Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04534894
Status:
UNKNOWN
Last Update Posted:
2020-09-01
First Post:
2020-08-19
Brief Title:
Single-center Clinical Study of Early Diagnosis of Diabetic Cardiomyopathy With FLIM
Sponsor:
Xinhua Hospital Shanghai Jiao Tong University School of Medicine
Organization:
Xinhua Hospital Shanghai Jiao Tong University School of Medicine
Study Overview
Official Title:
Single-center Clinical Study of Early Diagnosis of Diabetic Cardiomyopathy With Fluorescence Lifetime Imaging Microscopy FLIM
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 NADPH is one of important coenzymes involved in biological metabolism Fluorescence lifetime microscopy FLIM can detect the metabolic status based on the fluorescence characteristics of NADPH Previous studies have reported that NADPH 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 NADPH 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 NADPH 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 NADPH fluorescence life parameter of a2 was lower in type 2 diabetic patients with diastolic dysfunction 30527 than in healthy participants 41548 and type 2 diabetic patients with normal diastolic function 37837 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 NADPH fluorescence characteristics of venous blood of all patients After that the correlation between the parameters of diastolic function E peak EE ratio left atrial volume NT-proBNP and the parameters of metabolism status NADPH fluorescence life parameter of a2 and the ratio of bound statefree state NADPH will be analyzed This study will verify FLIM is helpful to diagnose DCM
Nicotinamide adenine dinucleotide phosphate NADPH is one of important coenzymes involved in biological metabolism Fluorescence lifetime microscopy FLIM can detect the metabolic status based on the fluorescence characteristics of NADPH Previous studies have reported that NADPH 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 NADPH 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 NADPH 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 NADPH fluorescence life parameter of a2 was lower in type 2 diabetic patients with diastolic dysfunction 30527 than in healthy participants 41548 and type 2 diabetic patients with normal diastolic function 37837 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 NADPH fluorescence characteristics of venous blood of all patients After that the correlation between the parameters of diastolic function E peak EE ratio left atrial volume NT-proBNP and the parameters of metabolism status NADPH fluorescence life parameter of a2 and the ratio of bound statefree state NADPH will be analyzed This study will verify FLIM is helpful to diagnose DCM
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None