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临床试验/NL-OMON41247
NL-OMON41247招募中不适用

ovel diagnostic test to improve cardiovascular disease risk reduction in subjects with type 2 diabetes, increasing cost effectiveness and quality of life. - Improved CVD risk test in T2D.

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 1,500 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,500

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria:;- T2D patients with a glycated haemoglobin HbA1c level of >58 mmol/mole (or >7,5%).
  • T2D definition: T2D is the most common type of diabetes. In this condition, plasma glucose levels cannot be kept within the normal range. T2D is being developed due to a gradual decrease of insulin production by beta cells in the pancreas and/or due to a decrease of insulin sensitivity (insulin resistance). Causing a reduction in glucose uptake from the bloodstream. That can lead to continuously high glucose levels (hypertriglyceridemia). The diagnosis of T2D can be made according to fasting glucose levels >7.0 mmol/L. The golden standard is the Oral Glucose Tolerance Test (OGTT) where the glucose levels are being measured 2 hours after the ingestion of a glucose-load and have to be >11.1 mmol/L to makeobtain the diagnosis.;- Age > 18 years

排除标准

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:;- (potential) pregnancy (pregnancy / wishing to get pregnant / might be pregnant due for example loss of good anticonception).
  • In all these cases the women will be excluded from the study. The reason therefore is that the effect of cholesterol lowering treatment on the unborn infant has not been tested before, and therefore can potentially be harmful to the unborn infant. Women in the productive age will be asked about the possibility of pregnancy and the anticonception used, before they can be included in this study. (This procedure does not differ from usual care).
  • - Incapacitated subjects.
  • - Patients who allready partcipated in an another ongoing intervention study

研究者

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