Asker and Baerum Cardiovascular Diabetes Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Reduction in 10-year absolute CHD risk
研究概览
简要总结
The purposes of this study are:
- to investigate the extent of cardiovascular complications in a representative cohort (n=135) of adult patients with type 2 diabetes;
- to examine if modern non-invasive assessment can replace invasive assessment;
- to determine the effects of a 6 month lifestyle interventional program on weight, glycemic control and lipids in 60 patients;
- to determine the effect of a 2-year prospective, randomised multi-interventional program (n=120) on cardiovascular risk, anthropometric measures and glycometabolic control; and
- to investigate inflammatory markers in this setting.
详细描述
As cardiovascular disease often is silent in type 2 diabetic patients, ways of detecting this early is of potential benefit, as is probably an aggressive treatment regimen trying to achieve goals for factors such as blood pressure, glycemic control, lipids, smoking, physical activity and weight.
This study compares traditional non-invasive tests such as stress-ecg, modern non-invasive tests such as holter-analysis, modern ECG analysis, stress-ecco cardiography and tissue Doppler against the gold standard today for assessing coronary artery disease, coronary angiography, in patients with type 2 diabetes and at least one cv-risk factor (i.e smoking, premature familial coronary artery disease (CAD)), hypertension) irrespective of symptoms or signs of CAD.
The participants are included in a randomized-control trial for 2 years where one arm receives standard treatment and one receives treatment after a multi-interventional program.
End-points include: glycemic control, lipid control, weight control, blood pressure control, and effects on inflammatory parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Patients were randomized to intensive care of standard care, outcomes were assessed by experts who where unaware of group allocation
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
- 否
入选标准
- •Type 2 diabetes
- •Ages 18-75 years
- •Men and women
- •At least one cardiovascular risk factor (i.e hypertension, dyslipidemia, smoking/formerly smoker, premature familial coronary artery disease [CAD], microalbuminuria)
- •Written informed consent given
排除标准
- •Unwillingness
- •Age < 18 or > 75 years
- •Unstable cardiovascular condition
- •Unstable medical condition
研究组 & 干预措施
Standard of care
Standard care with or without structured care according to national guidelines
干预措施: Combined lifestyle intervention and optimisation of pharmacological treatment (Drug)
Structured multi intervention
Structured multi intervention to reach predefined glycemic and blood pressure goals as well as activity and weight goal
干预措施: Combined lifestyle intervention and optimisation of pharmacological treatment (Drug)
结局指标
主要结局
Reduction in 10-year absolute CHD risk
时间窗: 2-year
次要结局
- Effects on cardiovascular events(5-year)
- Effects on hospitalisations(5-year)
- Effects on CV risk markers (HbA1c, lipids, blood pressure, inflammation, etc)(2 years and 5 years)
- Effects on health related quality of life(2 years and 5 years)
研究者
Odd Erik Johansen
Study director
Asker & Baerum Hospital