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

NCT ID: NCT06573060

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-05

Study Completion Date

2025-09-30

Brief Summary

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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

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Conditions

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Type 2 Diabetes Mellitus Coronary Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ACS+T2DM

Patients with Type 2 Diabetes Mellitus (T2DM) diagnosed with Acute Coronary Syndrome (ACS) through coronary angiography.

Continuous glucose monitoring

Intervention Type DEVICE

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.

Interventions

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Continuous 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaojuan Jiao

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Nanchang University

Locations

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The Second Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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YunFeng Shen, PhD degree

Role: CONTACT

+8618970819455

Facility Contacts

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Yunfeng Shen

Role: primary

18970819455

Xiaojuan Jiao

Role: backup

18970819455

References

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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.

Reference Type BACKGROUND
PMID: 15939812 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20609967 (View on PubMed)

Other Identifiers

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DMACS20240719

Identifier Type: -

Identifier Source: org_study_id

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