Ignite Creation Date:
2024-05-06 @ 6:24 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05659043
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-12-21
First Post:
2022-12-11
Brief Title:
Glycation of apoA-I and Diabetic Atherogenesis
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
The Impact of Glycation Modification of apoA-I on HDL Function and Atherogenesis in Type Diabetes Mellitus
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
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:
The goal of this study is to determine the relationship of apoprotein A-1 apoA-I glycation and development of diabetic atherosclerosis
ApoA-I is crucial for reverse cholesterol transport and anti-inflammationanti-atherosclersis functions of HDL However apoA-I is easily subjected to non-enzymatic glycation modification in diabetic milleu Our preliminary study has shown that apoA-I in HDL from type 2 diabetes mellitus T2DM patients with coronary artery disease CAD is significantly glycated and site specific glycation of apoA-I impairs HDL function and is related to the development of atherosclerosis To the best of our knowledge less clinical information regarding apoA-I glycation and CAD has been reported In this cross-sectional study by consecutively enrolling diabetic patients with two to three hundred or without CAD controls six to eight hundred in our hospital we will isolate their serum HDL and perform a qualitative and quantitative proteomic analysis of apoA-I glycation The relation of apoA-I glycation and HDL function and angiography-determined severity of CAD will be evaluated Later we will follow these diabetic patients to analyze the influence of apoA-I glycation on the outcome including plaque progression
ApoA-I is crucial for reverse cholesterol transport and anti-inflammationanti-atherosclersis functions of HDL However apoA-I is easily subjected to non-enzymatic glycation modification in diabetic milleu Our preliminary study has shown that apoA-I in HDL from type 2 diabetes mellitus T2DM patients with coronary artery disease CAD is significantly glycated and site specific glycation of apoA-I impairs HDL function and is related to the development of atherosclerosis To the best of our knowledge less clinical information regarding apoA-I glycation and CAD has been reported In this cross-sectional study by consecutively enrolling diabetic patients with two to three hundred or without CAD controls six to eight hundred in our hospital we will isolate their serum HDL and perform a qualitative and quantitative proteomic analysis of apoA-I glycation The relation of apoA-I glycation and HDL function and angiography-determined severity of CAD will be evaluated Later we will follow these diabetic patients to analyze the influence of apoA-I glycation on the outcome including plaque progression
Detailed Description:
The goal of this study is to determine the relationship of apoprotein A-1 apoA-I glycation and development of diabetic atherosclerosis
ApoA-I is crucial for reverse cholesterol transport and anti-inflammationanti-atherosclersis functions of HDL However apoA-I is easily subjected to non-enzymatic glycation modification in diabetic milleu Our preliminary study has shown that apoA-I in HDL from type 2 diabetes mellitus T2DM patients with coronary artery disease CAD is significantly glycated and site specific glycation of apoA-I impairs HDL function and is related to the severity of atherosclerosis To the best of our knowledge less clinical information regarding apoA-I glycation and CAD has been reported In this cross-sectional study we will consecutively enroll several hundred diabetic patients two to three hundred with no CAD less than stenosis of 25 in coronary CTA as controls And we will also consecutively enroll several hundred six to eight hundred angiographically established T2DM patients with CAD stenosis of 50 in coronary angiography Serum HDL of all participants will be isolated and a qualitative and quantitative proteomic analysis of apoA-I glycation will be performed by mass spectrometry The relation of apoA-I glycaiton and HDL function and angioraphy-determined severity of CAD will be evaluated Later we will follow these diabetic patients for approximately two years to analyze the influence of apoA-I glycation on the clinical outcomes stroke myocardial infarction hospitalization for heart failure death due to cardiovascular causes etc including plaque progression
ApoA-I is crucial for reverse cholesterol transport and anti-inflammationanti-atherosclersis functions of HDL However apoA-I is easily subjected to non-enzymatic glycation modification in diabetic milleu Our preliminary study has shown that apoA-I in HDL from type 2 diabetes mellitus T2DM patients with coronary artery disease CAD is significantly glycated and site specific glycation of apoA-I impairs HDL function and is related to the severity of atherosclerosis To the best of our knowledge less clinical information regarding apoA-I glycation and CAD has been reported In this cross-sectional study we will consecutively enroll several hundred diabetic patients two to three hundred with no CAD less than stenosis of 25 in coronary CTA as controls And we will also consecutively enroll several hundred six to eight hundred angiographically established T2DM patients with CAD stenosis of 50 in coronary angiography Serum HDL of all participants will be isolated and a qualitative and quantitative proteomic analysis of apoA-I glycation will be performed by mass spectrometry The relation of apoA-I glycaiton and HDL function and angioraphy-determined severity of CAD will be evaluated Later we will follow these diabetic patients for approximately two years to analyze the influence of apoA-I glycation on the clinical outcomes stroke myocardial infarction hospitalization for heart failure death due to cardiovascular causes etc including plaque progression
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