetes mellitus (30), Studies from other countries also supported this study that BMI was significantly associated with type 2 diabetes mellitus (19, 20, 22, 23, 24, and 34). Hypertension was observed in 39.4% cases and 7% controls. Having hypertension was about 6 times more likely to develop type 2 diabetes mellitus in this study. The difference could be due to their behavioral life styles like physical inactivity, low intake of fruits and vegetables; and age. The finding goes in parallel with other studies in India (35), Bishoftu in Ethiopia (30), Nigeria (22), Denmark (19), Asia (20) and Sub- Saharan Africa (23). This study revealed a significant association of hypertension with type 2 diabetes mellitus. 6.1. Strengths of the Study The design of the study (case control) may be relatively better than other study designs which needs small sample size and helps to identify multiple exposure status in relation to the disease of interest. This study also used internationally adopted instrument and trained health professional data collectors for the quality of the data, and helps to provide information on the risk factors of type 2 diabetes mellitus, since information regarding the risk factors in general is scarce.