Prevalence of DIAbetic RETinopathy and Impact of Genetic Factors in the Development of Diabetic Retinopathy of Patients With Type 1 and 2 Diabetes Mellitus in SlovaKia

Novartis Slovakia, s.r.o.4,011 enrolled

Overview

The aim of the study is to find out prevalence and individual stages of Diabetic Retinopathy in patients with type 1 and type 2 DM verified based on complex ophthalmologic measurements in Slovak Republic. The outcome of the project will be epidemiology survey, prevalence of diabetic retinopathy (DR) and diabetic macular edema (DME) in relation to type and duration of diabetes mellitus and risk factors. Project will also identify genetic factors linked with the diseases.

Study Type

OBSERVATIONAL

Enrollment

4,011

Conditions

Diabetic Retinopathy Diabetic Macular Edema Diabetes Mellitus

Interventions

Studied cohortGENETIC

For the purpose of DNA isolation prior to genetic analysis of patients two samples of peripheral blood will be taken; first in the volume of 3.5 ml and second in the volume of 9 ml from each patient included into the study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * Signed informed consent for epidemiological research * Signed informed consent for genetic research * Patients with DM - type I and II regardless of the DM duration * All DM patients must be included regardless of presence of eye complications in patient´s anamnesis or during the examination by the diabetologist Subgroups analysis * Patients with DM - type I and II and DM duration ≥ 20 years * Patients with DM - type I and II and DM duration \< 5 years and DR in history Exclusion Criteria: * Age at the time of inclusion into the \<18 years * Gestational DM or secondary-induced diabetes * Diabetic ketoacidosis or hyperosmolar coma * Alcohol abuse or acute alcohol intoxication

Outcomes

Primary Outcomes

The prevalence of diabetic retinopathy as the proportion of patients with DR (any stage) in a given subgroup according to DM duration

The results will be accompanied by Wald 95% confidence intervals. The combined prevalence results from more subgroups will be evaluated using weighted average using the best available epidemiology data.

Time frame: participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria

Secondary Outcomes

Evaluate the prevalence and individual stages of Diabetic Retinopathy in patients with type 1 and type 2 DM verified based on complex ophthalmologic measurements

The calculation of prevalence for each stage of DR will be analyzed using the same methods as for the total DR prevalence.

Time frame: participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria

Evaluate the prevalence and individual stages of Diabetic Macular Edema (DME) in patients with type 1 and type 2 DM verified based on complex ophthalmologic measurements

The calculation of prevalence for each stage of DME will be analyzed using the same methods as for the total DR prevalence

Time frame: participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria

Evaluate the impact of risk factors on the prevalence of Diabetic Retinopathy and Diabetic Macular Edema

The analysis will be realized using multivariate logistics regression. The output of the analysis will be the impact statistical significance of the individual risk factors represented by odds ratio for each risk parameter accompanied with statistical significance and corresponding confidence interval. The risk factors will be at least: age, gender, ethnicity, DM duration since diagnosis, glycemic control and diabetes management based on the average HbA1c of all measurements in the last 12 months, presence of nephropathy, malignancies and BMI. Age, DM duration since diagnosis, diabetes control based on the average HbA1c of all measurements in the last 12 months and BMI will be assessed as continuous covariates whereas gender, nationality, presence of nephropathy and malignancies will be considered as categorical variables.

Time frame: participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria