Actively Recruiting
Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus
Led by University of Leicester · Updated on 2024-01-05
593
Participants Needed
1
Research Sites
627 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 60 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 60.5%).
You will not qualify if you...
- Angina pectoris or limiting dyspnoea (>NYHA II).
- Major atherosclerotic disease: Symptomatic coronary artery disease, 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.
- Low fasting C-peptide levels suggestive of adult-onset type 1 diabetes mellitus.
- Stage III-V renal disease (estimated glomerular filtration rate 60 30ml/min/1.73m2).
- Absolute contraindications to cardiovascular magnetic resonance imaging.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Leicester
Leicester, United Kingdom
Actively Recruiting
Research Team
G
Gerry P McCann, MD
CONTACT
G
Gaurav S Gulsin, MBChB(Hons)
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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