At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy (diagnostic test), Transthoracic echocardiography (diagnostic test), Computed tomography coronary artery calcium scoring (diagnostic test), Cardiopulmonary exercise testing (diagnostic test)
- How long the study runs
- Study runs about 144 months (dates as stated)
- About the drug or intervention
- Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy — diagnostic test: CMR scanning performed on a 3T MRI scanner. · Transthoracic echocardiography — diagnostic test: Comprehensive transthoracic echocardiography, including: tissue Doppler indices of diastolic filling and speckle tracking for systolic and diastolic strain/strain rate, exclusion of valvular abnormalities, assessment of LV size and function. · Computed tomography coronary artery calcium scoring — diagnostic test: Computed Tomography coronary calcium scoring to assess the presence of subclinical atherosclerosis and allow an estimate of atheroma burden in addition to epicardial adipose tissue characterisation and systolic strain. · Cardiopulmonary exercise testing — diagnostic test: Physician supervised incremental symptom limited cardiopulmonary exercise tolerance test with ECG and haemodynamic monitoring. · Manganese-enhanced magnetic resonance imaging (MEMRI) — diagnostic test: A subset of the participants will have cardiac MRI scanning with manganese-based contrast agent, lasting approximately 45-50 minutes. · Ambulatory blood pressure monitoring — diagnostic test: A 24-hour blood pressure monitor will be worn at the end of the visit to the following day. · Accelerometer watch — diagnostic test: Watch worn to collect free living physical activity data for 7 days. · Blood tests — diagnostic test: Collection of blood samples from each participant to characterise the participant's health status and to develop a proteomic signature of early heart failure.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 50 Years to 75 Years
- Who
- All
- Number of participants
- 593
- Started
- 2017-10-24
- Last checked
- 2024-01
Plain English Summary
What is this study?
- • Testing a new treatment for diabetes mellitus, type 2
- • Clinical study - 593 participants
- • Background: Heart failure is a major cause of morbidity and mortality in diabetes mellitus, but its pathophysiology is poorly understood
Who can take part?
- • Ages 50 Years to 75 Years
- • Diagnosed with diabetes mellitus, type 2
Where?
- • Leicester - University of Leicester
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 50 Years - 75 Years
- Who can join: All genders
What the study is looking for
- ✓Participant is willing and able to give agreement to take part 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...
Who cannot take part
- ✗Angina pectoris or limiting dyspnoea (\>NYHA II),
- ✗Major atherosclerotic disease: causing symptoms CAD, history of myocardial infarction, previous revascularisation,...
- ✗Atrial fibrillation or flutter.
- ✗Moderate or severe valvular heart disease.
- ✗History of heart failure or cardiomyopathy.
See the full criteria
Where Is This Study? (1 UK site)
University of Leicester
Leicester, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351How to Get in Touch
Gerry P McCann, MD
Sponsor contactCONTACT
Gaurav S Gulsin, MBChB(Hons)
Sponsor contactCONTACT