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

Completed

• Conditions: STEMI
• Interventions: Device: liquid chromatography-mass spectrometry (LC/MS) analysis

• Registration Number: NCT05601310
• Lead Sponsor: Beijing Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-23
• Primary Completion: 2020-05-28
• Study Completion: 2020-05-28
• Status Verified: 2022-10
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-26
• Last Update Submitted: 2022-10-26
• Study First Posted: 2022-11-01
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	liquid chromatography-mass spectrometry (LC/MS) analysis	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+AMI group	liquid chromatography-mass spectrometry (LC/MS) analysis	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.
T2DM group	liquid chromatography-mass spectrometry (LC/MS) analysis	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Weiping Li; 🇨🇳 Beijing, Beijing, China