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

Completed

• Conditions: Diabetic Macular Edema; Diabetic Retinopathy; Diabetes Mellitus

• Registration Number: NCT02232503
• Lead Sponsor: Novartis Slovakia, s.r.o.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-03
• Study First Submitted QC: 2014-09-03
• Study First Posted: 2014-09-05
• Study Start: 2015-02
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-21
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4011

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The prevalence of diabetic retinopathy as the proportion of patients with DR (any stage) in a given subgroup according to DM duration	participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria	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.

Secondary Outcome Measures

Name	Time	Method
Evaluate the prevalence and individual stages of Diabetic Retinopathy in patients with type 1 and type 2 DM verified based on complex ophthalmologic measurements	participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria	The calculation of prevalence for each stage of DR will be analyzed using the same methods as for the total DR prevalence.
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	participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria	The calculation of prevalence for each stage of DME will be analyzed using the same methods as for the total DR prevalence
Evaluate the impact of risk factors on the prevalence of Diabetic Retinopathy and Diabetic Macular Edema	participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria	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.