NCT06573060

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

Impact of Glycemic Variability and Gut Microbiota and Metabolites on the Prognosis of Patients With Type 2 Diabetes Mellitus Combined With Acute Coronary Syndrome

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Second Affiliated Hospital of Nanchang University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Continuous glucose monitoring	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.

Timeline

• Start date: 2023-07-05
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2024-08-27
• Last updated: 2024-08-27

Locations

1 site across 1 country: China