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临床试验/NCT05324488
NCT05324488招募中不适用

Diabetes Registry Graz for Biomarker Research

Medical University of Graz1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2015年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
1
主要终点
Biomarker identification

研究概览

简要总结

The Diabetes registry for biomarker research Graz is a prospective cohort-study including subjects with type 1 and type 2 diabetes, rare types of diabetes, obesity and dyslipidemia, aiming to collect data, blood and urine samples of all subjects on an annual basis.

详细描述

Obesity and diabetes represent probably the most challenging threat to public health in the 21st century.

Despite well-controlled established cardiovascular risk factors, the residual risk in subjects with diabetes mellitus is significantly higher than the risk in those without the condition and it is well established that current risk prediction models for cardiovascular disease using established risk factors do not fully explain the future cardiovascular risk.

Therefore, biomarker for better risk stratification are needed, in particular in subjects with diabetes mellitus. Prospective cohorts, meticulously clinically phenotyping subjects, regularly following them and collecting biomarker samples is one key approach for finding new biomarker panels, that are predictive of treatment response and future micro- and macrovascular complications.

The Diabetes registry for Biomarker Research Graz was initiated in November 2015. Subjects with type 1 and type 2 diabetes, rare types of diabetes, obesity or dyslipidemia are recruited in the outpatient clinic for Diabetes, Lipid and Metabolic Disorders at the University Clinic Graz or in the Rehabilitation Center St. Radegund.

As of September 2021, 1250 subjects are recruited. Blood and urine samples samples are collected at baseline and at annual follow up visits as well as data on medical history, diagnoses and medication.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 - 99 years
  • Informed consent has to be given in written form
  • At least one of the following diseases:
  • Type 1 diabetes
  • Type 2 diabetes
  • Type 3 diabetes
  • Maturity onset diabetes of young (MODY)
  • Late onset diabetes of the adult (LADA)
  • Adipositas (BMI > 30kg/m2)
  • Lipid metabolism disorder

排除标准

  • No written informed consent
  • No willingness to participate in this registry

结局指标

主要结局

Biomarker identification

时间窗: Over entire period of registry (20 years)

Identification of biomarker panels that allow prediction of future micro- and macrovascular disease and events. Changes of these biomarkers over time in a selected, defined cohort will be reported.

次要结局

  • Biomarker validation(Over entire period of registry (20 years))

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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