Viewing Study NCT04390711



Ignite Creation Date: 2024-05-06 @ 2:41 PM
Last Modification Date: 2024-10-26 @ 1:35 PM
Study NCT ID: NCT04390711
Status: COMPLETED
Last Update Posted: 2020-05-18
First Post: 2020-05-08

Brief Title: Association of Carbamylated HDL and CAD in T2DM Patients
Sponsor: RenJi Hospital
Organization: RenJi Hospital

Study Overview

Official Title: An Observational Cross-sectional Study to Compare Carbamylated High-density Lipoprotein Levels Among Normal Subjects Type 2 Diabetes Mellitus Patients With and Without Coronary Heart Disease
Status: COMPLETED
Status Verified Date: 2020-05
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: This is an observational cross-sectional study aimed at investigating the alterations of the carbamylated-HDL levels in T2DM patients and comparing the concentration of carbamylated-HDL between the T2DM patients with CAD and without CAD to explore the association between carbamylated-HDL and risk of CAD in T2DM patients
Detailed Description: High-density lipoprotein HDL is involved in various atheroprotective processes including reverse cholesterol transport inhibition of lipid oxidation and inflammatory cytokine secretion endothelial repair and antiapoptotic function which all contribute to the regression of plague burden Recent studies have shown that oxidative stress and chronic inflammation - both implicated in the process of diabetes - can contribute to an irreversible post-translational modification called carbamylation Carbamylation levels reflect the burden of enhanced inflammation oxidative stress and renal impairment and can serve as a biomarker of certain pathological conditions Several clinical studies have demonstrated positive associations between cardiovascular risk mortality and serum carbamylation-derived product levels in the general population and particularly in patients with kidney failure Increasing evidence also shows that carbamylated lipoprotein plays a pivotal role in atherosclerosis18 However most studies concerning carbamylation have been performed under a kidney disease background Whether HDL particles in patients with type 2 diabetes mellitus T2DM show enhanced carbamylation and whether this enhancement is associated with vascular complications remains unknown Thus in the present study the investigators aim to test whether HDL experiences carbamylation in T2DM patients and investigated the pro-atherogenic effects of carbamylated HDL on endothelial-monocyte adhesion

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