Arterial Stiffness and Complication Risk in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Albuminuria
研究概览
简要总结
Background
The prevalence and incidence of type 2 diabetes is increasing globally. A common complication of diabetes is the disease of the blood vessels, vascular diseases, which can cause disorders like myocardial infarction, stroke and kidney failure. Methods to detect early subclinical stages of macro-vascular disease are not yet available in a clinical setting.
Hypothesis
Arterial stiffness, an easy accessible vascular parameter, may provide additional prognostic information when evaluating risk profile for patients with diabetes type 2.
Aim
The aim of the project is to investigate the association between arterial stiffness and the occurrence and development of vascular complications in patients with type 2 diabetes. Specifically we want to investigate:
- in a cross-sectional study, the association between arterial stiffness and subclinical atherosclerotic changes in the coronary arteries assessed by computed tomography (CT) and
- in a longitudinal study, the predictive value of arterial stiffness on the development of subclinical cerebrovascular changes assessed by magnetic resonance imaging (MRI) and nephropathy assessed by urine analysis.
Methods
The study population consists of 100 patients with newly diagnosed type 2 diabetes and 100 age- and sex matched controls. The study participants were enrolled between 2008-2011 and extensively characterized i.a. with arterial stiffness (pulse wave velocity), MRI (white matter lesions and cerebral infarctions) and urine analysis (albuminuria). In this study we will enrol the same patients in a 5 year follow-up study in order to repeat above mentioned measurements. Furthermore, CT is used to investigate the coronary plaque burden of the participants (Agatston Score and Segment Involvement Score).
Results and Perspective
This project adds new insight into arterial stiffness as a predictor of the progression of micro- and macrovascular complications in patients with type 2 diabetes, and can potentially improve risk stratification and early strategies of intervention in this patient group.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age
- •Diabetes, type 2, diagnosed within 5 years from baseline (cases)
排除标准
- •Non-diagnosed diabetes (healthy controls)
- •Acute or chronic infectious diseases
- •Kidney failure (requiring dialysis)
- •Pregnancy/breastfeeding
- •Prior or concomitant cancer disease
- •Contraindication for MRI (claustrophobia, magnetic implants or bodyweight above 120kg)
- •Contraindication for CT (estimated glomerular filtration rate < 50 ml/min, Body Mass Index > 35 kg/m2, heart arrhythmia, heart failure, aorta stenosis, contraindications for beta blockage or nitroglycerin or failure to cooperate)
结局指标
主要结局
Albuminuria
时间窗: 5 years
A measure of kidney damage
Segment Involvement Score (CT)
时间窗: Will be assessed within 3 weeks from enrollment
Measure of coronary plaques and a surrogate marker of ischemic heart disease.
Agatston Score (CT)
时间窗: Will be assessed within 3 weeks from enrollment
Measure of calcium in the coronary arteries and a surrogate marker of ischemic heart disease
White matter lesions (MRI)
时间窗: 5 years
A surrogate marker of the risk of stroke
次要结局
未报告次要终点