Understanding heart function in adults with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to determine the prevalence and factors contributing to subclinical cardiovascular dysfunction in adults aged 18-75 with type 2 diabetes mellitus. A total of 518 asymptomatic participants will undergo a comprehensive evaluation of cardiac structure and function using advanced imaging techniques such as cardiac MRI, echocardiography, and CT coronary calcium scoring. The study will also include exercise tolerance testing and blood sampling to assess various cardiac health indicators. The primary focus is to explore the relationship between myocardial steatosis and left ventricular function, while also comparing the sensitivity of different imaging modalities in detecting early cardiac dysfunction.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Leicester
  Leicester, United Kingdom Recruiting

Study contacts

• Principal investigator: Gerry P McCann, MD — University of Leicester
• Study coordinator: Gerry P McCann, MD
• Email: gpm12@le.ac.uk
• Phone: 01162583402

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.