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Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus
NCT03132129 · University of Leicester
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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
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.
Study design
Enrollment target: 593 participants
Age groups: adult, older_adult
Timeline
Starts: 2017-10-24
Estimated completion: 2029-10-31
Last updated: 2024-01-05
Interventions
Diagnostic Test: Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopyDiagnostic Test: Transthoracic echocardiographyDiagnostic Test: Computed tomography coronary artery calcium scoringDiagnostic Test: Cardiopulmonary exercise testingDiagnostic Test: Manganese-enhanced magnetic resonance imaging (MEMRI)Diagnostic Test: Ambulatory blood pressure monitoringDiagnostic Test: Accelerometer watchDiagnostic Test: Blood tests
Primary outcomes
- • Prevalence of early heart failure in type 2 diabetes (5 years)
Sponsor
University of Leicester · other
Contacts & investigators
ContactGerry P McCann, MD · contact · gpm12@le.ac.uk · 01162583402
ContactGaurav S Gulsin, MBChB(Hons) · contact · gg149@leicester.ac.uk · 01162583244
InvestigatorGerry P McCann, MD · principal_investigator, University of Leicester
All locations (1)
University of LeicesterRecruiting
Leicester, United Kingdom