Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-75
SponsorUniversity of Leicester
About this trial
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.
Eligibility criteria
Qualifiers
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%).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy
- Transthoracic echocardiography
- Computed tomography coronary artery calcium scoring
- Cardiopulmonary exercise testing
- Manganese-enhanced magnetic resonance imaging (MEMRI)
- Ambulatory blood pressure monitoring
- Accelerometer watch
- Blood tests
Treatment groups
593 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov