Clinical trial NCT02947555: Cardiovascular Risk Assesment in Diabetic Patients Via Lens Autofluorecscence Detection
Official title: Cardiovascular Risk Assesment in Diabetic Patients Via Lens Autofluorecscence Detection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Patients With/Without Atherosclerotic Diseases
Keywords: diabetes mellitus
atherosclerosis
AGE
lens autofluorescence
Lead sponsor: University of Pecs
Sponsor class: OTHER
Collaborators: name: Bajcsy-Zsilinszky Kórház
name: Petz Aladar County Teaching Hospital
name: Vanderlich Egészségcentrum
name: Semmelweis University Heart and Vascular Center
name: Polytech Hungaria Kft.
First posted: 2016-10-28
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

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.

Eligibility 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)

Primary outcomes:
measure: Association of lens autofluorescence with atherosclerotic vascular events
timeFrame: 2 years
Secondary outcomes:
measure: Association of lens autofluorescence with the perscene of diabetes
timeFrame: 2 years
measure: Association of lens autofluorescence with renal function
timeFrame: 2 years
measure: Association of lens autofluorescence with glucose metabolism parameteres
timeFrame: 2 years
measure: Association of lens autofluorescence with lipid profile
timeFrame: 2 years
measure: Association of lens autofluorescence with CRP
timeFrame: 2 years
measure: Association of lens autofluorescence with antropoetric parameters
timeFrame: 2 years
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: 2nd Department of Medicine and Nephrological Center
state: Baranya
Study officials:
References: