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
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
-
-
Baranya
-
Pécs, Baranya, Hungary, 7624
- Recruiting
- 2nd Department of Medicine and Nephrological Center
-
Contact:
- Gergo A Molnar, MD, PhD
- Phone Number: +3672536050
- Email: gergo.molnar@aok.pte.hu
-
Contact:
- Eszter Sélley, MD
- Phone Number: +3672536050
- Email: eszter.selley@aok.pte.hu
-
-
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
|
|
|
DM+/AT-
Patients with type 2 diabetes mellitus without atherosclerotic event in history
|
|
|
DM-/AT+
Non-diabetic patients with atherosclerotic event in history
|
|
|
DM-/AT-
Non-diabetic patients without atherosclerotic event in history
|
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.
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
Other Study ID Numbers
- PTEBEL 01/2015
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