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Association of Carbamylated HDL and CAD in T2DM Patients

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04390711
Enrollment
282
Registered
2020-05-15
Start date
2018-09-01
Completion date
2019-03-30
Last updated
2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus With Circulatory Complciation

Keywords

Carbamylation,HDL,T2DM

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 atherosclerosis.18 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.

Interventions

OTHERHigh density lipoprotein isolation, detection and in-vitro study.

All blood samples were taken on the day of cardiac catheterization after overnight fasting.High density lipoprotein from each participants was isolated and further collected for carbamylation level detection and in-vitro study.

Sponsors

Ruijin Hospital
CollaboratorOTHER
RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

1:Clinical diagnosis of T2DM (according to the criteria of the American Diabetes Association.)

Exclusion criteria

1. end-stage renal disease (ESRD) 2. acute coronary syndrome, 3. heart failure, 4. chronic viral or bacterial infection, 5. cancer, 6. immune system disorders

Design outcomes

Primary

MeasureTime frameDescription
Carbamylated-HDL levels alteration between the control and the T2DM patients with and without concomitant CAD.within 1week after enrollmentHDL was isolated from subjects' plasma and its carbamylation levels were further detected by the enzyme-linked immunosorbent assay

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026