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

February 22, 2019 updated by: Dr. Gergő Molnár
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

420

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
    • Baranya
      • Pécs, Baranya, Hungary, 7624
        • Recruiting
        • 2nd Department of Medicine and Nephrological Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association of lens autofluorescence with atherosclerotic vascular events
Time Frame: 2 years
Measurement of the autofluorescence of lens proteins and assessement of its association with the occurrance of atherosclerotic vascular events
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Gergő Molnár

Collaborators

Semmelweis University Heart and Vascular Center
Petz Aladar County Teaching Hospital
Bajcsy-Zsilinszky Kórház
Vanderlich Egészségcentrum
Polytech Hungaria Kft.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

September 22, 2016

First Submitted That Met QC Criteria

October 27, 2016

First Posted (Estimate)

October 28, 2016

Study Record Updates

Last Update Posted (Actual)

February 25, 2019

Last Update Submitted That Met QC Criteria

February 22, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PTEBEL 01/2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Patients With/Without Atherosclerotic Diseases

Clinical Trials on Non interventional

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe