Cardiac Function and Microcirculation: Type 2 DIABetes and ECHOcardiographic Changes Over Time
- Conditions
- Left Ventricular Dysfunction
- Registration Number
- NCT02956577
- Lead Sponsor
- Svendborg Hospital
- Brief Summary
The purpose of this study was to investigate the influence of micro- and macrovascular changes on the cardiac function in relation to left ventricular function and coronary arteries during one year in patients with type 2 diabetes.
- Detailed Description
The most frequent heart disease in patients with Type 2 Diabetes Mellitus (T2DM) is the premature development of coronary atherosclerosis, which often leads to overt ischemic heart disease (IHD). T2DM can lead to both cardiac dysfunction due to IHD or to diabetic cardiomyopathy. Diabetic cardiomyopathy is defined as an impairment of left ventricular (LV) function without overt obstructive coronary vessel disease. Diabetic cardiomyopathy has been associated with microvascular dysfunction, which leads to the inability of the heart to circulate blood effectively. The microvascular atherosclerotic changes are well known in patients with diabetes, such as impaired vision, kidney function and sensibility. The macrovascular atherosclerotic changes such as plaques in the coronary arteries are strongly associated with reduced left ventricular function.
However, the relationship between micro- and macrovascular atherosclerotic changes and the impact on cardiac function is less certain.
Estimation of cardiac function includes: Left Atrial (LA) Strain, LA Strain Rate (SR), LA Emptying Function (LAEF), LV Ejection Fraction (EF), Fractional Shortening (FS), Global Longitudinal Strain (GLS), Circumferential Strain (CS) and Radial Strain (RS), Strain Rate (SR), Peak Systolic Strain, Post Systolic Strain, Early mitral filling velocity (E), late mitral filling velocity (A), E/A ratio, Deceleration Time (DCT) of early mitral filling velocity, medial and lateral mitral velocities using tissue doppler (e' , a' and s'), E/e' ratio, Isovolumetric Relaxation Time (IVRT), Isovolumetric Closing Time (IVCT), Ejection Time (ET), Myocardial Performance Index (MPI) and Myocardial Work Index (MWI).
In this study, participants will be consisting of non-diabetic subjects and patients with diabetes type 1 + 2. All of the participants have no history of myocardial infarction, heart failure and current symptoms of cardiac disease.
The study population will undergo following examinations:
1. 12-lead electrocardiogram (ECG)
2. Urine- and blood samples.
3. Measurements of anthropometric data and vital parameters
4. Recording of medical history
5. 2D transthoracic echocardiography
6. Coronary flow velocity reserve (CFVR) with adenosine infusion.
7. Coronary computed tomography angiography (CCTA).
8. Free fractional reserve computed tomography (FFR-CT)
The examinations will be repeated at follow-up (however non-diabetic subjects will only have 1 CCTA performed at baseline).
The non-invasive FFR-CT will only be performed once in a subgroup of diabetic patients and non-diabetic subjects from November 2016 until May 2017.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in Global Longitudinal Strain (GLS) stratified by Coronary Artery Calcium Score (CAC) in patients with diabetes during one year of follow-up baseline, 12 months To evaluate the changes in GLS stratified by CAC during one year of follow-up in patients with diabetes compared to non-diabetic subjects
- Secondary Outcome Measures
Name Time Method Changes in LV function stratified by CFVR baseline, 12 months To evaluate LV systolic and diastolic function stratified by CFVR in patients with diabetes compared to non-diabetic subjects.
Changes in GLS stratified by Coronary Flow Velocity Reserve (CFVR) in patients with diabetes during one year of follow-up baseline, 12 months To evaluate the changes in GLS stratified by CFVR during one year of follow-up in patients with diabetes compared to non-diabetic subjects
Correlation between biomarkers and GLS stratified by CAC 12 months To evaluate the correlation between biomarkers (C-Reactive Protein, Troponin T, NT-proBNP and Uric Acid) and GLS stratified by CAC in diabetic patients compared to non-diabetic subjects
Correlation between CFVR and Free Fractional Reserve -Computed Tomography (FFR-CT) baseline To evaluate the correlation between CFVR and FFR-CT in a subgroup consisting of diabetic patients and non-diabetic subjects.
Correlation between GLS and FFR-CT baseline To evaluate the correlation between GLS and non-invasive FFR-CT in a subgroup consisting of diabetic patients and non-diabetic subjects.
Correlation between biomarkers and GLS stratified by CFVR 12 months To evaluate the correlation between biomarkers (C-Reactive Protein, Troponin T, NT-proBNP and Uric Acid) and GLS stratified by CFVR in diabetic patients compared to non-diabetic subjects
Changes in LV function stratified by CAC baseline, 12 months To evaluate LV systolic and diastolic function stratified by CAC in patients with diabetes compared to non-diabetic subjects.
Changes in LV function stratified by micro- and macrovascular diabetic status baseline, 12 months To evaluate changes in LV systolic and diastolic function in relation to albuminuria, retinopathy, neuropathy, diabetes duration and CAC.
Changes in GLS in patients with long-term diabetes and no macrovascular disease baseline To evaluate the impact of historical varying levels of HbA1c and cholesterols on GLS at baseline in patients with diabetes and no macrovascular disease.
Trial Locations
- Locations (1)
Cardiovascular Research Unit, OUH Svendborg Hospital
🇩🇰Svendborg, Denmark