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

October 26, 2022 updated by: Weiping Li, Beijing Friendship Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

82

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
    • Beijing
      • Beijing, Beijing, China, 100032
        • Weiping Li

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

① Patients with acute ST-segment elevation myocardial infarction (STEMI) who underwent emergency PCI in Beijing Friendship Hospital (Xicheng District) affiliated to Capital Medical University. ②In the Beijing Friendship Hospital (Xicheng District) affiliated to Capital Medical University, coronary angiography showed negative coronary angiography or coronary artery CT showed <50% obstruction in patients with non-coronary heart disease.

Description

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.

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
There are differences in the metabolic profile of diabetic patients with or without combined acute myocardial infarction
Time Frame: 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.
December 16th, 2020

Collaborators and Investigators

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

Sponsor

Beijing Friendship Hospital

Investigators

  • Study Director: Weiping Li, MD, Beijing Friendship Hospital

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)

May 23, 2017

Primary Completion (ACTUAL)

May 28, 2020

Study Completion (ACTUAL)

May 28, 2020

Study Registration Dates

First Submitted

October 18, 2022

First Submitted That Met QC Criteria

October 26, 2022

First Posted (ACTUAL)

November 1, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 26, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BFH-Metabolomics and STEMI

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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