Understanding heart function in adults with type 2 diabetes
Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus
This study is trying to understand how type 2 diabetes affects heart health in adults by looking at heart function and structure using advanced imaging and tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 593 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | University of Leicester Academic / other |
| Locations | 1 site (Leicester) |
| Trial ID | NCT03132129 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 diagnosed with stable type 2 diabetes.
Not a fit: Patients with significant cardiovascular disease or other major health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and early detection of heart issues in patients with type 2 diabetes, potentially improving management and outcomes.
How similar studies have performed: Other studies have shown promising results in understanding cardiovascular dysfunction in diabetes, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Leicester
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.