- ICH GCP
- US Clinical Trials Registry
- 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 (DIARET SK)
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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:
- patients with DM duration more 20 years
- 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.
Description
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 Plan
How is the study designed?
Design Details
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The prevalence of diabetic retinopathy as the proportion of patients with DR (any stage) in a given subgroup according to DM duration
Time Frame: participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the prevalence and individual stages of Diabetic Retinopathy in patients with type 1 and type 2 DM verified based on complex ophthalmologic measurements
Time Frame: participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria
|
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
|
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
Time Frame: participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria
|
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
|
Evaluate the impact of risk factors on the prevalence of Diabetic Retinopathy and Diabetic Macular Edema
Time Frame: participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria
|
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
|
Evaluate the impact of diabetic retinopathy and diabetes mellitus on the Quality Of Life as measured by NEI-VFQ25 questionnaires
Time Frame: participants examined each working day within selected working hours during a 6 months period in selected ophthalmology centers according to protocol criteria
|
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
|
Investigate DNA polymorphisms and phenotypic features correlating with the development of DR in patients with extreme phenotypes.
Time Frame: DNA analysis during 7 months post study screening period
|
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
|
The analysis of mitochondrial DNA haplotypes in pre-defined patient groups
Time Frame: DNA analysis during 7 months post study screening period
|
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
|
The identification of patients with monogenic DM by biomarkers (hsCRP)
Time Frame: DNA analysis during 7 months post study screening period
|
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
|
Identification of patients with extreme phenotypes and family history of DM with eye complications
Time Frame: DNA analysis during 7 months post study screening period
|
DNA analysis during 7 months post study screening period
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: 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.
- Principal Investigator: 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRFB002DSK01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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