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Association of Carbamylated HDL and CAD in T2DM Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04390711
Recruitment Status : Completed
First Posted : May 15, 2020
Last Update Posted : May 18, 2020
Sponsor:
Collaborator:
Ruijin Hospital
Information provided by (Responsible Party):
RenJi Hospital

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.

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus With Circulatory Complciation Other: High density lipoprotein isolation, detection and in-vitro study.

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.

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Study Type : Observational
Actual Enrollment : 282 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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.
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : March 30, 2019
Actual Study Completion Date : March 30, 2019


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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390711


Locations
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China
Rui Jin Hospital
Shanghai, China
Sponsors and Collaborators
RenJi Hospital
Ruijin Hospital
Investigators
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Study Director: Song Ding, MD Department of Cardiology, Ren Ji Hospital
Publications:

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT04390711    
Other Study ID Numbers: c-HDL study
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RenJi Hospital:
Carbamylation,HDL,T2DM
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases