A cross sectional study was conducted at Madda Walabu University Goba referral hospital (MWU GRH), Bale zone, South East Ethiopia which is 445 km far away from Addis Ababa from April 15 - May 30, 2019 on adult diabetic patients. All type 1 and type 2 diabetic patients of age 18 years and above visiting MWU Goba referral hospital were included. But diabetic patients those who were critically ill (in coma), diabetic patients with known pancreatic disease before DM onset and diabetic patients with salivary gland inflammation was excluded by card review and after physical inspection done by physician.
The sample size was calculated by using a single population proportion formula by considering the following assumptions. Since the prevalence of pancreatic exocrine insufficiency among diabetics in Ethiopia was not available P = 50% and margin of error d = 0.05 with 95% confidence interval was used.
Level of significance α = 0.05; 95% CI: Zα/2=1.96
Expected non-response rate =10%
Non-response rate = 10%*267 ~27
Nf = 267 + 27 = 294 Therefore, the total sample size of this study was 294.
The study unit was selected from the study population by systematic random sampling. There were 869 diabetic patients registered for attending MWU GRH for diabetic follow up and the sample size is 294. Therefore, the sampling interval was:
K = 869/294 = 3
The starting point was randomly selected among 1, 2 and 3; then those who registered every three intervals was participated in the study.
Interviewer-administered semi-structured questionnaire was adapted from different articles and guidelines those related to this study. Then the adapted tool was translated to the local languages Afan Oromo and Amharic languages and then back to English to ensure its consistency and accuracy. The questionnaire was contained socio-economic and demographic characteristic of the respondent, his/her health condition, life style and laboratory result registration format. The data collectors were trained on the objective of the study, data collection tool, approach to the interviewees, details of interviewing techniques, respect and maintaining privacy and confidentiality of the respondents before going to the data collection.
Data were collected by trained nurses by using a semi structured questionnaire through face to face interview and the type of DM and the type of medication they used were obtained by reviewing their card. The biological sample was collected and analyzed by the laboratory technologists according to standard operating procedure (SOP). Accordingly, 5ml of blood were collected from each study participants, then it was allowed to clot for 30 minute. Then, the cells were separated from serum by centrifuging the blood at 3000 rpm for 5 minute. The serum sample was analyzed by spectrophotometer using different reagents for each parameter. From each study participants 10ml of urine was collected and analyzed after centrifugation at 3000 rpm for 5 minute. The qualitative tests were done by immersing dry reagent dipstick in to urine and urine creatinine concentration and urine amylase activity was done by spectrophotometer.
Pancreatic exocrine insufficiency was the dependent variable and age, sex, residence, monthly income, occupation, and educational level were the socio economic independent variables. In addition to this blood pressure, type of DM, type of medication, age of onset, duration of the disease, smoking habit, alcohol use and BMI were included as life style and health condition independent variables. Serum analytes and calculated parameters such as FBS level, GFR, serum creatinine, serum urea and BUN were also included.
After checking the completeness of the data manually, the collected raw data were entered, cleaned and checked by Epi data version 4.0.2 and then it was exported to SPSS version 25 statistical packages for analysis. Descriptive analysis of different variables was done and variables with p-value <0.25 in binary logistic regression were used as a candidate for multiple logistic regression. Finally, the variables in multiple logistic regression that have significant association were identified by calculating odds ratio, with 95% confidence interval and p- value less than 0.05 was used to declare statistical significance.
To avoid the possibility of sampling bias, a minimum sample size sufficient to study the objectives of the study was determined. Pretest was done on 5% of the sample size (21 individuals) at Bale Robe Hospital. The collected data were checked for the completeness, clarity and consistency on the daily basis. Supervisor and principal investigator were closely follow both biological sample and information data collection process. After data collection, data were edited, coded, cleaned and some inconsistencies were checked in order to assess the quality of data.
Pancreatic exocrine insufficiency: is defined as inability of pancreas to secrete the digestive enzymes that result in maldigestion of macromolecules. It is manifested by either serum amylase activity <28 U/l (normal range 28-100 U/l) or serum lipase activity <13 U/l (normal range 13-60 U/l) (14).
Five ml of venous blood was collected from each study participants in to tube with clot activator and the cells were separated from the serum within 30 minutes in order to prevent glycolysis that could be taken place by blood cells. Hemolysed sample was discarded because, it disturbs the absorbance of the solution during spectrophotometric reading. If the reading was above the measuring capacity of the spectrophotometer, the serum was diluted and the result was multiplied by dilution factor prior to reporting/registration (15).
Ethical clearance was obtained from institutional review board of Jimma University Institute of Health. Formal letter was obtained from Jimma University Institute of health to MWU GRH and the permission to conduct the study was obtained from chief executive of MWU GRH. Then both written and oral consent was obtained from each study participant. The name of the study participants was omitted from the questionnaire and the registration number/code was used to ensure the confidentiality. All abnormal laboratory result was linked to internal medicine department in the hospital for appropriate management of the study participants.