Clinical trial NCT02232503: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Diabetic Macular Edema
Diabetes Mellitus
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Medirex Group Academy
name: Slovak Technical University
name: Comenius University
First posted: 2014-09-05
Enrollment: 4011
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Total expected number of patients included in this survey is 5000. With the objective to guarantee non-biased patient selection sample, each screening day the pre-specified sequence of patients (5th, 10th, 15th...) will selected. If the pre-selected patient does not come for visit or does not fulfill the inclusion criteria or does not want to sign the informed consent the next patient is asked to participate in the research. We plan to enroll 4500 patients using this non-biased method.

The weakness of the non-biased random selection is that the less frequent groups of patients will not have enough subjects for the proper statistical analysis. To correct for this effect pool of 500 patients is reserved for special subgroups. Pre-defined subgroups are:

1. patients with DM duration more 20 years
2. patients with DM duration less than 5 years already with DR in history All patients from these subgroups will be asked to participate in this project regardless of the pre-specified order.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The prevalence of diabetic retinopathy as the proportion of patients with DR (any stage) in a given subgroup according to DM duration
timeFrame: participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria
Secondary outcomes:
measure: Evaluate the prevalence and individual stages of Diabetic Retinopathy in patients with type 1 and type 2 DM verified based on complex ophthalmologic measurements
timeFrame: participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria
measure: 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
timeFrame: participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria
measure: Evaluate the impact of risk factors on the prevalence of Diabetic Retinopathy and Diabetic Macular Edema
timeFrame: participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria
Other outcomes:
measure: 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
timeFrame: participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria
measure: Evaluate the impact of diabetic retinopathy and diabetes mellitus on the Quality Of Life as measured by NEI-VFQ25 questionnaires
timeFrame: participants examined each working day within selected working hours during a 6 months period in selected ophthalmology centers according to protocol criteria
measure: Investigate DNA polymorphisms and phenotypic features correlating with the development of DR in patients with extreme phenotypes.
timeFrame: DNA analysis during 7 months post study screening period
measure: The analysis of mitochondrial DNA haplotypes in pre-defined patient groups
timeFrame: DNA analysis during 7 months post study screening period
measure: The identification of patients with monogenic DM by biomarkers (hsCRP)
timeFrame: DNA analysis during 7 months post study screening period
measure: Identification of patients with extreme phenotypes and family history of DM with eye complications
timeFrame: DNA analysis during 7 months post study screening period
Locations:
Study officials:
affiliation: Novartis Slovakia
name: Dagmar Buckova, M.D.
role: STUDY_DIRECTOR
affiliation: Novartis Slovakia, s.r.o.
name: Peter Carnogursky, MSc.
role: STUDY_DIRECTOR
affiliation: Novartis Slovakia, s.r.o.
name: Svetlana Sefcikova, MD
role: STUDY_DIRECTOR
affiliation: Novartis Slovakia, s.r.o.
name: Pavol Tison, MD
role: STUDY_DIRECTOR
affiliation: Novartis Slovakia, s.r.o.
name: Iveta Tvrda, MD
role: STUDY_DIRECTOR
affiliation: Novartis Slovakia, s.r.o.
name: Daniela Gasperikova, MSc., PhD.
role: STUDY_DIRECTOR
affiliation: Medirex Group Academy
name: Ivana Hojsikova, RNDr.
role: STUDY_DIRECTOR
affiliation: Comenius University
name: Ludevit Kadasi, RNDr., DrSc.
role: STUDY_DIRECTOR
affiliation: Novartis Slovakia, s.r.o.
name: Iwar Klimes, Prof., MD, DrSc.
role: STUDY_DIRECTOR
affiliation: University Hospital Bratislava
name: Peter Jackuliak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Bratislava
name: Vladimir Krasnik, MD PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute for Endocrinology and Diabetology
name: Emil Martinka, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jesenius University Martin
name: Marian Mokan, Prof. MD DrSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Diabetology Dispensary Bratislava
name: Zuzana Nemethyova, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: F.D. Roosevelt Hospital Banska Bystrica
name: Marta Ondrejkova, MD PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Bratislava
name: Jana Stefanickova, MD
role: PRINCIPAL_INVESTIGATOR
References: