To assess the prevalence and associated factors of microalbuminuria among type2 diabetes mellitus patients in Jigjiga town public hospitals, Somali Regional State, Eastern Ethiopia, from April 1 to July 15, 2020
Study area and Study period
Somali Regional State is one of 10 regional states of the Federal Democratic Republic of Ethiopia located in the Eastern part of Ethiopian lowlands. The region has 11 zones and more than 90 Woreda administrations. The study was conducted in Jigjiga town, capital of Somali Regional State located 635 km from Addis Ababa to the East. The town has one referral Hospital, one general hospital, 3 health centers and 20 health posts (government), 27 higher clinics, 10 medium clinics. This study was, however, be specifically conducted in Jigjiga University Sultan Sheik Hasan Referral Hospital (JJUSSHRH) and Karamara General Hospital (KGH) where 500 T2DM clients make regular visits for follow up.
4.1.2 Study period
The study was conducted from April 1 to July 15, 2020
Institutional based cross-sectional study design was used.
Inclusion and exclusion criteria
All T2DM clients willing to provide information and take part in the survey
Menstruating women, those who have urinary tract infection, Hematuria, critically ill, those who present with acute febrile illnesses (AFI), Pregnancy, Suspected/diagnosed renal or hepatic or any systemic disorders i.e., sickle cell anemia
Sample size determination
Sample size for the first objective
The sample size was calculated by using single population proportion formula considering a 95% confidence interval, 5% margin of error and prevalence of micro-albuminuria 37% .
The total sample size =358
Since, the source population was 500, which is below 10,000, population correction formula was used. The final sample size of this study was = 222
All 222 study units were consecutively selected upon arrival and included in the study
The study participants were allocated for the two hospitals in a manner that was proportional to their number of clients registered and come for follow up. JJUSHRH had a total of 350 T2DM clients while KGH had a total of 150.
To proportionate the number of study subject for each hospital, the formula = was used. Where n=number of clients registered for follow up in each hospital, nf = total sample size and N= the total number clients registered for follow up in the two hospitals.
The proportional size For JJUSHRH was as follows
The proportional size For KGH was as follows
Data collection methods and materials
A structured questionnaire was used to interview clients in order to collect data on socio -demographic and clinical variables. Anthropometric measurements such as, Weight of the client in kilograms(kg)was measured to the nearest 0.1 kg using calibrated weighing scale and Height of the client in meters (m)was measured in standing position with shoes removed using stadiometer to the nearest 0.1 cm. Body mass index of the client in (kg/m2) was also measured and then classified based on the WHO reference values as underweight if less than 18.5, Normal if 18.5-24.99, overweight 25-29.99 and obese if greater than 30kg/m2 .
Routine physical examination was done on clients by the physicians available at the chronic clinics or outpatient departments (OPDs) as the clients visited the hospitals and those found to have significant complications of systemic disorders like cardiovascular disorders and hepatic enlargement (through palpation) were excluded from the study.
Blood pressure in millimeter mercury (mmHg) in sitting position was measured using Sphygmomanometer and stethoscope from the left arm after the individual rested for about 5 minutes, in order to record the data, an average of two measurements which are 5 minutes apart were done and finally taken as the blood pressure results of the clients. Clients were classified as hypertensive if they had systolic blood pressure of > 140 mmHg and/or diastolic blood pressure of >90mmHg or known to be hypertensive on medications (antihypertensive).
Venipuncture (venesection) was performed through aseptic technique and 8 ml of blood was collected in test tube, then the blood was analyzed within the day of collection, for complete blood count (CBC). Serum creatinine, low density lipoprotein (LDL), high density lipoprotein (HDL)and blood urea nitrogen (BUN)was measured using Biosystems A25 chemistry analyzer. Glycosylated hemoglobin (HbA1c) which represents glycemic control for the last three months with the aid of EDTA containing test tubes was also analyzed using Fine care HbA1c analyzer, and the results of the test were categorized as good control if the HbA1c value was<7% and poor control if it was >7%.FBS was measured using Prodigy Auto Code which displays the readings quantitatively and the result was categorized as normal if <80-130mg/dl (only for known DM patients) and high if > 130mg/dl. All sample were analyzed with in the day of collection.
A morning spot mid-stream urine specimen of 10 ml was collected using pre-treated containers, 5ml was taken from the 10ml using a syringe to another container for urine analysis using dipstick to check the presence of proteins, glucose, red and white blood cells. Presence of the above-mentioned substances in the urine, were dealt with an appropriate treatment through the available physicians. Microalbuminuria was checked using HemoCue® 201 albumin analyzer (HemoCue®, Ängelholm, Sweden) and its microcuvettes, HemoCue® 201 albumin analyzer is a factory calibrated electronic device that employs immunoturbidimetry and quantitatively measures a slight amount of albumin in the urine that the dipsticks cannot detect.
Microalbuminuria was measured three times one month apart then microalbuminuria was considered positive if two out of three tests within 3 months read 20-199mg/L.
Since all patients having the follow ups in these two hospitals were mainly residents of Jigjiga town and its surrounding (rural kebeles), upon meeting with the clients for the first visit, personal address like telephone and possible way of communication like neighborhood and house number were asked so that it becomes easier for the data collectors to reach/visit those who do not (if any) make a visit to the hospitals in the next follow up.
The data was collected by four diploma laboratory technologists and two BSc nurses (3 for each hospital) who were under the guidance of one BSc nurse holder supervisor for each hospital.
Procedure for data collection
Before data collection, four days of training were given for both the data collectors and supervisors by a senior laboratory technologist. Before interviewing, the data collectors informed the clients about the aims/purposes, possible risks (from physical discomfort to potential inflammation of the veins) and possible benefits of the study (potential change in the treatment protocol of their chronic disorder), the right and refusal to participate in the study. The collected information was kept confidential. Participants who were willing and sign the voluntary consent form were interviewed. Data was collected through face-to-face interviews using unstructured and pretested questionnaire.
Microalbuminuria (positive, Negative)
The independent variables for this study obtained from review of different literatures and then grouped in to three domains, demographic, behavioral and life style, clinical and biochemical
Demographic variables: - Age, Sex, Marital status and educational status
Behavioral and life style variables: Smoking and physical activity
Clinical variables: -Duration of DM, Systolic blood pressure, Diastolic blood pressure, Body mass index (BMI)
Biochemical variables: -Glycosylated hemoglobin, Fasting plasma glucose, BUN, Serum creatinine, Low density lipoprotein, High density lipoprotein
Data quality control
Four days of training were provided for the data collectors and supervisors. Pre testing of questionnaire was done at two selected private clinics in the same town and calibration of instruments was made to ensure the quality of data, to assess the reliability, clarity, sequence, consistency, and the total time that it will take to finish the questionnaire before the actual data collection begins. Then after, the necessary feedbacks were incorporated in the final tool to improve its quality. Principal investigator and supervisors made spot-checking and reviewing all the completed questionnaires and specimens to ensure completeness and consistency of the information collected. Data entry was done by the principal investigator to keep accuracy of the data. The specimen was labeled with codes that match with the codes of the questionnaires to prevent mismatch of specimen and respective questionnaires.
Microalbuminuria: in this study, a urinary albumin excretion (UAE) that is between 20-199mg/Laws considered microalbuminuria as defined by Lloyd MM
Chronic clinics: clinics in the hospitals that serve clients with long term systemic disorders like diabetes mellitus and hypertension
FBS: Fasting Blood Glucose for diabetic patients was blood glucose taken after 8 hours of not eating and drinking other than water and categorized as good FBS (only for diabetic) if <80-130mg/dl and high if > 130mg/dl as recommended by WHO/IDF 2006 on hyperglycemia: report.
BMI: in this study, body Mass Index computed from weight in kg divided by height in meter squared and was considered as underweight if less than 18.5, Normal if 18.5-24.99, overweight 25-29.99 and obese if greater than 30kg/m2 according to 2016 WHO global report on diabetes .
HTN: in this study, a systolic blood pressure >140mmHg and or diastolic blood pressure >90mmHg was considered as hypertension as defined by guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults.
HbA1c: a glycosylated hemoglobin which is>7% was considered as poor control and <7% as good control in this study according to Sherwani SI.
LDL: Low density lipoprotein known as also bad cholesterol was considered as Low if the value are less than 100mg/dl, Normal if the values fall between 100-130mg/dl and High if the value exceeds 130mg/dl for Diabetics patients as defined by Suddarth B..
HDL: High density lipoprotein was considered as Low if the value was less than 35mg/dl, Normal if the value falls between (35-65mg/dl) for males and 35- 85mg/dl for females, and high if the value was higher than 65mg/dl and 85mg/dl for males and females respectively as defined by Suddarth B..
Serum creatinine: was defined as Normal if values fall between 0.7-1.5mg/dl and High if greater than 1.5mg/dl as defined by Suddarth B..
Data processing and analysis
The data was entered into statistical software Epi data version 3,1, double data entry was made and then, exported to SPSS version 20after exporting the prepared data. Descriptive statistics such as frequency distribution was computed to describe variables of the study. The data was described and presented using narrative text, tables, and chart.
Logistic regression model was used to analyze the outcome variable. It was performed in two stages; in first stage a bivariate analysis was conducted to identify a candidate’s covariates for multivariate analysis at p-value less than 0.25. In the second stage, multivariate analysis was done to see the association between the outcome variable and independent variables which were significant at bivariate stage. The direction and strength of statistical association was measured by odds ratio with 95 % CI. In this study P-value < 0.05 was considered as statistically significant.
The model adequacy and fitness were checked using Hosmer-Lemeshow goodness of fit test and all assumptions of regression analysis (model adequacy and multi collinearity of the independent variables) was also checked. Multi-collinearity was checked using variance inflated factor (VIF)/ tolerance and no multi-collinearity was found between variables.
All methods were done in accordance with the declaration of Helsinki. Ethical clearance was obtained from the Institutional Health Research Ethics Review Committee (JJU-IHRERC College of Medicine and health sciences,) of Jigjiga University. For Karamara General Hospital, a formal letter of permission and support was written to regional health bureau which is responsible for regional controlled hospitals and for Sheik Hasan Referral Hospital, Jigjiga University has written a letter to it as it’s under the control of the university. All the study participants were informed about the purpose of the study, their right to refuse was stressed and written and signed voluntary consent was obtained from all study participants prior to data collection. The respondents were assured that the information as well as specimens obtained from them will not be used for any other purpose and treated with complete confidentiality. Clients who test positive for microalbuminuria during data collection were linked back to their OPD for an appropriate treatment.
Plan for Information dissemination
The findings of this study will be submitted and presented to the School of Graduate Studies, College of Medicine and Health Sciences, of Jigjiga University. The findings of this study will also be disseminated to JJUSHRH and KGH. Furthermore, publication of this thesis will be tried as one major dissemination strategy.