Cardiovascular Risk Assesment in Diabetic Patients Via Lens Autofluorecscence Detection (CRADILA)

Dr. Gergő Molnár

Status: Unknown

Conditions: Diabetic Patients With/Without Atherosclerotic Diseases

Treatments: Other: Non interventional

Study type: Observational

Funder types: Other

Identifiers

NCT02947555

PTEBEL 01/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 420 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

420 participants in 4 patient groups

DM+/AT+

Description:

Patients with type 2 diabetes mellitus and atherosclerotic event in history

Treatment:

Other: Non interventional

DM+/AT-

Description:

Patients with type 2 diabetes mellitus without atherosclerotic event in history

Treatment:

Other: Non interventional

DM-/AT+

Description:

Non-diabetic patients with atherosclerotic event in history

Treatment:

Other: Non interventional

DM-/AT-

Description:

Non-diabetic patients without atherosclerotic event in history

Treatment:

Other: Non interventional