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

NCT02232503 | Completed

• 1 other identifier: CRFB002DSK01
• Study Type: observational
• Target: 4,011
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Retinopathy; Diabetic Macular Edema; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• 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

• 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

Other Outcomes (6)

• 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

  participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria

• Evaluate the impact of diabetic retinopathy and diabetes mellitus on the Quality Of Life as measured by NEI-VFQ25 questionnaires

  participants examined each working day within selected working hours during a 6 months period in selected ophthalmology centers according to protocol criteria

• Investigate DNA polymorphisms and phenotypic features correlating with the development of DR in patients with extreme phenotypes.

  DNA analysis during 7 months post study screening period

Interventions

Studied cohort GENETIC

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Gestational DM or secondary-induced diabetes
• Diabetic ketoacidosis or hyperosmolar coma
• Alcohol abuse or acute alcohol intoxication

Sponsors & Collaborators

• Novartis Slovakia, s.r.o.: lead
• Medirex Group Academy: collaborator
• Slovak Technical University: collaborator
• Comenius University: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

For the purpose of DNA isolation prior to genetic analysis two samples of peripheral blood will be taken. Tubes with sampled material will be stored under temperature of 2 - 8°C and in the least possible time delivered to the laboratory where DNA will be isolated. Of all the samples delivered to the laboratory, DNA will be extracted using the automated isolation method. From the second sample related to the genetic analysis also the plasma will be obtained and stored at -20°C. The DNA sample is then divided into two aliquot parts which will be stored separately for future analysis in order to decrease the risk of their impairment. DNA isolated from cells of biological material will be properly stored prior to further analysis. DNA will be archived by its freezing to -80°C, a temperature in which the characteristics are maintained for several decades.

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dagmar Buckova, M.D.

  Novartis Slovakia

  STUDY DIRECTOR

• Peter Carnogursky, MSc.

  Novartis Slovakia, s.r.o.

  STUDY DIRECTOR

• Svetlana Sefcikova, MD

  Novartis Slovakia, s.r.o.

  STUDY DIRECTOR

• Pavol Tison, MD

  Novartis Slovakia, s.r.o.

  STUDY DIRECTOR

• Iveta Tvrda, MD

  Novartis Slovakia, s.r.o.

  STUDY DIRECTOR

• Daniela Gasperikova, MSc., PhD.

  Novartis Slovakia, s.r.o.

  STUDY DIRECTOR

• Ivana Hojsikova, RNDr.

  Medirex Group Academy

  STUDY DIRECTOR

• Ludevit Kadasi, RNDr., DrSc.

  Comenius University

  STUDY DIRECTOR

• Iwar Klimes, Prof., MD, DrSc.

  Novartis Slovakia, s.r.o.

  STUDY DIRECTOR

• Peter Jackuliak, MD

  University Hospital Bratislava

  PRINCIPAL INVESTIGATOR

• Vladimir Krasnik, MD PhD.

  University Hospital Bratislava

  PRINCIPAL INVESTIGATOR

• Emil Martinka, MD, PhD.

  National Institute for Endocrinology and Diabetology

  PRINCIPAL INVESTIGATOR

• Marian Mokan, Prof. MD DrSc.

  Jesenius University Martin

  PRINCIPAL INVESTIGATOR

• Zuzana Nemethyova, MD

  Diabetology Dispensary Bratislava

  PRINCIPAL INVESTIGATOR

• Marta Ondrejkova, MD PhD.

  F.D. Roosevelt Hospital Banska Bystrica

  PRINCIPAL INVESTIGATOR

• Jana Stefanickova, MD

  University Hospital Bratislava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 5, 2014
• Study Start: February 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 22, 2016

Record last verified: 2016-09