Diabetic RetinopathyDIARET SKNCT02232503
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
An observational study of Diabetic Retinopathy and Diabetic Macular Edema, run by Novartis Slovakia, s.r.o..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Diabetic Macular Edema, Diabetes Mellitus
- What is being tested?
- Studied cohort
- How many people
- 4,011 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
- Being tested
- Studied cohort
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Studied cohortGenetic
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The calculation of prevalence for each stage of DR will be analyzed using the same methods as for the total DR prevalence.
Measured: 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
The calculation of prevalence for each stage of DME will be analyzed using the same methods as for the total DR prevalence
Measured: 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
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.
Measured: participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startFeb 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 4,011 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Slovakia, s.r.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medirex Group Academy, Slovak Technical University, Comenius University
- Responsible party
- Sponsor
- Investigators
- Dagmar Buckova, M.D., Study director, Novartis SlovakiaPeter Carnogursky, MSc., Study director, Novartis Slovakia, s.r.o.Svetlana Sefcikova, MD, Study director, Novartis Slovakia, s.r.o.Pavol Tison, MD, Study director, Novartis Slovakia, s.r.o.Iveta Tvrda, MD, Study director, Novartis Slovakia, s.r.o.Daniela Gasperikova, MSc., PhD., Study director, Novartis Slovakia, s.r.o.Ivana Hojsikova, RNDr., Study director, Medirex Group AcademyLudevit Kadasi, RNDr., DrSc., Study director, Comenius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232503
- Sponsor's protocol ID
- CRFB002DSK01
- Acronym
- DIARET SK
- Status last verified
- Sep 2016
- First submitted
- 3 Sep 2014
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02232503
- Acronym / sponsor ID
- DIARET SK / CRFB002DSK01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,011 participants (actual)
- Lead sponsor
- Novartis Slovakia, s.r.o.Industry (pharma, biotech, devices)
- Collaborators
- Medirex Group Academy, Slovak Technical University, Comenius University
- Study start
- Feb 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 5 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Studied cohortFor 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. | Genetic | – |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dagmar Buckova, M.D. study director
Novartis Slovakia
Peter Carnogursky, MSc. study director
Novartis Slovakia, s.r.o.
Svetlana Sefcikova, MD study director
Novartis Slovakia, s.r.o.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy and Diabetic Macular Edema, run by Novartis Slovakia, s.r.o..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2016.