Glycemic Variability, Gut Microbiota, and Prognosis in T2DM With ACS

NCT06573060 | Unknown DMC

• 1 other identifier: DMACS20240719
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with type 2 diabetes mellitus (T2DM) diagnosed with acute coronary syndrome (ACS) by coronary angiography in the Second Affiliated Hospital of Nanchang University were consecutively included in a prospective cohort study. During the acute phase of ACS, blood glucose was monitored using a continuous glucose monitoring system (CGM) for 14 days, and for patients who had been hospitalised for less than 14 days, they continued to wear the CGM for monitoring blood glucose until 14 days after discharge. During this period, stool and serum samples were analysed for multi-omics (16s rRNA sequencing and metabolomics). Subsequently, a follow-up period of at least 1 year was performed to observe the patients for the occurrence of adverse cardiovascular events (MACE) during the follow-up period and to assess the impact of glycaemic variability and gut flora and its metabolites on the prognosis of patients with T2DM combined with ACS.

Conditions

Type 2 Diabetes Mellitus; Coronary Heart Disease

Keywords

gut microbiome; Type 2 Diabetes mellitus; coronary heart disease; glycemic variability

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events

  Composite Major Adverse Cardiovascular Events (MACE)

  2023.7-2025.10

Secondary Outcomes (5)

• cardiovascular mortality

  2023.7-2025.10

• ACS Recurrence

  2023.7-2025.10

• Angina requiring revascularisation

  2023.7-2025.10

• Acute decompensated heart failure requiring hospitalisation

  2023.7-2025.10

• Strokes requiring hospitalisation

  2023.7-2025.10

Study Arms (1)

ACS+T2DM

Patients with Type 2 Diabetes Mellitus (T2DM) diagnosed with Acute Coronary Syndrome (ACS) through coronary angiography.

Device: Continuous glucose monitoring

Interventions

Continuous glucose monitoring DEVICE

Subjects with T2DM and acute coronary syndrome (n=120) were fitted with continuous glucose monitors (CGM) to closely monitor their blood glucose levels continuously for 14 days.

ACS+T2DM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

120

You may qualify if:

• Clinical diagnosis of Type 2 Diabetes Mellitus (T2DM).
• Clinical diagnosis of Acute Coronary Syndrome (ACS).

You may not qualify if:

• History of hemodialysis.
• Recent antibiotic use within the past two weeks.
• Active malignant tumors.
• Pregnancy and breastfeeding.
• Inability to wear sensors due to severe skin conditions.
• Coagulation disorders, anemia, or abnormal hematocrit levels.
• Requirement for MRI during the sensor-wearing period.
• Inability to follow study instructions or deemed unsuitable for the trial by the treating clinician/nurse.
• Inability to understand informed consent or communicate with researchers due to cognitive decline or mental illness.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

Study Sites (1)

The Second Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, 330000, China

RECRUITING

Related Publications (2)

• Kosiborod M, Rathore SS, Inzucchi SE, Masoudi FA, Wang Y, Havranek EP, Krumholz HM. Admission glucose and mortality in elderly patients hospitalized with acute myocardial infarction: implications for patients with and without recognized diabetes. Circulation. 2005 Jun 14;111(23):3078-86. doi: 10.1161/CIRCULATIONAHA.104.517839. Epub 2005 Jun 6.

  PMID: 15939812 BACKGROUND

• Emerging Risk Factors Collaboration; Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, Ingelsson E, Lawlor DA, Selvin E, Stampfer M, Stehouwer CD, Lewington S, Pennells L, Thompson A, Sattar N, White IR, Ray KK, Danesh J. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet. 2010 Jun 26;375(9733):2215-22. doi: 10.1016/S0140-6736(10)60484-9.

  PMID: 20609967 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Faeces and blood

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Coronary Disease

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Xiaojuan Jiao

  Second Affiliated Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YunFeng Shen, PhD degree

CONTACT

+8618970819455; syf92@live.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 27, 2024
• Study Start: July 5, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: August 27, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)