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
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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COMPLETED
4011 participants
OBSERVATIONAL
2015-02-28
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Gestational DM or secondary-induced diabetes
* Diabetic ketoacidosis or hyperosmolar coma
* Alcohol abuse or acute alcohol intoxication
18 Years
ALL
No
Sponsors
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Medirex Group Academy
UNKNOWN
Slovak Technical University
UNKNOWN
Comenius University
OTHER
Novartis Slovakia, s.r.o.
INDUSTRY
Responsible Party
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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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