NCT03132129 Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus
| NCT ID | NCT03132129 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Leicester |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | OBSERVATIONAL |
| Enrollment | 593 participants |
| Start Date | 2017-10-24 |
| Primary Completion | 2029-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 593 participants in total. It began in 2017-10-24 with a primary completion date of 2029-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Contact & Investigator
Gerry P McCann, MD
PRINCIPAL INVESTIGATOR
University of Leicester
Frequently Asked Questions
Who can join the NCT03132129 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 75 Years, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03132129 currently recruiting?
Yes, NCT03132129 is actively recruiting participants. Contact the research team at gpm12@le.ac.uk for enrollment information.
Where is the NCT03132129 trial being conducted?
This trial is being conducted at Leicester, United Kingdom.
Who is sponsoring the NCT03132129 clinical trial?
NCT03132129 is sponsored by University of Leicester. The principal investigator is Gerry P McCann, MD at University of Leicester. The trial plans to enroll 593 participants.
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