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

Diabetes Mellitus Clinical Trial

— DIARET SK  

Official title:

DIARET SK - 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02232503
• Other study ID #: CRFB002DSK01
• Status: Completed
• Phase: N/A
• First received: September 3, 2014
• Last updated: September 21, 2016
• Start date: February 2015
• Est. completion date: November 2015

Study information

• Verified date: September 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovakia:Ethics Comitee of Bratislava Region
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4011
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Macular Edema
• Diabetic Retinopathy
• Macular Edema
• Retinal Diseases

Intervention

Genetic:
• Studied cohort
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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Novartis Slovakia, s.r.o.	Faculty of Natural Sciences of Comenius University, Medirex Group Academy, Slovak Technical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Epidemiological characteristics of patients with Diabetes Mellitus and with Diabetic Retinopathy in terms of demographic structure, treatment and control of DM and the presence of other microvascular and ophthalmologic complications	The patient characteristics will be described as by standard methods of descriptive statistics - N, %, mean, media, min, max, SD and where necessary accompanied by the histogram or contingence table.	participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria	No
Other	Evaluate the impact of diabetic retinopathy and diabetes mellitus on the Quality Of Life as measured by NEI-VFQ25 questionnaires	The impact of DR and DME on the quality of life in case of patients with DM will be realized using ANCOVA method where QoL will be evaluated as the continuous variable. The multivariate analysis will include all relevant patient characteristics including visual acuity, age and gender of the patient. These characteristics will serve as covariates to correct for the difference in characteristics of patient with/without DR.	participants examined each working day within selected working hours during a 6 months period in selected ophthalmology centers according to protocol criteria	No
Other	Investigate DNA polymorphisms and phenotypic features correlating with the development of DR in patients with extreme phenotypes.	Genetic analysis is primarily exploratory in nature, does not test the hypothesis previously postulated and formal calculation of sample size can not be determined. In combination with accurately determined ocular and diabetic history is sample size above standard within typical publications of the topic.	DNA analysis during 7 months post study screening period	No
Other	The analysis of mitochondrial DNA haplotypes in pre-defined patient groups	Basic statistical analysis will include binary logistic regression (OR, 95% CI) and Fisher test. This method evaluates the statistical significance for the increase or decrease in the risk of DR for easy single nucleotide polymorphisms (SNPs) in in mitochondrial DNA (mtDNA), their combinations - DNA haplotypes, haplogroups and their clusters and thus identifies possible genetic factors involved in the study disease.	DNA analysis during 7 months post study screening period	No
Other	The identification of patients with monogenic DM by biomarkers (hsCRP)	Calculation of prevalence HNF1A-MODY in a wide Slovak population with diabetes using biomarker hsCRP.; Comparison of the severity of retinopathy in mutation carriers of HNF1A-MODY and type 2 diabetes / type 1 diabetes patients in the specified data set.	DNA analysis during 7 months post study screening period	No
Other	Identification of patients with extreme phenotypes and family history of DM with eye complications		DNA analysis during 7 months post study screening period	No
Primary	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.	participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria	No
Secondary	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.	participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria	No
Secondary	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	participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria	No
Secondary	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.	participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria	No