Coronary Heart Disease, Type 2 Diabetes Mellitus
Conditions
Keywords
gut microbiome, Type 2 Diabetes mellitus, coronary heart disease, glycemic variability
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.
Interventions
DEVICEContinuous 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.
Sponsors
Second Affiliated Hospital of Nanchang University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Clinical diagnosis of Type 2 Diabetes Mellitus (T2DM). Clinical diagnosis of Acute Coronary Syndrome (ACS).
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular events | 2023.7-2025.10 | Composite Major Adverse Cardiovascular Events (MACE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Angina requiring revascularisation | 2023.7-2025.10 | Presence of indications for coronary revascularisation |
| 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. |
Countries
China
Contacts
Primary ContactYunFeng Shen, PhD degree
Outcome results
None listed