Cardiovascular Risk Assesment in Diabetic Patients Via Lens Autofluorecscence Detection

NCT ID: NCT02947555

Last Updated: 2019-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

420 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Diabetic Patients With/Without Atherosclerotic Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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DM+/AT+

Patients with type 2 diabetes mellitus and atherosclerotic event in history

Non interventional

Intervention Type OTHER

DM+/AT-

Patients with type 2 diabetes mellitus without atherosclerotic event in history

Non interventional

Intervention Type OTHER

DM-/AT+

Non-diabetic patients with atherosclerotic event in history

Non interventional

Intervention Type OTHER

DM-/AT-

Non-diabetic patients without atherosclerotic event in history

Non interventional

Intervention Type OTHER

Interventions

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Non interventional

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bajcsy-Zsilinszky Kórház

UNKNOWN

Sponsor Role collaborator

Petz Aladar County Teaching Hospital

OTHER

Sponsor Role collaborator

Vanderlich Egészségcentrum

UNKNOWN

Sponsor Role collaborator

Semmelweis University Heart and Vascular Center

OTHER

Sponsor Role collaborator

Polytech Hungaria Kft.

UNKNOWN

Sponsor Role collaborator

Dr. Gergő Molnár

OTHER

Sponsor Role lead

Responsible Party

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Dr. Gergő Molnár

senior lecturer, University of Pécs

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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2nd Department of Medicine and Nephrological Center

Pécs, Baranya, Hungary

Site Status RECRUITING

Countries

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Hungary

Facility Contacts

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Gergo A Molnar, MD, PhD

Role: primary

+3672536050

Eszter Sélley, MD

Role: backup

+3672536050

Other Identifiers

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PTEBEL 01/2015

Identifier Type: -

Identifier Source: org_study_id

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