Diabetic Patients With/Without Atherosclerotic DiseasesCRADILANCT02947555
Cardiovascular Risk Assesment in Diabetic Patients Via Lens Autofluorecscence Detection
An observational study of Diabetic Patients With/Without Atherosclerotic Diseases, run by Dr. Gergő Molnár at 1 site in Hungary.
Trial summary
The rate of lens autofluorescence will be compared in diabetic and non diabetic patients with/without atherosclerotic vascular diseases to evaluate if it is associated with the risk of cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Patients With/Without Atherosclerotic Diseases
- What is being tested?
- Non interventional
- How many people
- 420 participants
- Where
- 1 siteHungary
- Study dates
- 1 May 2016to 31 Dec 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-75 years either wit type 2 diabetes or non-diabetic, either having atherosclerotic vascular events in history or not (ACS, angina pectoris, stroke, TIA, clinically symptomatic PAD, atherosclerosis based amputation, stent implantation, angiplasty) Diabetes present for more than 1 year.
Who may be able to join
- Patients aged 18-75 years either wit type 2 diabetes or non-diabetic, either having atherosclerotic vascular events in history or not (ACS, angina pectoris, stroke, TIA, clinically symptomatic PAD, atherosclerosis based amputation, stent implantation, angiplasty) Diabetes present for more than 1 year.
Who cannot join
- patient did not signe informed consent
- cataract
- after cataract operation, after optical operation, after sclera injury
- fluorescein angiograpy performed in 6 months
- diseases affecting the eye surface( sleritis, Sjogren sy)
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
2nd Department of Medicine and Nephrological Center
Pécs, Baranya, 7624
Gergo A Molnar, MD, PhD, +3672536050, gergo.molnar@aok.pte.hu
Eszter Sélley, MD, +3672536050, eszter.selley@aok.pte.hu
About this study
The rate of lens autofluorescence will be compared in diabetic and non diabetic patients with/without atherosclerotic vascular diseases to evaluate if it is associated with the risk of cardiovascular diseases.
Read the detailed description
The rate of lens autofluorescensce is associated with the accumulation of advanced glication endproducts (AGE).The concetration of AGE increases with age but is also higher in diabetic patients. There is evidence that diabetes could be diagnosed via the detection of lens autofluorescence. The investigators are planning a cross sectional clinical trial to evaluate if the rate of lens autofluorescence could be associated with the clinical appearance of atherosclerotic vascular diseases in diabetic/non-diabetic patients and in patients who already had atherosclerotic vascular events and patients without previous atherosclerotic events. The cardiovascular and metabolic histoty of patients will be evaluated using a questionaire. Antropometrical data, blood pressure, heart rate, glucose metabolism, serum lipid profile, CRP, serum creatinine (eGFR) will be assased. ClearPath DS-120 biomicroscopical optical system (Freedom Meditech, San Diego, CA, USA) will be used for the measurment of lens autofluorescence. The measurement will be performed on one eye. Data of the different patient groups will be compared using ANOVA, a value of p<0.05 will be considered significant.
- Being tested
- Non interventional
- Keywords
- diabetes mellitus, atherosclerosis, AGE, lens autofluorescence
- Medical subject headings
- Diabetes Mellitus, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventionalOther
| Study group | Role | What they receive |
|---|---|---|
| DM+/AT+ | Patients with type 2 diabetes mellitus and atherosclerotic event in history Receives: Other: Non interventional | |
| DM+/AT- | Patients with type 2 diabetes mellitus without atherosclerotic event in history Receives: Other: Non interventional | |
| DM-/AT+ | Non-diabetic patients with atherosclerotic event in history Receives: Other: Non interventional | |
| DM-/AT- | Non-diabetic patients without atherosclerotic event in history Receives: Other: Non interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of lens autofluorescence with atherosclerotic vascular events
Measurement of the autofluorescence of lens proteins and assessement of its association with the occurrance of atherosclerotic vascular events
Measured: 2 years
Secondary outcomes (6)
Association of lens autofluorescence with the perscene of diabetes
Measurement of the autofluorescence of lens proteins and assessement of its association with the persence of diabetes type 2 diabetes
Measured: 2 years
Association of lens autofluorescence with renal function
Measurement of the autofluorescence of lens proteins and assessement of its association with renal function (eGFR)
Measured: 2 years
Association of lens autofluorescence with glucose metabolism parameteres
Measurement of the autofluorescence of lens proteins and assessement of its association with glucose metabolism parameteres (ex. HBA1C, HOMA IR)
Measured: 2 years
Association of lens autofluorescence with lipid profile
Measurement of the autofluorescence of lens proteins and assessement of its association with serum lipid values (serum total cholesterol, triglycerids, LDL, HDL)
Measured: 2 years
Association of lens autofluorescence with CRP
Measurement of the autofluorescence of lens proteins and assessement of its association with CRP level
Measured: 2 years
Association of lens autofluorescence with antropoetric parameters
Measurement of the autofluorescence of lens proteins and assessement of its association with antropometric parameteres (body weight, height, BMI, waist-hip ratio)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study start1 May 2016
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Patients With/Without Atherosclerotic DiseasesStudies 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Gergő Molnár
- Sponsor type
- University, hospital or other
- Collaborators
- Bajcsy-Zsilinszky Kórház, Petz Aladar County Teaching Hospital, Vanderlich Egészségcentrum, Semmelweis University Heart and Vascular Center, Polytech Hungaria Kft.
