NCT04390711

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
Last Updated

May 18, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

May 8, 2020

Last Update Submit

May 14, 2020

Conditions

Type 2 Diabetes Mellitus With Circulatory Complciation

Keywords

Carbamylation,HDL,T2DM

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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.

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.

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.

Interventions

High density lipoprotein isolation, detection and in-vitro study.OTHER

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.

Healthy subjectsT2DM with CADT2DM without CAD

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • end-stage renal disease (ESRD)
  • acute coronary syndrome,
  • heart failure,
  • chronic viral or bacterial infection,
  • cancer,
  • immune system disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rui Jin Hospital

Shanghai, China

Location

Related Publications (8)

  • Rosenson RS, Brewer HB Jr, Ansell BJ, Barter P, Chapman MJ, Heinecke JW, Kontush A, Tall AR, Webb NR. Dysfunctional HDL and atherosclerotic cardiovascular disease. Nat Rev Cardiol. 2016 Jan;13(1):48-60. doi: 10.1038/nrcardio.2015.124. Epub 2015 Sep 1.

    PMID: 26323267BACKGROUND

  • Sun JT, Liu Y, Lu L, Liu HJ, Shen WF, Yang K, Zhang RY. Diabetes-Invoked High-Density Lipoprotein and Its Association With Coronary Artery Disease in Patients With Type 2 Diabetes Mellitus. Am J Cardiol. 2016 Dec 1;118(11):1674-1679. doi: 10.1016/j.amjcard.2016.08.044. Epub 2016 Aug 30.

    PMID: 27666175BACKGROUND

  • Femlak M, Gluba-Brzozka A, Cialkowska-Rysz A, Rysz J. The role and function of HDL in patients with diabetes mellitus and the related cardiovascular risk. Lipids Health Dis. 2017 Oct 30;16(1):207. doi: 10.1186/s12944-017-0594-3.

    PMID: 29084567BACKGROUND

  • Delanghe S, Delanghe JR, Speeckaert R, Van Biesen W, Speeckaert MM. Mechanisms and consequences of carbamoylation. Nat Rev Nephrol. 2017 Sep;13(9):580-593. doi: 10.1038/nrneph.2017.103. Epub 2017 Jul 31.

    PMID: 28757635BACKGROUND

  • Sun JT, Yang K, Mao JY, Shen WF, Lu L, Wu QH, Wang YP, Wu LP, Zhang RY. Cyanate-Impaired Angiogenesis: Association With Poor Coronary Collateral Growth in Patients With Stable Angina and Chronic Total Occlusion. J Am Heart Assoc. 2016 Dec 16;5(12):e004700. doi: 10.1161/JAHA.116.004700.

    PMID: 27986757BACKGROUND

  • Long J, Vela Parada X, Kalim S. Protein Carbamylation in Chronic Kidney Disease and Dialysis. Adv Clin Chem. 2018;87:37-67. doi: 10.1016/bs.acc.2018.07.002. Epub 2018 Aug 23.

    PMID: 30342712BACKGROUND

  • Verbrugge FH, Tang WH, Hazen SL. Protein carbamylation and cardiovascular disease. Kidney Int. 2015 Sep;88(3):474-8. doi: 10.1038/ki.2015.166. Epub 2015 Jun 10.

    PMID: 26061545BACKGROUND

  • Chen Z, Ding S, Wang YP, Chen L, Mao JY, Yang Y, Sun JT, Yang K. Association of carbamylated high-density lipoprotein with coronary artery disease in type 2 diabetes mellitus: carbamylated high-density lipoprotein of patients promotes monocyte adhesion. J Transl Med. 2020 Dec 3;18(1):460. doi: 10.1186/s12967-020-02623-2.

    PMID: 33272295DERIVED

Study Officials

  • Song Ding, MD

    Department of Cardiology, Ren Ji Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2020

First Posted

May 15, 2020

Study Start

September 1, 2018

Primary Completion

March 30, 2019

Study Completion

March 30, 2019

Last Updated

May 18, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)