Multifactorial Treatment of Cardiovascular Risk in Patients With Diabetes Mellitus Type-2: Identification of Treatment Non-Responders (The CARDIONOR Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Change of Intima Media Thickness (IMT)
研究概览
简要总结
The aim of the study is to develop a model that allows early identification of type-2 diabetic patients who will face progressive atherosclerosis despite intensive, multifactorial, target oriented treatment
详细描述
Background: Patients with type-2 diabetes face a substantially elevated risk for cardiovascular and cerebrovascular disease. This risk is based on traditional and non-traditional cardiovascular risk factors. It is, thus, partially mediated by modifiable conditions for instance blood pressure, cholesterol, or hyperglycemia. Indeed, controlled prospective intervention studies highlighted that individual lowering of those risk factors resulted in a reduction of vascular events such as acute coronary syndromes or stroke. The STENO-2 trial convincingly proved that multifactorial risk intervention, targeting all those risk factors substantially slowed the progression of atherosclerosis. As a result an even greater than 50 % reduction of vascular risk in patients with type-2 diabetes was observed. Thus, state of the art treatment for type-2 diabetic patients is multifactorial risk intervention targeting glucose control, lipids, blood pressure, platelets and the rennin-angiotensin-system.
Rationale: Risk normalisation for type-2 diabetic patients was not reached in the STENO-2 trial. In addition, it is, up to now, not possible to predict at early treatment stages who was to suffer progressive atherosclerosis and a future event despite intensive treatment of risk factors. Such early identification of treatment non-responders could enable to further intensify treatment or to develop new treatment strategies.
Aim: To develop a model that allows early identification of type-2 diabetic patients who will face progressive atherosclerosis despite intensive, multifactorial, target oriented treatment.
Experimental approach: To pursue the above mentioned aim, it will be investigated if, in patients with an indication to multifactorial risk intervention, either baseline characteristics or treatment responses after 3 months of intensified, multifactorial risk intervention can be used to predict progressive atherosclerosis during the study period of 2 years. To construct the model, traditional and non-traditional vascular risk factors will be evaluated.
Traditional vascular risk factors:
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus type-2
- •Indication to multifactorial risk intervention not in treatment target by means of two out of the following criteria:
- •Low Density Lipoprotein (LDL)-cholesterol > 120 mg/dl treated or untreated
- •Blood pressure: systolic >140 mmHg or diastolic >90 mmHg (office reading, treated or untreated)
- •(Glycated Hemoglobin) HbA1c > 7.5 % treated or untreated
- •Signed informed consent
- •Age 45 to 75 years
- •Body Mass Index (BMI) < 35 kg/m2
排除标准
- •History of any vascular event except angiography
- •Heart failure > New York Heart Association (NYHA) II
- •Serum Creatinine > 3.0 mg/dl
- •Triglycerides > 400 mg/dl
- •Aspartat-Aminotransferase (AST) / Alanin aminotransferase (ALT) > 3x Upper Limit of Normal (ULN)
- •Major psychiatric disorder
结局指标
主要结局
Change of Intima Media Thickness (IMT)
时间窗: 24 months (from Baseline Visit to Visit 24 months after Baseline)
Change of IMT from Baseline to 24 months
次要结局
未报告次要终点
研究者
Harald Sourij, MD
MD
Medical University of Graz