Carotid Intimae-media Thickness (CIMT) and Carotid Plaque (CP) Presence as Risk Markers of Cardiovascular Disease at the Time of Type 2 Diabetes Diagnosis
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Carotid Plaque presence(CP)
研究概览
简要总结
It has been hypothesized, based on recent trials, that only early intervention can reduce cardiovascular morbidity and mortality in individuals with type 2 diabetes (T2DM). This finding may imply that atherosclerosis at diabetes diagnosed, is either negligible, or at early, or non-advanced, still modifiable disease stage. However, sparse information is available regarding atherosclerosis prevalence and its characteristics at diabetes presentation. Furthermore, although cardiovascular disease (CVD) prevention is the major goal of treatment in T2DM, risk assessment tools, mostly based on traditional CV risk factors, lack of adequate specificity to identify individuals at higher risk. Therefore, non-invasive tests, such as carotid ultrasound, have been recommended to better define CV risk in several groups of individuals, including those with intermediate risk or with T2DM.
This clinical study aims to improve the investigators knowledge on cardiovascular disease (CVD) in subjects with newly diagnosed T2DM (NEWDM). The investigators hypothesis is that carotid ultrasound (carotid intimae media thickness [CIMT] and carotid plaque [CP]) will show a worse subclinical/preclinical CVD stage in NEWDM compared with non-diabetic (CONTROL) individuals. Moreover, carotid ultrasound will also identify T2DM individuals at a higher risk in whom intervention should be more intensive.
Because individuals with T2DM have a higher prevalence of several CV risk factors, NEWDM will be matched with CONTROL individuals, not only for age and sex (the main determinants of atherosclerosis), but also for known, treated hypertension and dyslipidemia, and smoking habit.
The investigators will study NEWDM and CONTROL individuals without clinical CVD. This is a cross-sectional and longitudinal (18 months of follow-up) case-control study. The main study variables will be carotid ultrasound derived variables. The main aims of the study are: 1) to investigate CIMT and CP prevalence differences between NEWDM and CONTROL subjects; 2) to characterize the subset of NEWDM subjects with a higher CIMT (≥ mean+1SD o ≥ P75th) or CP presence; and 3) to early characterize individuals in whom subclinical CVD worsens (CIMT progression ≥ mean + 1SD o ≥ P75th) even after standard (according to clinical guidelines) diabetes treatment.
详细描述
Hypothesis:
In a Mediterranean population, the investigators hypothesized that the CIMT and the presence of carotid plaque (CP):
- Are higher in patients with newly diagnosed T2DM than in a control population before and after adjusting for cardiovascular risk factors,
- Can identify subjects with T2DM with increased cardiovascular risk at the beginning of the disease, and,
- Can identify subjects in whom subclinical cardiovascular disease progresses despite treatment of T2DM according to clinical practice.
Aims:
Primary objectives:
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
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women older than 40 years and less than 75 years.
- •Newly Diagnosed T2DM (NEWDM). NEWDM is a subject without previous history of diabetes who has laboratory evidence consistent with diabetes (American Diabetes Association) within the last year.
- •Exclusion criteria:
- •Previous cardiovascular events such as, but not limited to, myocardial infarction, acute coronary syndrome or chronic stroke, peripheral arterial disease, or revascularization surgery in any territory.
- •Congestive heart failure (class III-IV).
- •Cancer of any kind (except basal cell or for cervical carcinoma insitu) unless disease free is documented in the past five years.
- •Anemia or known coagulopathy.
- •Serum creatinine greater than 1.5 mg / dl or MDRD (Modification of Diet in Renal Disease) equation <
- •Any organ transplant (except cornea)
- •Known HIV-positive, active tuberculosis, malaria, chronic viral hepatitis B or C, cirrhosis of any aetiology.
- •Pregnant or gestational idea in the next 2-3 years to inclusion.
- •History of alcohol dependence (or abusive consumption) or other drugs in the past five years.
- •Psychiatric illness that would entail adherence problems.
- •Participation in a clinical trial protocol or investigational drugs.
- •Debilitating chronic illness or short life expectancy to prevent adherence or therapeutic intensification is not the goal of managing your diabetes.
- •ECG signs of ischemic heart disease.
- •Diabetes type 1 or anti-GAD antibody positive.
- •Control population will be excluded based on the same criteria.
排除标准
- 未提供
结局指标
主要结局
Carotid Plaque presence(CP)
时间窗: Baseline
To investigate CP prevalence differences between NEWDM and CONTROL subjects
Carotid Intima Media Thickness (CIMT)
时间窗: Baseline
Compound CIMT (common carotid, bulb and internal carotid) differences between NEWDM and CONTROL.
次要结局
- CIMT(Baseline)
- Changes in plaque height(Baseline to 18 months)
- Changes in CIMT at different territories(Baseline to 18 months)
- Changes in lifestyle(Baseline to 18 months)
研究者
Emilio Ortega Martínez de Victoria
Senior Endocrinologist, MD, PhD
Hospital Clinic of Barcelona