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

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Nanchang University

Status

Enrolling

Conditions

Coronary Heart Disease
Type 2 Diabetes Mellitus

Treatments

Device: Continuous glucose monitoring

Study type

Observational

Funder types

Other

Identifiers

NCT06573060
DMACS20240719

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

120 participants in 1 patient group

ACS+T2DM
Description:
Patients with Type 2 Diabetes Mellitus (T2DM) diagnosed with Acute Coronary Syndrome (ACS) through coronary angiography.
Treatment:
Device: Continuous glucose monitoring

Trial contacts and locations

1

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Central trial contact

YunFeng Shen, PhD degree

Data sourced from clinicaltrials.gov

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