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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.

Key facts

Who runs it: University of Leicester
Where: Leicester, United KingdomSee the site
Trial code: NCT03132129
Registry title: Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus
Status: Recruiting
People taking part: 593 people, planned
Started: 24 Oct 2017
Expected to end: 31 Oct 2029
Type of study: Observational, 2 groups
Treatments tested: 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
Record updated: 5 January 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with stable type 2 diabetes who have no heart symptoms. They will have heart scans and tests to look for early heart problems.

Age: 18 to 75 years in the criteria; the registry fields list 50 to 75 years.
Sex: Men and women can join.
Disease stage: Stable type 2 diabetes, confirmed in GP records, by a diagnostic oral glucose tolerance test, or by glycated haemoglobin of 6.5% (48 mmol/mol) or higher. Mild breathlessness, heart disease without symptoms, obesity and high blood pressure do not rule people out.
Biomarker or test result: Glycated haemoglobin level of 6.5% (48 mmol/mol) or higher (or a record of a diagnostic oral glucose tolerance test).

Main reasons for not taking part

Angina or breathlessness that limits activity (worse than NYHA II)
Major atherosclerotic disease, such as a past heart attack, stroke or revascularisation
Atrial fibrillation or flutter
Moderate or severe heart valve disease
History of heart failure or cardiomyopathy

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

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%)

Who cannot take part

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

Check if you might fit

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?

Where in United Kingdom

University of LeicesterLeicester, United KingdomContact: Gaurav S Gulsin, MRCP(UK)Taking people

About the trial

What the trial wants to find out

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

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.

The 2 groups in the trial

Type 2 diabetics
Participants will be aged (≥18 and ≤75 years) with T2D and no prior history of cardiovascular disease.
Treatment: 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, and Blood tests
Healthy controls
Cases will be compared with age-, gender- and ethnicity-matched healthy controls.
Treatment: 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, and Blood tests