Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 593
- 试验地点
- 1
- 主要终点
- Prevalence of early heart failure in type 2 diabetes
研究概览
简要总结
Background: Heart failure is a major cause of morbidity and mortality in diabetes mellitus, but its pathophysiology is poorly understood.
Aim: To determine the prevalence and determinants of subclinical cardiovascular dysfunction in adults with type 2 diabetes (T2D).
Plan: 518 asymptomatic adults (aged 18-75 years) with T2D will undergo comprehensive evaluation of cardiac structure and function using cardiac MRI (CMR) and spectroscopy, echocardiography, CT coronary calcium scoring, exercise tolerance testing and blood sampling. 75 controls will undergo the same evaluation.
Primary hypothesis: myocardial steatosis is an independent predictor of left ventricular global longitudinal strain. Secondary hypotheses: will assess whether CMR is more sensitive to detect early cardiac dysfunction than echocardiography and BNP, and whether cardiac dysfunction is related to peak oxygen consumption.
Expected value of results: This study will reveal the prevalence and determinants of cardiac dysfunction in T2D, and could provide targets for novel therapies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged ≥18 and ≤75 years.
- •Diagnosed with Stable type 2 diabetes (determined by: i) formal diagnosis in GP case records, ii) a record of diagnostic oral glucose tolerance test OR glycated haemoglobin level ≥6.5%).
排除标准
- •Angina pectoris or limiting dyspnoea (>NYHA II),
- •Major atherosclerotic disease: Symptomatic CAD, history of myocardial infarction, previous revascularisation, stroke/transient ischaemic attack or symptomatic peripheral vascular disease.
- •Atrial fibrillation or flutter.
- •Moderate or severe valvular heart disease.
- •History of heart failure or cardiomyopathy.
- •Type 1 diabetes mellitus (T1DM).
- •Low fasting C-peptide levels suggestive of adult-onset T1DM.
- •Stage III-V renal disease (estimated glomerular filtration rate ≤30ml/min/1.73m2).
- •Absolute contraindications to CMR.
- •Importantly, patients with subclinical CAD, and other common comorbidities such as obesity and hypertension, will not be excluded from this study. This will enable us to evaluate the contribution of CAD to myocardial dysfunction in diabetes and ensures our study group is representative of the general population with diabetes. Similarly, as mild dyspnoea is extremely common and non-specific participants with mild dyspnoea will be included.
结局指标
主要结局
Prevalence of early heart failure in type 2 diabetes
时间窗: 5 years
Proportion of participants with type 2 diabetes who have features of early heart failure
次要结局
- Independent clinical and imaging predictors of major adverse cardiovascular and, in particular, heart failure events in the patients with type 2 diabetes(5 years)
- Differences in cardiac MRI and echo-derived systolic and diastolic strain and strain rates between cases and controls.(3 years)
- Multivariate and independent predictors of LV systolic and diastolic function in type 2 diabetes(3 years)
- Sensitivity of CMR versus echocardiography and BNP for detecting subclinical cardiovascular dysfunction in type 2 diabetes(3 years)
- Independent association of CMR measures with aerobic exercise capacity in type 2 diabetes(3 years)
- Differences in LV remodelling (indexed LV mass) between cases and controls(3 years)
- Differences in coronary atheroma burden (CT coronary artery calcium score) between cases and controls(3 years)
- Differences in aerobic exercise capacity (peak V02) between cases and controls(3 years)
- Differences in myocardial perfusion reserve between cases and controls(3 years)
- Differences in heart rate and blood pressure variability between cases and controls(3 years)
- Myocardial steatosis(3 years)
- Myocardial calcium handling as assessed by manganese-enhanced magnetic resonance imaging (MEMRI)(5 years)
- Proteomic signature(5 years)
- Remission of type 2 diabetes(5 years)