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临床试验/NCT02947555
NCT02947555Unknown不适用

Cardiovascular Risk Assesment in Diabetic Patients Via Lens Autofluorecscence Detection

Dr. Gergő Molnár1 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2016年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
420
试验地点
1
主要终点
Association of lens autofluorescence with atherosclerotic vascular events

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • patient did not signe informed consent
  • after cataract operation, after optical operation, after sclera injury
  • fluorescein angiograpy performed in 6 months
  • diseases affecting the eye surface( sleritis, Sjogren sy)

结局指标

主要结局

Association of lens autofluorescence with atherosclerotic vascular events

时间窗: 2 years

Measurement of the autofluorescence of lens proteins and assessement of its association with the occurrance of atherosclerotic vascular events

次要结局

  • Association of lens autofluorescence with lipid profile(2 years)
  • Association of lens autofluorescence with the perscene of diabetes(2 years)
  • Association of lens autofluorescence with renal function(2 years)
  • Association of lens autofluorescence with antropoetric parameters(2 years)
  • Association of lens autofluorescence with glucose metabolism parameteres(2 years)
  • Association of lens autofluorescence with CRP(2 years)

研究者

发起方
Dr. Gergő Molnár
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Gergő Molnár

senior lecturer, University of Pécs

University of Pecs

研究点 (1)

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