- Responsible party
- Sponsor-investigator, Dr. Gergő Molnár, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947555
- Sponsor's protocol ID
- PTEBEL 01/2015
- Acronym
- CRADILA
- Status last verified
- Feb 2019
- First submitted
- 22 Sep 2016
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Assesment in Diabetic Patients Via Lens Autofluorecscence Detection
- ClinicalTrials.gov ID
- NCT02947555
- Acronym / sponsor ID
- CRADILA / PTEBEL 01/2015
- Keywords
- diabetes mellitus, atherosclerosis, AGE, lens autofluorescence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Dr. Gergő MolnárUniversity, hospital or other
- Collaborators
- Bajcsy-Zsilinszky Kórház, Petz Aladar County Teaching Hospital, Vanderlich Egészségcentrum, Semmelweis University Heart and Vascular Center, Polytech Hungaria Kft.
- Study start
- 1 May 2016
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 28 Oct 2016 (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 rate of lens autofluorescence will be compared in diabetic and non diabetic patients with/without atherosclerotic vascular diseases to evaluate if it is associated with the risk of cardiovascular diseases.
Detailed description
The rate of lens autofluorescensce is associated with the accumulation of advanced glication endproducts (AGE).The concetration of AGE increases with age but is also higher in diabetic patients. There is evidence that diabetes could be diagnosed via the detection of lens autofluorescence. The investigators are planning a cross sectional clinical trial to evaluate if the rate of lens autofluorescence could be associated with the clinical appearance of atherosclerotic vascular diseases in diabetic/non-diabetic patients and in patients who already had atherosclerotic vascular events and patients without previous atherosclerotic events. The cardiovascular and metabolic histoty of patients will be evaluated using a questionaire. Antropometrical data, blood pressure, heart rate, glucose metabolism, serum lipid profile, CRP, serum creatinine (eGFR) will be assased. ClearPath DS-120 biomicroscopical optical system (Freedom Meditech, San Diego, CA, USA) will be used for the measurment of lens autofluorescence. The measurement will be performed on one eye. Data of the different patient groups will be compared using ANOVA, a value of p<0.05 will be considered significant.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DM+/AT+ | – | Other: Non interventionalPatients with type 2 diabetes mellitus and atherosclerotic event in history |
| DM+/AT- | – | Other: Non interventionalPatients with type 2 diabetes mellitus without atherosclerotic event in history |
| DM-/AT+ | – | Other: Non interventionalNon-diabetic patients with atherosclerotic event in history |
| DM-/AT- | – | Other: Non interventionalNon-diabetic patients without atherosclerotic event in history |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-75 years either wit type 2 diabetes or non-diabetic, either having atherosclerotic vascular events in history or not (ACS, angina pectoris, stroke, TIA, clinically symptomatic PAD, atherosclerosis based amputation, stent implantation, angiplasty) Diabetes present for more than 1 year.
Key inclusion criteria (1 listed)
- Patients aged 18-75 years either wit type 2 diabetes or non-diabetic, either having atherosclerotic vascular events in history or not (ACS, angina pectoris, stroke, TIA, clinically symptomatic PAD, atherosclerosis based amputation, stent implantation, angiplasty) Diabetes present for more than 1 year.
Key exclusion criteria (5 listed)
- patient did not signe informed consent
- cataract
- after cataract operation, after optical operation, after sclera injury
- fluorescein angiograpy performed in 6 months
- diseases affecting the eye surface( sleritis, Sjogren sy)
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 |
|---|---|---|
| Non interventional | Other | DM+/AT+, DM+/AT-, DM-/AT+, DM-/AT- |
Primary outcome
Association of lens autofluorescence with atherosclerotic vascular events
Time frame: 2 years
Measurement of the autofluorescence of lens proteins and assessement of its association with the occurrance of atherosclerotic vascular events
6 secondary outcomes
Association of lens autofluorescence with the perscene of diabetes
Time frame: 2 years
Association of lens autofluorescence with renal function
Time frame: 2 years
Association of lens autofluorescence with glucose metabolism parameteres
Time frame: 2 years
Association of lens autofluorescence with lipid profile
Time frame: 2 years
Association of lens autofluorescence with CRP
Time frame: 2 years
Association of lens autofluorescence with antropoetric parameters
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Patients With/Without Atherosclerotic Diseases, run by Dr. Gergő Molnár at 1 site in Hungary.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of lens autofluorescence with atherosclerotic vascular events (time frame: 2 years). 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 25 Feb 2019.