Cardiovascular Risk Assesment in Diabetic Patients Via Lens Autofluorecscence Detection

• Conditions: Diabetic Patients With/Without Atherosclerotic Diseases
• Interventions: Other: Non interventional

• Registration Number: NCT02947555
• Lead Sponsor: Dr. Gergő Molnár

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.

Study Timeline

• Study Start: 2016-05-01
• Study First Submitted: 2016-09-22
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-10-28
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-22
• Last Update Posted: 2019-02-25
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 420

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DM+/AT+	Non interventional	Patients with type 2 diabetes mellitus and atherosclerotic event in history
DM-/AT+	Non interventional	Non-diabetic patients with atherosclerotic event in history
DM+/AT-	Non interventional	Patients with type 2 diabetes mellitus without atherosclerotic event in history
DM-/AT-	Non interventional	Non-diabetic patients without atherosclerotic event in history

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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)
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 CRP	2 years	Measurement of the autofluorescence of lens proteins and assessement of its association with CRP level

Trial Locations

Locations (1)

2nd Department of Medicine and Nephrological Center; 🇭🇺 Pécs, Baranya, Hungary