Diabetes Mellitus, Type 2 Clinical Trial
— PREDICTOfficial title:
Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus
NCT number | NCT03132129 |
Other study ID # | 0580 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 24, 2017 |
Est. completion date | October 31, 2029 |
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.
Status | Recruiting |
Enrollment | 593 |
Est. completion date | October 31, 2029 |
Est. primary completion date | October 31, 2029 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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%). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Leicester | Leicester |
Lead Sponsor | Collaborator |
---|---|
University of Leicester |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of early heart failure in type 2 diabetes | Proportion of participants with type 2 diabetes who have features of early heart failure | 5 years | |
Secondary | Multivariate and independent predictors of LV systolic and diastolic function in type 2 diabetes | Multivariate and independent predictors of LV systolic and diastolic function in type 2 diabetes | 3 years | |
Secondary | Sensitivity of CMR versus echocardiography and BNP for detecting subclinical cardiovascular dysfunction in type 2 diabetes | Sensitivity of CMR versus echocardiography and BNP for detecting subclinical cardiovascular dysfunction in type 2 diabetes | 3 years | |
Secondary | Independent association of CMR measures with aerobic exercise capacity in type 2 diabetes | Independent association of CMR measures (LV systolic and diastolic strain and strain rates) with aerobic exercise capacity (peak VO2) in type 2 diabetes | 3 years | |
Secondary | Differences in LV remodelling (indexed LV mass) between cases and controls | Differences in LV remodelling (indexed LV mass) between cases and controls | 3 years | |
Secondary | Independent clinical and imaging predictors of major adverse cardiovascular and, in particular, heart failure events in the patients with type 2 diabetes | Independent clinical and imaging predictors of major adverse cardiovascular and, in particular, heart failure events in the patients with type 2 diabetes | 5 years | |
Secondary | Differences in cardiac MRI and echo-derived systolic and diastolic strain and strain rates between cases and controls. | Differences in cardiac MRI and echo-derived systolic and diastolic strain and strain rates between cases and controls. | 3 years | |
Secondary | Differences in coronary atheroma burden (CT coronary artery calcium score) between cases and controls | Differences in coronary atheroma burden (CT coronary artery calcium score) between cases and controls | 3 years | |
Secondary | Differences in aerobic exercise capacity (peak V02) between cases and controls | Differences in aerobic exercise capacity (peak V02) between cases and controls | 3 years | |
Secondary | Differences in myocardial perfusion reserve between cases and controls | Differences in myocardial perfusion reserve between cases and controls | 3 years | |
Secondary | Differences in heart rate and blood pressure variability between cases and controls | Differences in heart rate and blood pressure variability between cases and controls | 3 years | |
Secondary | Myocardial steatosis | Myocardial steatosis as an independent predictor of LV global longitudinal strain | 3 years | |
Secondary | Myocardial calcium handling as assessed by manganese-enhanced magnetic resonance imaging (MEMRI) | Manganese influx constants calculated using Patlak modelling | 5 years | |
Secondary | Proteomic signature | Proteomic analysis will be conducted to identify a proteomic signature of early heart failure in type 2 diabetes that will be externally validated | 5 years | |
Secondary | Remission of type 2 diabetes | The phenotype of participants defined as in remission will be compared to active type 2 diabetes and healthy volunteers | 5 years |
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