NCT03132129Recruiting
Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 5 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 593 (estimated)
- First submitted
- 19 Apr 2017
- Start date
- 24 Oct 2017
- Primary completion date
- 31 Oct 2029
- Lead sponsor
- University of Leicester
- Diseases
- Type 2 diabetes
- NCT number
- NCT03132129
What you commit to
- Study type: Observational
- Planned participants: 593
- From 24 Oct 2017 to the primary completion date, 31 Oct 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major atherosclerotic disease: Symptomatic CAD, history of myocardial infarction, previous revascularisation, stroke/transient ischaemic attack or symptomatic peripheral vascular disease.
Other illness
- Angina pectoris or limiting dyspnoea (\>NYHA II),
- Moderate or severe valvular heart disease.
- History of heart failure or cardiomyopathy.
- Type 1 diabetes mellitus (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.
Other
- Atrial fibrillation or flutter.
- Low fasting C-peptide levels suggestive of adult-onset T1DM.
Who the study is looking for
- 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%).
Age in the registry: 50 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Leicester Coordinator of this site? Confirm its status | Leicester | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.