Association of Carbamylated HDL and CAD in T2DM Patients

May 14, 2020 updated by: RenJi Hospital

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

282

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Rui Jin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Between September 2018 to March 2019, a total of 242 consecutive T2DM patients who visited Shanghai Ruijin Hospital were enrolled in this study. All patients were tested by angiography, with CAD diagnosed if luminal diameter narrowing was estimated visually at ≥50% in a major epicardial coronary artery. Patients with end-stage renal disease (ESRD) (n = 9), acute coronary syndrome(n = 25), heart failure (n = 21), chronic viral or bacterial infection (n = 7), tumors(n = 8), or immune system disorders (n = 3) were excluded from this study. 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy subjects
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.
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.
T2DM with CAD
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.
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.
T2DM without CAD
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.
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.

What is the study measuring?

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.
Time Frame: within 1week after enrollment
HDL was isolated from subjects' plasma and its carbamylation levels were further detected by the enzyme-linked immunosorbent assay
within 1week after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

Ruijin Hospital

Investigators

  • Study Director: Song Ding, MD, Department of Cardiology, Ren Ji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

March 30, 2019

Study Completion (Actual)

March 30, 2019

Study Registration Dates

First Submitted

May 8, 2020

First Submitted That Met QC Criteria

May 14, 2020

First Posted (Actual)

May 15, 2020

Study Record Updates

Last Update Posted (Actual)

May 18, 2020

Last Update Submitted That Met QC Criteria

May 14, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • c-HDL study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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