EXPLORING PREVALENCE OF LONG TERM DIABETES MELLITUS VASCULAR COMPLICATIONS IN KING FAHAD GENERAL HOSPITAL

Study objective(s):- Primary objective:- To assess the cumulative and individual prevalence of microvascular and macrovascular complications among study population. Secondary objective(s) - To Map Cardiovascular Risk Factors among study population. - Correlate diabetic complication prevalence with level of diabetes control (A1C target level) Study Design &Duration:- A retrospective cross sectional study design will be used. Patients? files will be used as source of data collection in a brief case report form. To avoid duplication unique patient file number will be used as subject number preceded by investigator number. A random data source verification of 20% of the case report forms as quality control of collected data. Patients will be enrolled inn 1 month Study population:- Inclusion criteria - Male or Female patients of all age groups. - Established diagnosis of DM for more than 10 years. - Patients presented to the outpatient clinic during the last three months. Exclusion criteria - Incomplete patient?s file Expected number of patients: 375 patients attending to King Fahad General Hospital, Jeddah, Saudi Arabia. Expected number of investigators: 3 investigators. Recruitment modalities:- Selection of patients In order to allow extrapolation of the results to the broadest possible population, all consecutive patients who meet the eligibility criteria and agree to participate upon a signed consent form will be included in the study. Each physician should recruit about 125 consecutive DM patients. Endpoint(s):- Primary endpoints - Number of Micro/Macrovascular complications - Proportion of patients having micro/macro complications - Frequency of micro/macrovascular complications per patients - Proportion of individual micro/macrovascular complication among study population. Secondary endpoints - Proportion of Cardiovascular risk factors among study population and its correlation to DM vascular complications Difference in prevalence of micro/macrovascular and individual complications in patients with target A1C < 8 % or > 8% at the time of diagnosis MAIN DATA COLLECTED:- Data will be collected during a single visit in an individual case report form (CRF). No tests will be specifically done for this study. The following data will be collected: - Date of last visit, - Inclusion/exclusion criteria check, - Patient profile: - Demographic characteristics (age, gender, marital status, etc.), - Lifestyle habits (smoking status, physical activity), - Vital signs, weight, waist circumference, body mass index, blood pressure). - Family History of DM and Cardiovascular disease - Relevant history of risk factors for DM - Characteristics of diabetes: - Type of Diabetes - Duration of diabetes, - Cardiovascular Risk Factors - Microvascular Complications - Retinopathy (Date of Diagnosis, A1C level) - Nephropathy (Date of Diagnosis, A1C level) - Neuropathy (Date of Diagnosis, A1C level) - Macrovascular Complications - Ischemic heart Disease (Type, Date of Diagnosis, A1C level) - Cerebrovascular Disease (Type, Date of Diagnosis, A1C level) - Peripheral vascular Disease (Type, Date of Diagnosis, A1C level) Statistical considerations:- Sample size calculation Number of subjects: N= 375 Sample size: Distribution by country or region: Limited to one center as pilot study Statistical power and sample size justification:- According to Litwak et al. 2013;14 the prevalence of microvascular and macrovascular complications among diabetic patients in Middle East/Gulf area including Saudi Arabia was 65.8% and 28.7% respectively; accordingly: Sample size for Microvascular complications: In our study; it is hypothesized that the prevalence of microvascular complications among diabetic patients would be 60% with a precision of ? 5%. A sample size of 369 individuals will allow for a confidence level of 95% considering a 2-talied test. Sample size for Macrovascular complications: In our study; it is hypothesized that the prevalence of macrovascular complications among diabetic patients would be 25% with a precision of ? 5%. A sample size of 288 individuals will allow for a confidence level of 95% considering a 2-talied test. Statistical Analysis Plan:- Statistical analysis will be based on all patients enrolled in the registry. Descriptive analysis will be performed. Patient ?s characteristics (demographic data, risk profile, treatment, etc.) will be described for all the included patients. Quantitative data will be summarized using mean, median, standard deviation and range for continuous parameters and counts and percentages for categorical parameters. All statistical tests will be performed using two-tailed tests at a 5% level of significance. Moreover, statistical test will be performed on comparing different groups. Chi square test will be used to compare between categorical parameters. The results will be calculated at 95% CI and 5% level of significance. For parametric data; two-tailed paired t-test and repeated measures ANOVA will be used when comparing between repeated measurements while independent t-test and one way ANOVA when comparing between study groups. Non-parametric tests of significance would be used with data not normally distributed. Logistic Regression analysis would be performed to detect positive and negative predictors of microvascular and macrovascular complications. Estimated duration of the study:- Estimated enrollment duration: 1 month Estimated dates: - FPI: 1 JAN 2017 - LPI: 31 JAN 2017 - LPO: 31 JAN 2017 - Database lock date: 28 FEB 2017 Report date: 31 MAR 2017