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Cardiovascular Risk Assesment in Diabetic Patients Via Lens Autofluorecscence Detection

Cardiovascular Risk Assesment in Diabetic Patients Via Lens Autofluorecscence Detection

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02947555
Acronym
CRADILA
Enrollment
420
Registered
2016-10-28
Start date
2016-05-01
Completion date
2019-12-31
Last updated
2019-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Patients With/Without Atherosclerotic Diseases

Keywords

diabetes mellitus, atherosclerosis, AGE, lens autofluorescence

Brief 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.

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.

Interventions

OTHERNon interventional

Sponsors

Bajcsy-Zsilinszky Kórház
CollaboratorUNKNOWN
Petz Aladar County Teaching Hospital
CollaboratorOTHER
Vanderlich Egészségcentrum
CollaboratorUNKNOWN
Semmelweis University Heart and Vascular Center
CollaboratorOTHER
Polytech Hungaria Kft.
CollaboratorUNKNOWN
Dr. Gergő Molnár
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Association of lens autofluorescence with atherosclerotic vascular events2 yearsMeasurement of the autofluorescence of lens proteins and assessement of its association with the occurrance of atherosclerotic vascular events

Secondary

MeasureTime frameDescription
Association of lens autofluorescence with renal function2 yearsMeasurement of the autofluorescence of lens proteins and assessement of its association with renal function (eGFR)
Association of lens autofluorescence with glucose metabolism parameteres2 yearsMeasurement of the autofluorescence of lens proteins and assessement of its association with glucose metabolism parameteres (ex. HBA1C, HOMA IR)
Association of lens autofluorescence with the perscene of diabetes2 yearsMeasurement of the autofluorescence of lens proteins and assessement of its association with the persence of diabetes type 2 diabetes
Association of lens autofluorescence with CRP2 yearsMeasurement of the autofluorescence of lens proteins and assessement of its association with CRP level
Association of lens autofluorescence with antropoetric parameters2 yearsMeasurement of the autofluorescence of lens proteins and assessement of its association with antropometric parameteres (body weight, height, BMI, waist-hip ratio)
Association of lens autofluorescence with lipid profile2 yearsMeasurement of the autofluorescence of lens proteins and assessement of its association with serum lipid values (serum total cholesterol, triglycerids, LDL, HDL)

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026