Association of Carbamylated HDL and CAD in T2DM Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Type 2 Diabetes Mellitus With Circulatory Complciation

Intervention / Treatment
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* Other: High density lipoprotein isolation, detection and in-vitro study.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1:Clinical diagnosis of T2DM (according to the criteria of the American Diabetes Association.) Exclusion Criteria: end-stage renal disease (ESRD) acute coronary syndrome, heart failure, chronic viral or bacterial infection, cancer, immune system disorders

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy subjects<br>We included 40 age- and gender-matched healthy subjects to serve as the control group, who had normal blood pressure, serum fasting glucose, lipid profile, and renal function. | Other: High density lipoprotein isolation, detection and in-vitro study.<br>* 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.<br>|
| T2DM with CAD<br>Diagnosis of T2DM was made according to the criteria of the American Diabetes Association. All patients were tested by angiography, with CAD diagnosed if luminal diameter narrowing was estimated visually at ≥50% in a major epicardial coronary artery. | Other: High density lipoprotein isolation, detection and in-vitro study.<br>* 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.<br>|
| T2DM without CAD<br>Diagnosis of T2DM was made according to the criteria of the American Diabetes Association.T2DM without CAD was diagnosed if no luminal diameter narrowing was estimated visually at ≥50% in a major epicardial coronary artery. | Other: High density lipoprotein isolation, detection and in-vitro study.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carbamylated-HDL levels alteration between the control and the T2DM patients with and without concomitant CAD. | HDL was isolated from subjects' plasma and its carbamylation levels were further detected by the enzyme-linked immunosorbent assay | within 1week after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carbamylation,HDL,T2DM