Clinical trial NCT06573060: Glycemic Variability, Gut Microbiota, and Prognosis in T2DM With ACS
Official title: Impact of Glycemic Variability and Gut Microbiota and Metabolites on the Prognosis of Patients With Type 2 Diabetes Mellitus Combined With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes Mellitus
Coronary Heart Disease
Keywords: gut microbiome
Type 2 Diabetes mellitus
coronary heart disease
glycemic variability
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 120

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 2023.7-2025.10
Secondary outcomes:
measure: cardiovascular mortality
timeFrame: 2023.7-2025.10
measure: ACS Recurrence
timeFrame: 2023.7-2025.10
measure: Angina requiring revascularisation
timeFrame: 2023.7-2025.10
measure: Acute decompensated heart failure requiring hospitalisation
timeFrame: 2023.7-2025.10
measure: Strokes requiring hospitalisation
timeFrame: 2023.7-2025.10
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The Second Affiliated Hospital Of Nanchang University
state: Jiangxi
Study officials:
affiliation: Second Affiliated Hospital of Nanchang University
name: Xiaojuan Jiao
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.