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

STEMI Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05601310
• Other study ID #: BFH-Metabolomics and STEMI
• Status: Completed
• Start date: May 23, 2017
• Est. completion date: May 28, 2020

Study information

• Verified date: October 2022
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 28, 2020
• Est. primary completion date: May 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Infarction
• Myocardial Infarction
• STEMI

Intervention

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.

Locations

Country	Name	City	State
China	Weiping Li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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