Metabolic Characteristics of Type 2 Diabetes Mellitus Combined With Acute Myocardial Infarction: A Untargeted Metabolomics Study

Sponsor

Beijing Friendship Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05601310

Collaborator

(none)

Enrollment

Location

36.2

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a retrospective case-control study. In this study, through untargeted metabolomics, investigators identified several specific changed serum metabolites in T2DM patients with or without AMI and their functions/category. Moreover, researchers selected several endogenous candidate biomarkers with larger fold change for validation in expanded population to find biomarkers which effectively predict the development of STEMI in patients with T2DM.

Condition or Disease	Intervention/Treatment	Phase
STEMI	Device: liquid chromatography-mass spectrometry (LC/MS) analysis

Study Design

Study Type:

Observational

Actual Enrollment :

82 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

12,13-DHOME and Noradrenaline Are Associated With Occurrence of Acute Myocardial Infarction in Patients With Type 2 Diabetes Mellitus: A Untargeted Metabolomics Study

Actual Study Start Date :

May 23, 2017

Actual Primary Completion Date :

May 28, 2020

Actual Study Completion Date :

May 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Control group in the group, the participants exhibited negative results or <50% obstruction upon coronary artery CT or coronary angiography. The group did not have coronary heart disease and diabetes	Device: liquid chromatography-mass spectrometry (LC/MS) analysis To obtain a complete metabolic profile, untargeted metabolomics analysis was conducted by using UPLC-MS. Chromatographic separation was accomplished in an Thermo Vanquish system equipped with an ACQUITY UPLC®HSS T3 (150×2.1 mm, 1.8 µm, Waters, USA) column maintained at 40 ℃. The temperature of the autosampler was 8 ℃. The ESI-MSn experiments were executed on the Thermo Q Exactive mass spectrometer with the spray voltage of 3.5 kV and -2.5 kV in positive and negative modes, respectively. The capillary temperature was 325℃. The analyzer scanned over a mass range of m/z 81-1 000 for full scan at a mass resolution of 70 000. The normalized collision energy was 30 eV(19606840). The detected ions were all under isotopic calibration with the accurate masses of the reference standards.
T2DM group in the group, the participants exhibited negative results or <50% obstruction upon coronary artery CT or coronary angiography. The group did not have coronary heart disease but have type 2 diabetes mellitus.	Device: liquid chromatography-mass spectrometry (LC/MS) analysis To obtain a complete metabolic profile, untargeted metabolomics analysis was conducted by using UPLC-MS. Chromatographic separation was accomplished in an Thermo Vanquish system equipped with an ACQUITY UPLC®HSS T3 (150×2.1 mm, 1.8 µm, Waters, USA) column maintained at 40 ℃. The temperature of the autosampler was 8 ℃. The ESI-MSn experiments were executed on the Thermo Q Exactive mass spectrometer with the spray voltage of 3.5 kV and -2.5 kV in positive and negative modes, respectively. The capillary temperature was 325℃. The analyzer scanned over a mass range of m/z 81-1 000 for full scan at a mass resolution of 70 000. The normalized collision energy was 30 eV(19606840). The detected ions were all under isotopic calibration with the accurate masses of the reference standards.
T2DM+AMI group In the group, we eventually recruited 30 adult patients who were firstly diagnosed ST-elevation myocardial infarction (STEMI) within 12 hours of appearance chest pains or other AMI symptoms and had no previous history of coronary artery disease (CAD). Peripheral venous blood samples were drawn from subjects on admission or prior to coronary revascularization.	Device: liquid chromatography-mass spectrometry (LC/MS) analysis To obtain a complete metabolic profile, untargeted metabolomics analysis was conducted by using UPLC-MS. Chromatographic separation was accomplished in an Thermo Vanquish system equipped with an ACQUITY UPLC®HSS T3 (150×2.1 mm, 1.8 µm, Waters, USA) column maintained at 40 ℃. The temperature of the autosampler was 8 ℃. The ESI-MSn experiments were executed on the Thermo Q Exactive mass spectrometer with the spray voltage of 3.5 kV and -2.5 kV in positive and negative modes, respectively. The capillary temperature was 325℃. The analyzer scanned over a mass range of m/z 81-1 000 for full scan at a mass resolution of 70 000. The normalized collision energy was 30 eV(19606840). The detected ions were all under isotopic calibration with the accurate masses of the reference standards.

Arm

Intervention/Treatment

Control group

in the group, the participants exhibited negative results or <50% obstruction upon coronary artery CT or coronary angiography. The group did not have coronary heart disease and diabetes

Device: liquid chromatography-mass spectrometry (LC/MS) analysis

To obtain a complete metabolic profile, untargeted metabolomics analysis was conducted by using UPLC-MS. Chromatographic separation was accomplished in an Thermo Vanquish system equipped with an ACQUITY UPLC®HSS T3 (150×2.1 mm, 1.8 µm, Waters, USA) column maintained at 40 ℃. The temperature of the autosampler was 8 ℃. The ESI-MSn experiments were executed on the Thermo Q Exactive mass spectrometer with the spray voltage of 3.5 kV and -2.5 kV in positive and negative modes, respectively. The capillary temperature was 325℃. The analyzer scanned over a mass range of m/z 81-1 000 for full scan at a mass resolution of 70 000. The normalized collision energy was 30 eV(19606840). The detected ions were all under isotopic calibration with the accurate masses of the reference standards.

T2DM group

in the group, the participants exhibited negative results or <50% obstruction upon coronary artery CT or coronary angiography. The group did not have coronary heart disease but have type 2 diabetes mellitus.

Device: liquid chromatography-mass spectrometry (LC/MS) analysis

T2DM+AMI group

In the group, we eventually recruited 30 adult patients who were firstly diagnosed ST-elevation myocardial infarction (STEMI) within 12 hours of appearance chest pains or other AMI symptoms and had no previous history of coronary artery disease (CAD). Peripheral venous blood samples were drawn from subjects on admission or prior to coronary revascularization.

Device: liquid chromatography-mass spectrometry (LC/MS) analysis

Outcome Measures

Primary Outcome Measures

There are differences in the metabolic profile of diabetic patients with or without combined acute myocardial infarction [December 16th, 2020]
About 10ml of venous blood was collected on the admission, serum was separated. To obtain a complete metabolic profile, untargeted metabolomics analysis was conducted by using UPLC-MS.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

STEMI patients meet the diagnostic criteria of "Guidelines for the Diagnosis and Treatment of Acute ST-segment Elevation Myocardial Infarction (2015)".
STMEI patients undergoing emergency PCI should undergo emergency PCI within 12 hours of onset at Beijing Friendship Hospital affiliated to Capital Medical University.
All diabetic patients meet the diagnostic criteria for type 2 diabetes.
They agreed to be enrolled in the trial and signed the informed consent.

Exclusion Criteria:

Combined with severe valvular disease or congenital heart disease, hypertension, chronic kidney disease, stroke, hyperlipidemia, previous history of coronary artery disease.
Involved in acute infection, severe hepatic dysfunction, tumor, rheumatic immune disease.
Incomplete clinical information.