Single-center Clinical Study of Early Diagnosis of Diabetic Cardiomyopathy With FLIM
NCT ID: NCT04534894
Last Updated: 2020-09-01
Study Results
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Basic Information
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UNKNOWN
243 participants
OBSERVATIONAL
2020-10-01
2022-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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DM group and DCM group
DM group: type 2 diabetes with normal diastolic function DCM group: type 2 diabetes with diastolic dysfunction
fluorescence lifetime imaging microscopy
collect 2mL of venous blood and use fluorescence lifetime imaging microscopy to exam NADH fluorescence characteristics of it
Interventions
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fluorescence lifetime imaging microscopy
collect 2mL of venous blood and use fluorescence lifetime imaging microscopy to exam NADH fluorescence characteristics of it
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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guangyu chen, doctor
Role: STUDY_DIRECTOR
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Central Contacts
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References
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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. doi: 10.1016/0002-9149(72)90595-4. No abstract available.
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.
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.
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.
Suhling K, Siegel J, Lanigan PM, Leveque-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. doi: 10.1364/ol.29.000584.
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. eCollection 2017 Dec.
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.
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.
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 Head Neck Surg. 2010 Feb;136(2):126-33. doi: 10.1001/archoto.2009.216.
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 heart failure. Biomed Opt Express. 2015 Jan 7;6(2):324-46. doi: 10.1364/BOE.6.000324. eCollection 2015 Feb 1.
Other Identifiers
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XH-20-015
Identifier Type: -
Identifier Source: org_study_id
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