Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus (PREDICT)

University of Leicester

Status: Enrolling

Conditions: Diabetic Cardiomyopathies; Diabetes Mellitus, Type 2

Treatments: Diagnostic Test: Manganese-enhanced magnetic resonance imaging (MEMRI); Diagnostic Test: Accelerometer watch; Diagnostic Test: Computed tomography coronary artery calcium scoring; Diagnostic Test: Blood tests; Diagnostic Test: Ambulatory blood pressure monitoring; Diagnostic Test: Cardiopulmonary exercise testing; Diagnostic Test: Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy; Diagnostic Test: Transthoracic echocardiography

Study type: Observational

Funder types: Other

Identifiers

NCT03132129

0580

Details and patient eligibility

About

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.

Enrollment: 593 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

593 participants in 2 patient groups

Type 2 diabetics

Description:

Participants will be aged (≥18 and ≤75 years) with T2D and no prior history of cardiovascular disease.

Treatment:

Diagnostic Test: Cardiopulmonary exercise testing

Diagnostic Test: Ambulatory blood pressure monitoring

Diagnostic Test: Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy

Diagnostic Test: Blood tests

Diagnostic Test: Manganese-enhanced magnetic resonance imaging (MEMRI)

Diagnostic Test: Accelerometer watch

Diagnostic Test: Computed tomography coronary artery calcium scoring

Diagnostic Test: Transthoracic echocardiography

Healthy controls

Description:

Cases will be compared with age-, gender- and ethnicity-matched healthy controls.

Treatment:

Diagnostic Test: Cardiopulmonary exercise testing

Diagnostic Test: Ambulatory blood pressure monitoring

Diagnostic Test: Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy

Diagnostic Test: Blood tests

Diagnostic Test: Manganese-enhanced magnetic resonance imaging (MEMRI)

Diagnostic Test: Accelerometer watch

Diagnostic Test: Computed tomography coronary artery calcium scoring

Diagnostic Test: Transthoracic echocardiography