Cardiovascular Risk Assesment in Diabetic Patients Via Lens Autofluorecscence Detection

Diabetic Patients With/Without Atherosclerotic Diseases Clinical Trial

— CRADILA  

Official title:

Cardiovascular Risk Assesment in Diabetic Patients Via Lens Autofluorecscence Detection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02947555
• Other study ID #: PTEBEL 01/2015
• Status: Recruiting
• Start date: May 1, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2019
• Source: University of Pecs
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetic Patients With/Without Atherosclerotic Diseases

Intervention

Other:
• Non interventional

Locations

Country	Name	City	State
Hungary	2nd Department of Medicine and Nephrological Center	Pécs	Baranya

Sponsors (6)

Lead Sponsor	Collaborator
Dr. Gergo Molnár	Bajcsy-Zsilinszky Kórház, Petz Aladar County Teaching Hospital, Polytech Hungaria Kft., Semmelweis University Heart and Vascular Center, Vanderlich Egészségcentrum

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of lens autofluorescence with atherosclerotic vascular events	Measurement of the autofluorescence of lens proteins and assessement of its association with the occurrance of atherosclerotic vascular events	2 years
Secondary	Association of lens autofluorescence with the perscene of diabetes	Measurement of the autofluorescence of lens proteins and assessement of its association with the persence of diabetes type 2 diabetes	2 years
Secondary	Association of lens autofluorescence with renal function	Measurement of the autofluorescence of lens proteins and assessement of its association with renal function (eGFR)	2 years
Secondary	Association of lens autofluorescence with glucose metabolism parameteres	Measurement of the autofluorescence of lens proteins and assessement of its association with glucose metabolism parameteres (ex. HBA1C, HOMA IR)	2 years
Secondary	Association of lens autofluorescence with lipid profile	Measurement of the autofluorescence of lens proteins and assessement of its association with serum lipid values (serum total cholesterol, triglycerids, LDL, HDL)	2 years
Secondary	Association of lens autofluorescence with CRP	Measurement of the autofluorescence of lens proteins and assessement of its association with CRP level	2 years
Secondary	Association of lens autofluorescence with antropoetric parameters	Measurement of the autofluorescence of lens proteins and assessement of its association with antropometric parameteres (body weight, height, BMI, waist-hip ratio)	2 years