Glycemic Variability, Gut Microbiota, and Prognosis in T2DM With ACS
- Conditions
- Type 2 Diabetes MellitusCoronary Heart Disease
- Interventions
- Device: Continuous glucose monitoring
- Registration Number
- NCT06573060
- Lead Sponsor
- Second Affiliated Hospital of Nanchang University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
Clinical diagnosis of Type 2 Diabetes Mellitus (T2DM).
Clinical diagnosis of Acute Coronary Syndrome (ACS).
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ACS+T2DM Continuous glucose monitoring Patients with Type 2 Diabetes Mellitus (T2DM) diagnosed with Acute Coronary Syndrome (ACS) through coronary angiography.
- Primary Outcome Measures
Name Time Method Major adverse cardiovascular events 2023.7-2025.10 Composite Major Adverse Cardiovascular Events (MACE)
- Secondary Outcome Measures
Name Time Method cardiovascular mortality 2023.7-2025.10 Deaths due to heart and/or vascular disease. According to the World Health Organisation (WHO) classification, cardiovascular diseases include a wide range of diseases such as coronary heart disease, myocardial infarction, stroke and hypertension.
ACS Recurrence 2023.7-2025.10 Refers to the recurrence of a new ACS event after an episode of ACS. Depending on the signs and symptoms, patients can be classified as having STEMI, NSTEMI, or unstable angina.
Acute decompensated heart failure requiring hospitalisation 2023.7-2025.10 Clinical syndrome caused by acute imbalance of oxygen supply and demand due to impaired cardiac function, manifested by dyspnoea, pulmonary oedema and peripheral oedema. The patient's condition is severe enough to require hospitalisation.
Strokes requiring hospitalisation 2023.7-2025.10 An acute disease with sudden defects in brain function, such as sudden motor, sensory, speech, and vision disorders. The patient's condition is serious enough to require hospitalisation for treatment and observation.
Angina requiring revascularisation 2023.7-2025.10 Presence of indications for coronary revascularisation
Trial Locations
- Locations (1)
The Second Affiliated Hospital Of Nanchang University
🇨🇳Nanchang, Jiangxi, China