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

NCT ID: NCT02232503

Last Updated: 2016-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4011 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-11-30

Brief Summary

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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

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Conditions

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Diabetic Retinopathy Diabetic Macular Edema Diabetes Mellitus

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Interventions

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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.

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medirex Group Academy

UNKNOWN

Sponsor Role collaborator

Slovak Technical University

UNKNOWN

Sponsor Role collaborator

Comenius University

OTHER

Sponsor Role collaborator

Novartis Slovakia, s.r.o.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dagmar Buckova, M.D.

Role: STUDY_DIRECTOR

Novartis Slovakia

Peter Carnogursky, MSc.

Role: STUDY_DIRECTOR

Novartis Slovakia, s.r.o.

Svetlana Sefcikova, MD

Role: STUDY_DIRECTOR

Novartis Slovakia, s.r.o.

Pavol Tison, MD

Role: STUDY_DIRECTOR

Novartis Slovakia, s.r.o.

Iveta Tvrda, MD

Role: STUDY_DIRECTOR

Novartis Slovakia, s.r.o.

Daniela Gasperikova, MSc., PhD.

Role: STUDY_DIRECTOR

Novartis Slovakia, s.r.o.

Ivana Hojsikova, RNDr.

Role: STUDY_DIRECTOR

Medirex Group Academy

Ludevit Kadasi, RNDr., DrSc.

Role: STUDY_DIRECTOR

Comenius University

Iwar Klimes, Prof., MD, DrSc.

Role: STUDY_DIRECTOR

Novartis Slovakia, s.r.o.

Peter Jackuliak, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bratislava

Vladimir Krasnik, MD PhD.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bratislava

Emil Martinka, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

National Institute for Endocrinology and Diabetology

Marian Mokan, Prof. MD DrSc.

Role: PRINCIPAL_INVESTIGATOR

Jesenius University Martin

Zuzana Nemethyova, MD

Role: PRINCIPAL_INVESTIGATOR

Diabetology Dispensary Bratislava

Marta Ondrejkova, MD PhD.

Role: PRINCIPAL_INVESTIGATOR

F.D. Roosevelt Hospital Banska Bystrica

Jana Stefanickova, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bratislava

Other Identifiers

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CRFB002DSK01

Identifier Type: -

Identifier Source: org_study_id

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