Impact of Glycemic Variability and Gut Microbiota and Metabolites on the Prognosis of Patients With Type 2 Diabetes Mellitus Combined With Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular events
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Type 2 Diabetes Mellitus (T2DM).
- •Clinical diagnosis of Acute Coronary Syndrome (ACS).
排除标准
- •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.
结局指标
主要结局
Major adverse cardiovascular events
时间窗: 2023.7-2025.10
Composite Major Adverse Cardiovascular Events (MACE)
次要结局
- cardiovascular mortality(2023.7-2025.10)
- ACS Recurrence(2023.7-2025.10)
- Acute decompensated heart failure requiring hospitalisation(2023.7-2025.10)
- Strokes requiring hospitalisation(2023.7-2025.10)
- Angina requiring revascularisation(2023.7-2025.10)