Metabolic Characteristics of Type 2 Diabetes Mellitus Combined With Acute Myocardial Infarction: A Untargeted Metabolomics Study
12,13-DHOME and Noradrenaline Are Associated With Occurrence of Acute Myocardial Infarction in Patients With Type 2 Diabetes Mellitus: A Untargeted Metabolomics Study
1 other identifier
observational
82
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2020
CompletedFirst Submitted
Initial submission to the registry
October 18, 2022
CompletedFirst Posted
Study publicly available on registry
November 1, 2022
CompletedNovember 1, 2022
October 1, 2022
3 years
October 18, 2022
October 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
There are differences in the metabolic profile of diabetic patients with or without combined acute myocardial infarction
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
Study Arms (3)
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
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.
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weiping Li
Beijing, Beijing Municipality, 100032, China
Biospecimen
Serum
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Weiping Li, MD
Beijing Friendship Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chief physician
Study Record Dates
First Submitted
October 18, 2022
First Posted
November 1, 2022
Study Start
May 23, 2017
Primary Completion
May 28, 2020
Study Completion
May 28, 2020
Last Updated
November 1, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share