Studies heart function in adults with type 2 diabetes without symptoms
Checks heart structure and function in adults with type 2 diabetes who have no symptoms.
Plain-language title generated from the registry record
Registry title: Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus
Key facts
- Where
- Leicester, United KingdomSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 75 years old?
Source: NCT03132129, who can take part
Where in United Kingdom
- University of LeicesterLeicester, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Leicester
- Trial code
- NCT03132129
- Record updated
- 5 January 2024
- Original description
Background: Heart failure is a major cause of morbidity and mortality in diabetes mellitus, but its pathophysiology is poorly understood.Read full original descriptionShow less
Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus
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.
Inclusion: 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: Major atherosclerotic disease: Symptomatic CAD, history of myocardial infarction, previous revascularisation, stroke/transient ischaemic attack or symptomatic peripheral vascular disease; Angina pectoris or limiting dyspnoea (>NYHA II),; Moderate or severe valvular heart disease; History of heart failure or cardiomyopathy; Type 1 diabetes mellitus (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; Atrial fibrillation or flutter; Low fasting C-peptide levels suggestive of adult-onset T1DM.