Diabetic Cardiomyopathies Clinical Trial
Official title:
Single-center Clinical Study of Early Diagnosis of Diabetic Cardiomyopathy With Fluorescence Lifetime Imaging Microscopy (FLIM)
Diabetic Cardiomyopathy (DCM) is disease of myocardial structure and function which is
independent of hypertension, coronary heart disease, heart valve abnormalities, and other
types of heart disease. DCM affects approximately 12% of diabetics and also appeared in some
patients with well-controlled blood glucose. There is no specific and effective diagnostic
method of DCM currently. Since it is well known that the dysfunction of myocardial metabolism
caused by hyperglycemia and insulin resistance induces DCM, the method of evaluation of the
metabolism will assist the diagnosis of DCM.
Nicotinamide adenine dinucleotide (phosphate) (NAD(P)H) is one of important coenzymes
involved in biological metabolism. Fluorescence lifetime microscopy (FLIM) can detect the
metabolic status based on the fluorescence characteristics of NAD(P)H. Previous studies have
reported that NAD(P)H fluorescence lifetime can be used to assess the metabolic status of
living cardiomyocytes cultured in vitro, and metabolism changes related to myocardial
infarction and heart failure in rats. the investigators detected the metabolic status by
label-free FLIM on the myocardial tissues and blood plasma in a rat model of type 2 diabetic
cardiomyopathy, and found FLIM could provide valuable information about the myocardial
metabolism by detecting the NAD(P)H fluorescence lifetime of blood plasma.
Recently, The investigators have explored the method of the FLIM in clinical study. The
investigators used FLIM to compare the NAD(P)H fluorescence lifetime of blood plasma in
healthy participants, type 2 diabetic patients with normal diastolic function and with
diastolic dysfunction. The results showed that the NAD(P)H fluorescence life parameter of a2
was lower in type 2 diabetic patients with diastolic dysfunction (30.5±2.7%) than in healthy
participants (41.5±4.8%) and type 2 diabetic patients with normal diastolic function
(37.8±3.7%). Therefore, The investigators propose FLIM can provide valuable information about
the myocardial metabolism, and it can be used as a non-invasive, label-free, and rapid
screening method of diagnosis of DCM.
In this study, the investigators will recruit 243 patients with type 2 diabetes and divide
them into two groups: normal diastolic function group (DM Group) and diastolic dysfunction
group (DCM Group), based on the symptoms, laboratory examination and echocardiographic
results. Then FLIM will be applied to detect the NAD(P)H fluorescence characteristics of
venous blood of all patients. After that, the correlation between the parameters of diastolic
function (E peak, E/E' ratio, left atrial volume, NT-proBNP) and the parameters of metabolism
status (NAD(P)H fluorescence life parameter of a2 and the ratio of bound state/free state
NAD(P)H) will be analyzed. This study will verify FLIM is helpful to diagnose DCM.
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