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.
Status | Not yet recruiting |
Enrollment | 243 |
Est. completion date | December 31, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Male or female, aged 18-80 years old; 2. Echocardiography showed that the cardiac structure was normal and the left ventricular ejection fraction was more than 50%; 3. patients with type 2 diabetes mellitus; 4. Body mass index (BMI) was 20-25 kg / m2 in male and 19-24 kg / m2 in female; 5. No other drugs except hypoglycemic drugs were taken in one month; 6. Sign informed consent form before entering this study. Exclusion Criteria: 1. Patients with type 1 diabetes mellitus; 2. Patients with diabetic ketoacidosis in the past; 3. Patients with coronary heart disease or with myocardial ischemia indicated by ECG; 4. EGFR < 60ml / min / 1.73m2 in recent one month; 5. Chronic liver disease, or the levels of alanine aminotransferase and glutamic oxaloacetic transaminase were more than 3 times of the upper limit of the normal before enrollment; 6. Abnormal thyroid function; 7. Abnormal tumor index; 8. Dyslipidemia; 9. Pregnant and lactating women; 10. Allergy to contrast media. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
Cook GA, Lavrentyev EN, Pham K, Park EA. Streptozotocin diabetes increases mRNA expression of ketogenic enzymes in the rat heart. Biochim Biophys Acta Gen Subj. 2017 Feb;1861(2):307-312. doi: 10.1016/j.bbagen.2016.11.012. Epub 2016 Nov 11. — View Citation
De Jong KA, Lopaschuk GD. Complex Energy Metabolic Changes in Heart Failure With Preserved Ejection Fraction and Heart Failure With Reduced Ejection Fraction. Can J Cardiol. 2017 Jul;33(7):860-871. doi: 10.1016/j.cjca.2017.03.009. Epub 2017 Mar 19. Review — View Citation
Farwell DG, Meier JD, Park J, Sun Y, Coffman H, Poirier B, Phipps J, Tinling S, Enepekides DJ, Marcu L. Time-resolved fluorescence spectroscopy as a diagnostic technique of oral carcinoma: Validation in the hamster buccal pouch model. Arch Otolaryngol Hea — View Citation
Jing Y, Wang Y, Wang X, Song C, Ma J, Xie Y, Fei Y, Zhang Q, Mi L. Label-free imaging and spectroscopy for early detection of cervical cancer. J Biophotonics. 2018 May;11(5):e201700245. doi: 10.1002/jbio.201700245. Epub 2018 Jan 30. — View Citation
Lagarto J, Dyer BT, Talbot C, Sikkel MB, Peters NS, French PM, Lyon AR, Dunsby C. Application of time-resolved autofluorescence to label-free in vivo optical mapping of changes in tissue matrix and metabolism associated with myocardial infarction and hear — View Citation
Luo T, Lu Y, Liu S, Lin D, Qu J. Phasor-FLIM as a Screening Tool for the Differential Diagnosis of Actinic Keratosis, Bowen's Disease, and Basal Cell Carcinoma. Anal Chem. 2017 Aug 1;89(15):8104-8111. doi: 10.1021/acs.analchem.7b01681. Epub 2017 Jul 18. — View Citation
Rubler S, Dlugash J, Yuceoglu YZ, Kumral T, Branwood AW, Grishman A. New type of cardiomyopathy associated with diabetic glomerulosclerosis. Am J Cardiol. 1972 Nov 8;30(6):595-602. — View Citation
Singh RM, Waqar T, Howarth FC, Adeghate E, Bidasee K, Singh J. Hyperglycemia-induced cardiac contractile dysfunction in the diabetic heart. Heart Fail Rev. 2018 Jan;23(1):37-54. doi: 10.1007/s10741-017-9663-y. Review. — View Citation
Suhling K, Siegel J, Lanigan PM, Lévêque-Fort S, Webb SE, Phillips D, Davis DM, French PM. Time-resolved fluorescence anisotropy imaging applied to live cells. Opt Lett. 2004 Mar 15;29(6):584-6. — View Citation
Wang M, Tang F, Pan X, Yao L, Wang X, Jing Y, Ma J, Wang G, Mi L. Rapid diagnosis and intraoperative margin assessment of human lung cancer with fluorescence lifetime imaging microscopy. BBA Clin. 2017 Apr 27;8:7-13. doi: 10.1016/j.bbacli.2017.04.002. eCo — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | fluorescence characteristics of NAD(P)H in venous blood by FLIM can assist early diagnosis of diabetic cardiomyopathy | (NAD(P)H fluorescence life parameter of a2 (%) in venous blood is lower in DCM patients than DM patients. | 12 month | |
Primary | fluorescence characteristics of NAD(P)H in venous blood by FLIM can assist early diagnosis of diabetic cardiomyopathy | the ratio of bound state/free state NAD(P)H) (%) is lower in DCM patients than DM patients. | 12 month |
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