CRADILA: Cardiovascular Risk Assesment in Diabetic Patients Via Lens Autofluorecscence Detection
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| DM+/AT+ Patients with type 2 diabetes mellitus and atherosclerotic event in history |
Other: Non interventional
|
| DM+/AT- Patients with type 2 diabetes mellitus without atherosclerotic event in history |
Other: Non interventional
|
| DM-/AT+ Non-diabetic patients with atherosclerotic event in history |
Other: Non interventional
|
| DM-/AT- Non-diabetic patients without atherosclerotic event in history |
Other: Non interventional
|
Outcome Measures
Primary Outcome Measures
- Association of lens autofluorescence with atherosclerotic vascular events [2 years]
Measurement of the autofluorescence of lens proteins and assessement of its association with the occurrance of atherosclerotic vascular events
Secondary Outcome Measures
- Association of lens autofluorescence with the perscene of diabetes [2 years]
Measurement of the autofluorescence of lens proteins and assessement of its association with the persence of diabetes type 2 diabetes
- Association of lens autofluorescence with renal function [2 years]
Measurement of the autofluorescence of lens proteins and assessement of its association with renal function (eGFR)
- Association of lens autofluorescence with glucose metabolism parameteres [2 years]
Measurement of the autofluorescence of lens proteins and assessement of its association with glucose metabolism parameteres (ex. HBA1C, HOMA IR)
- Association of lens autofluorescence with lipid profile [2 years]
Measurement of the autofluorescence of lens proteins and assessement of its association with serum lipid values (serum total cholesterol, triglycerids, LDL, HDL)
- Association of lens autofluorescence with CRP [2 years]
Measurement of the autofluorescence of lens proteins and assessement of its association with CRP level
- Association of lens autofluorescence with antropoetric parameters [2 years]
Measurement of the autofluorescence of lens proteins and assessement of its association with antropometric parameteres (body weight, height, BMI, waist-hip ratio)
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 2nd Department of Medicine and Nephrological Center | Pécs | Baranya | Hungary | 7624 |
Sponsors and Collaborators
- Dr. Gergő Molnár
- Bajcsy-Zsilinszky Kórház
- Petz Aladar County Teaching Hospital
- Vanderlich Egészségcentrum
- Semmelweis University Heart and Vascular Center
- Polytech Hungaria Kft.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PTEBEL 01/2015